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We’re developing 

treatment solutions. 

Australasian Leukaemia and Lymphoma Group 

Research Report 2011

You help us to do that. 

Our mission is to improve 

the treatment and the lives 

of patients with leukaemia, 

lymphoma and other 

haematological malignancies 

by advancing ‘leading edge’ 

clinical trials in Australasia, 

and to be regarded by the 

local and international 

community as the peak 

research body for these 

diseases within our 

geographical areas of 

operation and influence. 

Strategic Objectives 

Scientific outcomes 

Provide the framework to ensure that the Group 

sponsors, conducts and participates in relevant clinical 

trials of significance for the development of improved 

treatment for patients with leukaemia and lymphoma. 

Reputation 

To be regarded by local and international communities 

as the peak research body within our geographical 

sphere of operation and influence in the field 

of leukaemia and lymphoma. 

Membership 

Encourage all appropriately qualified clinicians and 

other professionals to be members of the ALLG 

and to be active participants in the trials sponsored 

by the Group. 

Governance and resources 

Ensure the long term maintainability of the Group with 

good corporate governance and appropriate financial 

and human resources to carry out the ALLG Mission. 

1

Contents 

8 A Short History of the Australasian Leukaemia 

and Lymphoma Group 

12 Chairman’s Report 

15 SAC Chairman’s Report 

18 Scientific Advisory Committee (SAC) 

20 Finance Report for FY Ended 30 June 2011 

22 Operations Office Report 

25 Membership and Participating Sites 

28 The National Leukaemia and Lymphoma Tissue Bank 

34 Safety and Data Monitoring Committee 

(SDMC) Report 

36 Marketing Committee Report 

38 Education and Grants 

42 Trial Centre Reports 

44 Collaborations 

46 ALLG Scientific Meeting 2011 Sponsors 

Trials in Progress 

Acute Leukaemia and Myelodysplasia 

50 Disease Group Report 

52 ALL5 

A Phase II study of Dasatinib combined with 

induction chemotherapy in previously untreated 

de novo Philadelphia Chromosome-Positive Acute 

Lymphoblastic Leukaemia 

53 ALL6 

A Phase II trial of an intensive pediatric protocol 

incorporating post-induction stratification based 

on MRD levels for the treatment of adolescents 

aged 15 years and above, and young adults aged 

up to 40 years, with newly diagnosed Acute 

Lymphoblastic Leukaemia (ALL) 

54 ALL7 

Phase 1 study of RAD001 (Everolimus) in 

combination with chemotherapy for treatment of 

relapsed adult Acute Lymphoblastic Leukemia (ALL) 

55 AMLM14 

A programme of development for older patients 

with Acute Myeloid Leukaemia and High Risk 

Myelodysplastic Syndrome [UK: NCR AML 16] 

56 AMLM15 

A pilot study exploring high-dose lenalidomide 

maintenance therapy in adult AML 

57 MDS4 

A Randomised Phase II study comparing the efficacy 

of 5azacitidine alone versus combination therapy with 

lenalidomide and 5azacitidine in patients with higher 

risk myelodysplastic syndromes (MDS) and low 

marrow blast count acute myeloid leukaemia (AML) 

Contents 

2

Bone Marrow Transplant (BMT) 


59 BM07 

A treatment algorithm evaluating the effect 

of zoledronic acid on bone mineral density loss 

after allogeneic stem cell transplantation 

Chronic Myeloid Leukaemia (CML)/ 

Myeloproliferative Neoplasms 


62 CML8 

Trial of withdrawing imatinib in CML patients 

in stable molecular remission 

63 CML9 

A Phase II study in adult patients with newly 

diagnosed chronic-phase chronic myeloid leukaemia 

of initial intensified imatinib therapy and sequential 

dose escalation followed by treatment with nilotinib 

in suboptimal responders to determine the rate and 

duration of major molecular response 

64 CML10 

Response post Tyrosine Kinase Inhibitor: assessment 

of sensitivity and therapeutic response to next-line 

therapy in CML: The Australasian RESIST study 

65 PT1 

A randomised trial to compare aspirin vs 

hydroxyurea/aspirin in intermediate risk 

primary thrombocythaemia and aspirin only 

in low risk primary thrombocythaemia 

High Grade Non-Hodgkin Lymphoma 

and Hodgkin Lymphoma 


68 HD8 

A randomised Phase III trial to assess response 

adapted therapy using FDG-PET imaging in patients 

with newly diagnosed, advanced Hodgkin Lymphoma 

69 NHL21 

Early treatment intensification with R-ICE 

chemotherapy and autologous stem cell 

transplantation for patients with poor prognosis 

diffuse large B-Cell lymphoma as identified 

by interim PET/CT scan performed after four 

cycles of R-CHOP-14 chemotherapy 

70 NHL24 

Rituximab in Primary Central Nervous system 

Lymphoma (A randomized HOVON/ALLG 

intergroup study) 

71 NHL25 

Double Blind Randomized Phase III study 

of lenalidomide (REVLIMID) maintenance 

versus placebo in responding elderly patients 

with DLBCL and treated with R-CHOP in first line 

Low Grade Non-Hodgkin Lymphoma/ 

Chronic Lymphocytic Leukaemia 


74 CLL5 

An Australian, phase II multicentre, open-label, 

dose intensification study investigating poFCivR in 

previously untreated elderly (≥ 65) patients with CLL 

75 CLL6 

An Australasian, Phase III, Multicentre, Randomised 

trial comparing Lenalidomide consolidation vs no 

consolidation in patients with Chronic Lymphocytic 

Leukemia and residual disease following induction 

chemotherapy (RESIDUUM) 

3


Chronic Lymphocytic Leukaemia (Continued) 

76 NHL15 

A prospective single arm trial of involved field 

radiotherapy alone for stage I–II low grade 

non-gastric marginal zone lymphoma 

77 NHLLOW5 

A randomised multicentre trial of involved field 

radiotherapy vs involved field radiotherapy plus 

chemotherapy in combination with Rituximab 

(Mabthera) for stage I–II low grade follicular lymphoma 

Myeloma 


80 MM11 

A Phase III, multicentre, randomized, controlled 

study to determine the efficacy and safety of 

cyclophosphamide, lenalidomide and dexamethasone 

(CRD) versus melphalan (200 mg/m2) followed 

by stem cell transplant in newly diagnosed Multiple 

Myeloma subjects 

81 MM13 

A randomized open-label multicenter phase III 

trial of Melphalan and Dexamethasone (MDex) 

versus Bortezomib, Melphalan and Dexamethasone 

(BMDex) for untreated patients with systemic 

light-chain (AL) amyloidosis 

Supportive Care 


Laboratory Science 


86 LS09 

Profiling dynamics of EBV-specific cytotoxic T-cell 

response in Hodgkin Lymphoma and its implication 

for immunotherapy 

87 LS12 

A phase II trial in patients with previously untreated 

acute promyelocytic leukaemia to evaluate the 

effects of: (i) adding arsenic trioxide to all-trans 

retinoic acid and idarubicin for remission induction, 

and (ii) adding arsenic trioxide to all-trans retinoic 

acid as consolidation 

88 LS13 

Wt-1 expression levels as a marker of Minimal 

Residual Disease (MRD) in AML 

89 LS14 

Immune and viral biomarkers as tools to assist clinical 

outcome in patients with EBV-positive lymphomas 

90 LS15 

Regulatory T-cells in patients with follicular lymphoma 

receiving Rituximab, scientific sub-study to NHL-14 

Trials Closed to Accrual 


96 ALL2 

LALA94 – Multicentre trial of induction and post 

remission therapy of adult acute lymphoblastic 

leukaemia 

96 ALL3 

A phase II study of induction therapy using 

idarubicin and infusional high dose cytarabine 

for adult patients with de novo untreated acute 

lymphoblastic leukaemia 

Contents 

4


(Continued) 

97 AMLM9 

A phase I-II study of idarubicin dose escalation 

in combination with infusional high dose 

cytarabine in patients with untreated adult 

acute myeloid leukaemia 

97 AMLM10 

A phase II study of flexible low intensity combination 

chemotherapy (FLICC) for elderly patients (>60yrs) 

with acute myeloid leukaemia 

98 AMLM11 

Non-myeloablative allogeneic stem cell 

transplantation (NMSCT) in adults with intermediate 

and adverse prognosis AML in first complete 

remission 

98 AMLM12 

A placebo-controlled, randomised trial of the effect 

of palifermin on severe oral mucositis following 

intensive induction chemotherapy incorporating 

high dose cytarabine and a randomised trial 

of idarubicin dose escalation in consolidation 

therapy in patients with untreated adult acute 

myeloid leukaemia 

99 AMLM13 

High dose cytosine arabinoside and fludarabine 

without anthracycline for core binding factor AML 

99 APML3 

A phase II trial of ATRA and intensive idarubicin 

followed by molecular monitoring in patients with 

acute promyelocytic leukaemia 

100 APML4 

Arsenic oxide combined with ATRA and Idarubicin as 

first line therapy for acute promyelocytic leukaemia 

100 CMLALL1 

A phase II pilot study of Glivec (STI571) combined 

with induction chemotherapy in blast-phase chronic 

myeloid leukaemia and Philadelphia chromosomepositive 

acute lymphoblastic leukaemia 

101 MDS3 

A Phase I/II trial of combination therapy with 

5-azacytidine (Vidaza) and Thalidomide in patients 

with Myelodysplastic Syndromes (MDS) 


102 BM02 

Pamidronate post allogeneic bone 

marrow transplantation 



103 CML4 

Pilot study to determine the efficacy and safety 

of Glivec® (STI571) alone and Glivec® (STI571) plus 

Intron A in the early recovery phase post autologous 

blood or marrow transplant for advanced phase 

chronic myeloid leukaemia and Ph-positive acute 

lymphoblastic leukaemia 

103 CML5 

A phase II study of efficacy and safety of Glivec® 

in patients with chronic myeloid leukaemia and 

complete or near complete cytogenetic response 

to interferon-alpha therapy 

104 CML6 

A phase II study in adult patients with newlydiagnosed 

chronic myeloid leukaemia of initial 

intensified Glivec® therapy and sequential therapy 

for non-responders 

104 CML7 

Phase II trial of Pegasys in Glivec® responsive 

chronic myeloid leukaemia 

5



105 HD3 

An ANZLG/TROG prospective study of limited 

chemotherapy and involved field radiotherapy for 

patients with clinical stage I-II Hodgkin disease 

105 HD4 

BEACOPP (4 cycles escalated + 4 cycles baseline) 

versus ABVD (8 cycles) in stage III & IV 

Hodgkin lymphoma 

106 HD9 

Long-term follow-up of Hodgkin Lymphoma survivors: 

An Australian and New Zealand patterns of care study 

106 HDNHL4 

An ALLG/TROG prospective multicentre study 

of involved-field radiotherapy with transplantation 

for patients with Hodgkins disease and 

non-Hodgkin lymphoma 

107 LY02 

A prospective, non-randomised study of chemotherapy 

and radiotherapy for osteolymphoma 

107 LY04 

A phase II study of idarubicin-based combined 

modality therapy in primary central nervous 

system lymphoma 

108 LY05 

A phase II randomised study to assess the reponse 

of fludarabine in combination with cyclophosphamide 

vs fludarabine in combination with cyclophosphamide 

and Mabthera in patients with untreated mantle 

cell lymphoma 

108 LY06 

A clinicopathological study in Burkitt’s and 

Burkitt-Like non-Hodgkin’s lymphoma 

109 NHL07 

Phase III randomised trial of high-dose CEOP 

chemotherapy and Filgrastim versus standard dose 

CEOP in patients with non-Hodgkin’s lymphoma 

109 NHL08 

Trial to evaluate early high dose therapy (HDCT) and 

autologous bone marrow transplantation (ABMT) 

as part of planned initial therapy for poor risk 

intermediate grade non-Hodgkin lymphoma 

110 NHL10 

Randomised intergroup trial of first line treatment 

for patients with diffuse large-cell non-Hodgkin 

lymphoma with a CHOP-like chemotherapy regimen 

with or without the anti-CD20 antibody Rituximab 

(IDEC-C2B8) 

110 NHL11 

A phase II study of a modified ‘Hyper-CVAD’ frontline 

therapy for patients with poor prognosis diffuse 

large B-cell and peripheral T-cell non-Hodgkin 

lymphoma 

111 NHL13 

Randomised study of ICE plus Rituximab (R-ICE) vs 

DHAP plus Rituximab (R-DHAP) in previously treated 

patients with CD20 positive diffuse large B-cell 

lymphoma, eligible for transplantation followed by 

randomised maintenance treatment with Rituximab 

111 NHL18 

A multicentre, randomised Phase III Study 

of Rituximab as maintenance treatment versus 

observation alone in patients with aggressive 

B-cell lymphoma 

112 NHL19 

Follow up observational study of the randomised 

intergroup trial of first line treatment for patients 

with diffuse large B-cell NHL with a CHOP-like 

chemotherapy regimen with or without the 

anit-CD20 antibody Rituximab 

Contents 

6



113 CLL2 

International Phase III-Trial in B-cell CLL. 

Intermediate-dose chlorambucil vs cladribine 

vs fludarabine 

113 LY03 

A randomised trial of chlorambucil vs 

fludarabine as initial therapy of Waldenström’s 

macroglobulinaemia and splenic lymphoma 

with villous lymphocytes 

114 NHL14 

An intergroup randomised trial of rituximab versus 

a watch and wait strategy in patients with advanced 

stage, asymptomatic, non-bulky follicular lymphoma 

(Grades 1, 2 and 3a) 

114 NHL16 

A multicentre, phase III, open-label, randomised 

study in patients with advanced follicular lymphoma 

evaluating the benefit of maintenance therapy 

with Rituximab after induction of response with 

chemotherapy plus Rituximab in comparison 

with no maintenance therapy (PRIMA) 

115 NHLLOW4 

Chimeric anti-CD20 monoclonal antibody (Mabthera) 

in remission induction and maintenance treatment 

of relapsed follicular non-Hodgkin lymphoma: 

a phase III randomised clinical trial – intergroup 

collaborative study (EORTC 20981) 

Myeloma 

116 MM5 

A pilot study of melphalan 220mg/m2 and 

amifostine cytoprotection as conditioning for 

autologous stem cell transplantation in patients 

with multiple myeloma 

116 MM6 

A multicentre randomised phase III study of 

low-dose thalidomide, prednisolone and zoledronic 

acid versus prednisolone and zoledronic acid for 

post-asct maintenance therapy in patients with 

multiple myeloma 

117 MM7 

A multicentre phase II study of the safety and 

efficacy of thalidomide post-allogeneic stem cell/ 

bone marrow transplantation in multiple myeloma 

117 MM8 

A Phase II Study of risk-adapted IV melphalan in 

AL amyloidosis 

118 MM9 

A three-stage phase I/II dose-escalation study 

of high-dose melphalan with palifermin for patients 

with multiple myeloma 


119 SC01 

Multicentre randomised controlled clinical trial 

comparing two strategies for the diagnosis of 

invasive aspergillosis in high-risk haematology 

patients (ASPID study) 

Publications, Presentations 

and Abbreviations 

123 Publications 

132 Meeting Presentations and Abstracts 

142 Abbreviations 

7

A short history of the 

Australasian Leukaemia 


Janey Stone 

The origins of the ALLG go back 38 years 

to when Dr Fred Gunz, who was at that 

time director of the Kanematsu Institute 

at Sydney Hospital, convened a meeting 

of haematologists to discuss the formation 

of a study group to perform studies 

in leukaemia and lymphoma. 

The first meeting was held 

in May 1973 at the Noah 

Motel in Canberra and there 

were nine attendees from 

different parts of Australia: 

Fred Gunz, Bob Pitney, Paul 

Vincent, Barry Way (all from 

Sydney), Ian Cooper, David 

Penington (Melbourne), 

Ed Sage, Richard Kimber 

(Adelaide) and Albert 

Baikie (Hobart). 

Following that initial 

gathering, with the 

involvement of members 

from New Zealand it 

subsequently adopted the 

name of the Australian and 

New Zealand Lymphoma 

Group (ANZLG). 

A pathology review panel 

was also established in the 

first year, with the convenor 

Reg Motteram one of 

Australia’s leading 

anatomical pathologists 

and at the time Director 

of Pathology at Peter 

MacCallum. The other 

members of this original 

panel were Dr Allan Palmer 

(Sydney) and Dr Tom Hanson 

(Adelaide). From the beginning 

Reg was concerned to define 

the quality of the material to 

be provided for histological 

review for trial purposes, 

and in so doing set a standard 

to be followed by later 

participants in the ALLG 

lymphoma pathology review 

panel. Philip Ironside took 

over the leadership of the 

panel in 1979 when Reg 

retired. Reg Motteram 

died in December 2011. 

The protocol for the first 

trial conducted by the ANZLG 

was finalised in 1974. This, 

NHL1, was a randomised 

phase III trial in NHL of COP 

(CVP) vs PEP (teniposide 

substituted for vincristine). 

NHL1 accrued 181 patients 

between 1975 and 1978. 

The trial was presented at 

the COSA ASM in 1979 and 

even received an invitation 

to present at the Lugano 

Conference in 1981. It was 

published in 1982. (Australia 

and New Zealand non-Hodgkin’s 

Lymphoma Cooperative 

Chemotherapy Study Group. 

Chairman IA Cooper. A 

comparison of the use of 

Teniposide and Vincristine 

in combination chemotherapy 

for non-Hodgkin’s lymphoma. 

Cancer Treatment Reports 

1982; 66 (1): 49–55.) 

As early as 1977 the group 

was developing plans for 

a second randomised study. 

NHL2 was even more 

ambitious, being a three 

way comparison comparing 

regimens COP, PEP to which 

adriamycin was added and 

then one in which vincristine 

and teniposide were both 

included, leading to the 

acronyms AVEP, ATEP 

and AVTEP. Interestingly 

Dr Michael Keating, now 

at MD Anderson in the US, 

but then at St Vincent’s 

Hospital in Melbourne, 

assisted in the trial design. 

This trial accrued 74 patients 


By 1982 there were members 

from 12 institutions in 

Australia and New Zealand. 

Follow on trials in NHL 

(NHL3 and NHL4) investigated 

the regimen MATCOP 

(renamed from CATMOP!!). 

Other significant lymphoma 

trials during the 1980s and 

1990s included a randomized 

comparison of CHOP with 

MACOP-B (NHL5) (with Paul 

Klimo from Vancouver 

Hospital participating in the 

discussions), and a Phase III 

high dose CEOP vs standard 

dose chemotherapy in 

aggressive lymphoma 

(NHL7). 

The first international 

collaboration 

occurred in 1987. 

Members of the ANZLG 

contributed patients to 

an NCIC trial of MOPP/ 

ABV hybrid vs MOPP/ABV 

for advanced or recurrent 

Hodgkin’s disease. 

A Short History of ALLG 

8

The developments in ALLG trials throughout its history 

1 

patient trial accrual by diagnosis 

(1974 to 2011) 

2 

patient accrual leukaemia trials 

(1980 to 2011) 

1800 

1600 

1400 

1200 

1000 

800 

600 

400 

200 

0 

74–79 80–84 85–89 90–94 95–99 00–04 05–09 10–11 

700 

600 

500 

400 

300 

200 

100 

0 

80–84 85–89 90–94 95–99 00–04 05–09 10–11 

Total 

Lymphoma 

Acute Leukaemia/MDS 

MM 

Chronic Leukaemia 

Other 

Acute Leukaemia 

MDS 

CML 

CLL 

3 

80 

70 

60 

50 

40 

30 

20 

10 

0 

Acute 

leuk 

PUBLICATIONS AND PRESENTATIONS 

(BY DISEASE) 

NHL 

CML 

CLL 

HD 

MM 

Lymph 

PT 

Supp 

care 

Presentations Publications 

BM 

Lymph 

other 

MDS 

N/A 

1 

2 

3 

Shows trends in trial accrual since the group’s 

inception according to broad diagnostic groupings. 

The steep rise in accrual rates overall during the 

1990s is very apparent. Note that the final time 

period has only two years. 

Shows trends in accrual for Leukaemia trials. It shows 

a steady increase in acute leukaemia patients over the 

time period with CML and MDS accrual entering from 

2000 onwards. Note that the final time period has only 

two years. 

Shows the wide range of diseases in which ALLG 

research has resulted in publications. The most 

productive have been acute leukaemia, NHL and CML. 

9

1 

2 

1 Left to right: Max Wolf, 

Ian Cooper, Surender Juneja, 

Henry Januszewicz 

2 In 1981, the data from the CRFs 

were entered onto punch cards 

and taken by bicycle by Jane 

Matthews to the mainframe 

computer at Melbourne 

University. 

3 First executive following fusion 

– dinner 1999. Back row: 

Max Wolf, Warwick Benson , 

Tim Hughes, Carol Smith. 

Front row: Janey Stone, 

Ken Bradstock, Jeff Szer, 

Kerry Taylor 

4 Max Wolf (Chairman ANZLG) and 

Ken Bradstock (Chairman ALSG) 

shake hands following the vote 

to fuse in May 1999. 

Throughout 20 years, 

Ian Cooper remained the 

guiding force of the ANZLG 

as Chairman as well as 

principal investigator of 

several group trials. Ian 

became ill and then retired 

in 1994; in 1996 we mourned 

his untimely death. Max Wolf 

took over the reins of Chair 

and led the group until fusion 

in 1999. 

The ANZLG discussed 

on several occasions the 

possibility of performing 

leukaemia trials, but the 

financial status of the group 

in the 1970’s was a major 

impediment. In 1982, 

Ray Lowenthal and Paul 

Vincent arranged a separate 

investigators meeting which 

led to the formation of the 

Australian Leukaemia Study 

Group (ALSG). Following 

a pilot study (AMLM1), the 

group set up a phase III 

trial in AML of 73 vs 737 

(addition of etoposide) 

(AMLM2). An innovative 

approach to funding was 

to seek sponsorship from 

Ansett Airways who at the 

time were flying Boeing 

737 planes! The AMLM2 

trial accrued 264 patients 


As well as establishing 

the role of etoposide 

in AML, the ALSG AML 

trials demonstrated that 

incorporating high dose 

cytarabine in induction 

therapy resulted in 

improved leukaemia-free 

survival in AML 

Subsequent leadership of 

ALSG was provided by Jim 

Bishop who was Chair for 

several years, followed by 

Ken Bradstock who took 

over in 1993. In addition to 

several phase II studies, the 

group performed another 

important phase III trial 

which demonstrated the 

advantage of incorporating 

high-dose cytarabine into 

induction chemotherapy 

in improving relapse-free 

survival in AML (737 vs 

HiDAC 37; AML4). The 

publications relating to 

these early trials can be 

seen in the full publication 

list on page 123. 

The ALSG also pioneered 

trials in MDS and myeloma. 

MDS1 (Phase 2 study of 

idarubicin in myelodysplastic 

syndrome) accrued a small 

number of patients in 

1987 and MM1 accrued 

a respectable 74 patients 

in 1987 and 1988. 

In 1999, the two groups 

fused, forming the 

Australasian Leukaemia and 

Lymphoma Group (ALLG) 

with Ken Bradstock as the 

inaugural chairman. The 

group was incorporated, 

an executive was elected by 

members and seven major 

disease sub-committees 

each with its own chair 

were set up. Apart from 

studies in leukaemia and 

lymphoma, the ALLG in 

a relatively short time 

expanded its horizons to 

include research into bone 

marrow transplantation, 

multiple myeloma and 

supportive care. There was 

also increased emphasis 

on translational research 

with the establishment 

of the laboratory scientific 

committee and also the 

Tissue Bank, with its own 

management committee. 

By 1982 there were members 

from 12 institutions in Australia 

and New Zealand. 

A Short History of ALLG 

10

3 4 

From the early days, both 

trials and administration 

were centred in ALLG 

Trial Centre, located in the 

Statistical Centre at Peter 

MacCallum Cancer Centre. 

Jane Matthews was the 

Biostatistician for both 

groups, and then for the 

fused ALLG, until late 2003. 

John Reynolds took over the 

responsibility in that year, 

for nearly 25 years all 

central administration and 

trials were run by Janey 

Stone and Fiona Page and 

later Heather Baxter. Only 

in 2002 did the number 

of ALLG Trial Coordinators 

start to grow, when Dr Juliana 

Di Iulio commenced. 

The ANZLG formed the first 

independent trial review 

panel in 1988 for the NHL5 

study. It was headed by Dr 

F W Gunz (Haematologist) 

with Dr Alan Coates 

(Oncologist) and Dr Richard 

Fisher (Statistician) as 

members. This body was 

specific to that trial and 

ceased functioning once the 

trial was completed. In the 

period after fusion, the need 

for independent trial review 

became more pressing. 

With the limited resources 

in Australia it was clear that 

the best strategy was to 

create an overarching body 

responsible for all group 

trials. The ALLG Safety and 

Data Monitoring Committee 

commenced activities on 

1 November 2002 with a 

teleconference. The first 

Chair was Phil Rowlings and 

other committee members 

included Graham Young, 

Judy Simpson, Martin 

Stockler, John Stubbs and 

Jane Matthews. 

In 2005, success in obtaining 

an NHMRC infrastructure 

enabling grant. This 

independent funding 

underwrote a number of 

important developments, 

which now seem such 

an integral part of the 

group that we can hardly 

imagine it without them. 

This included support for 

translational research 

(via a position at the Tissue 

Bank), support for training 

and professional development 

programs and for the SDMC. 

One successful grant provides 

the basis for others, and this 

first funding was followed 

by an NHMRC enabling grant 

for the Tissue Bank, grant 

funding from a variety of 

government bodies such as 

the Victorian Cancer Agency 

and Cancer Australia and from 

the Leukaemia Foundation 

and others. The improved 

financial situation allowed 

the establishment of a clearly 

defined Operations Unit and 

new or improved processes 

to support the group’s activities. 

The training program, the 

regional support activities, 

264 

patients 

and many other of the group’s 

services to support members 

and site trial participation 

all date from the changes 

in financial support that 

occurred within the last 

five or so years. 

The older ways of conducting 

group affairs, relying on the 

spare time of a few dedicated 

individuals and loose 

structures and networks 

clearly needed a major 

overhaul. Following an 

extended process of review 

and discussion, 2010 saw 

a new constitution and 

a new structure of the group. 

The last decade has 

witnessed extensive changes 

which have resulted in the 

establishment of a wellstructured 

co-operative 

trials group, with leadership 

from experienced clinical 

and laboratory researchers, 

a professional Operations 

Unit and governance from 

a Board of Directors. There 

are many ongoing clinical 

AMLM2 

trial accrual 

between 1984 

and 1986 

trials in a wide range of 

haematological malignancies. 

The group’s international 

reputation is now very 

well established and 

participation in international 

trials is a feature of the 

trial portfolio. 

We can be proud that our 

trials have contributed to 

what are now standard 

treatments in Australia and 

New Zealand in AML and 

other conditions, and our 

contribution to important 

international trials. The 

triallists of the past worked 

with almost no resources 

and that they achieved 

so much is remarkable. 

11

Chairman’s Report 

It is my very great pleasure to present 

my Chairman’s Report for 2011 on behalf 

of the Board. 

The newly constituted Board of ALLG has 

achieved a great deal in its first full year. 

Peter T. Kempen 

Chairman 

My fellow Board members 

are Peter Bardy, Geraldine 

Gray, Mark Hertzberg, 

Malcolm McComas, John 

Mortimore, Andrew Roberts 

and Andrew Spencer. 

When the change in the 

ALLG governance structure 

was proposed and adopted 

it was envisaged that ALLG 

would appoint a CEO 

to oversee the day to day 

activities of the organization. 

On 1 July of this year the 

Board appointed Delaine 

Smith to that role and 

I would like to formally 

congratulate her 

on her appointment. 

Another important staff 

appointment was that of 

Beth Schofield as Business 

Manager at the beginning 

of the year. Beth has taken 

charge of the ALLG finances 

and has provided strong 

business support to Delaine 

and the Board. 

The Board approved the 

ALLG Strategic Plan 

2010–2016 document, 

which outlines our 

progressive goals and 

objectives toward clinical 

trial research. A copy was 

sent to each member and 

is also available on the ALLG 

website. The management 

team is periodically 

Cancer Austrlia has 

agreed to continue 

its funding until 

30 June 2013. 

reporting to 

the Board on the progress 

of each of our objectives. 

I would like to thank those 

who provided input to the 

plan which has been very 

helpful. I would also 

encourage any member 

to provide input for future 

consideration where the 

organization could be 

further enhanced. 

Cancer Australia provides 

ALLG funding to assist in 

meeting the costs of our 

infrastructure. The grant 

has historically been for 

a three year period and 

I am pleased to advise that 

Cancer Australia has agreed 

to continue its funding until 

30 June 2013. 

Our very successful Tissue 

Bank has in substantial part 

been funded by an Enabling 

Grant from the NHMRC. The 

Enabling Grants are being 

phased out and our funding 

was to end at 30 June 2011, 

although the government 

agreed to extend funding 

until March 2012 pending 

a review of the special 

circumstances of our 

Tissue Bank. 

At the date of writing this 

report, we do not have any 

positive indications that 

the Federal Government 

will provide any further 

funding for our Tissue Bank 

beyond 31 March 2012 and 

as a result we are seeking 

alternative sources of 

funding to help overcome 

the likely funding shortfall. 


12

We continue to receive 

strong support from 

Leukaemia Foundation 

Australia which also has a 

vital interest in the outcome. 

The Board is 

committed to 

maintaining our 

Tissue Bank and 

will leave no stone 

unturned in the 

pursuit of that 

objective. 

I would like to pay tribute 

to Paula Marlton, the Director 

of the Tissue Bank, for her 

tireless work on this very 

critical issue. 

Apart from the funding 

of the Tissue Bank, the 

termination by the Federal 

Government of the “Boost 

Program” which supported 

our regional sites was 

extremely disappointing. 

This was a program 

initiated by the Government 

three years ago and its 

termination has had a 

significant and detrimental 

impact on our clinical trials 

within regional hospitals. 

The ALLG will continue 

to identify ways in which 

support can be directed 

to regional sites so as to 

allow inclusion of regional 

participants in CT’s. 

The Marketing Committee of 

the Board (which includes 

Board members John 

Mortimore as Chair and 

Geraldine Gray) has finalised 

a Marketing Plan which is 

aimed at publicizing the 

activities of ALLG and its 

members to better inform 

Governments, the community 

and potential donors of 

the benefits of our clinical 

trials. The Committee also 

includes our consumer 

representatives (Anne 

Hodgson and Sandra 

Slatter) who have made 

a very valuable contribution 

to its deliberations. 

The ALLG was granted 

Deductible Gift Recipient 

status immediately after 

the General Meeting in 

May 2011 which approved 

an amendment to the 

Constitution. 

In the short time available 

to the end of the financial 

year, we received $40,000 

in donations to support 

our work. 

We are now able to seek 

donations from major 

corporate donors and 

philanthropic trusts and 

we have started making 

applications to these bodies. 

I am pleased to advise 

that in December 2011 

a philanthropic trust 

approved a substantial 

contribution to one of our 

clinical trials which was 

DONATIONS 

$40K 

at the end 

of FY 2011 

We are now able to 

seek donations from 

major corporate donors 

and philanthropic trusts 

and we have started 

making applications 

to these bodies. 

13

activated during the year. 

With our newly won status, 

I also anticipate that we will 

see the benefits of the work 

of the Marketing Committee 

as the year unfolds. 

Over the years ALLG has 

enjoyed a very strong 

relationship with Peter 

MacCallum Cancer Centre 

(PMCC) and in particular its 

BaCT unit. It has provided 

us with a range of services 

which have facilitated 

our clinical trials as well 

as assistance with our 

infrastructure. 

During the year we have 

had some very fruitful 

discussions with the 

management team at PMCC 

and our infrastructure 

arrangements will be 

changed. 

To eliminate a potential 

conflict between BaCT’s 

role in providing services 

to ALLG in relation to clinical 

trials and its responsibilities 

for our staff. 

Our financial position is 

overseen by the Financial 

and Audit Committee ably 

chaired by Board Member, 

Malcolm McComas 

and supported by the 

Business Manager. 

Notwithstanding the many 

financial challenges that 

face ALLG, I am pleased 

to note that the financial 

statements for the year 

ended 30 June 2011 indicate 

that the organization is in 

a healthy financial position. 

This was the first year of 

elections under our new 

Constitution. I am pleased 

to note that Andrew Roberts 

and I stood for re-election 

to the Board in November 

and that we were both 

unanimously supported 

by the members. 

I would also like to 

congratulate Maher Gandhi 

and Ken Romeril who were 

elected to the SAC and 

thank them for putting 

themselves forward. 

I would like to 

acknowledge the 

endless amount of time 

the members give to 

drive and support each 

other in the pursuit of 

excellence in research. 

I would like to pay tribute 

to the role that Mark 

Hertzberg has played 

as Chair of the Scientific 

Advisory Committee and 

as a Board member. As 

Chair of the SAC, Mark 

is integral to many of the 

operational decisions, 

and his commitment to 

the work of ALLG is truly 

outstanding and his advice 

is highly valued. 

ALLG is very lucky 

to have a team 

of professionals 

who are dedicated 

to its activities. 

Ably led by Delaine Smith 

as CEO and supported by 

Beth Schofield (Business 

Manager), Melissa Benedict 

(Quality and Grants), Megan 

Sanders and Cristina 

Conesa-Anghel (Protocol 

Development), Janey Stone 

(Special Projects) and Dilu 

Uduwela (Administration 

and Events). Not forgetting 

of course our Tissue Bank 

team, led by its manager 

Megan Ellis. 

On behalf of the Board and 

the membership, I would 

like to thank all of the team 

for their individual and 

collective contributions 

to what has been another 

productive year. 

I would like to acknowledge 

the endless amount of time 

the members give to drive 

and support each other 

in the pursuit of excellence 

in research. I continue 

to be impressed by the 

commitment and collegiate 

nature of the membership. 

I would also like to 

acknowledge the pro bono 

support to the ALLG from 

the following organisations: 

Clayton Utz, MinterEllison, 

Aon Risk Services Australia 

Limited, Lab Cabs Australia; 

and the companies that 

support the Tissue Bank 

and those companies, 

organisations and institutes 

that provide trial 

specific support. 

We look forward to continuing 

to building strong relations 

for the successful future 

of the ALLG clinical trial 

program. 

In closing, I would like 

to thank my fellow Board 

members for their support. 

The Board continues to 

work harmoniously as 

a cohesive team with each 

member bringing their skills 

and experience to bear 

as required. I think we can 

look forward to another 

successful year. 

Peter T. Kempen 

ALLG Chairman 


14

SAC Report: Mark Hertzberg 

It was with both a degree of apprehension 

and enthusiasm that I accepted the 

role of Chair of the ALLG Scientific 

Advisory Committee, taking over 

from John Seymour. 

Mark Hertzberg 

Chairman 

It is not an 

overstatement 

to say that much 

of the current 

favourable position 

of the ALLG is due 

to John’s substantial 

contributions over 

an extended period 

of time including 

the last 5 and half 

years as Chair. 

John has worked tirelessly 

in guiding the ALLG through 

the most important structural 

reform in its history with 

the establishment of its 

new professional structure 

including the ALLG Board 

headed by Peter Kempen, 

and the ALLG Operations 

Office headed by our new 

CEO Delaine Smith. As we 

all only too well aware, John 

has an extraordinary capacity 

for work, and his wisdom 

and perception have been 

instrumental in enabling 

the ALLG to achieve this 

new era of organisational 

maturity. It is to his credit 

that his contributions 

in Haematology were 

recently acknowledged 

by the presentation of the 

prestigious Distinguished 

Alumnus Award at the 

MD Anderson Faculty 

Honors Convocation 

in Houston Texas. 

SAC 

Membership 


all the members of the 

SAC who have contributed 

substantially to the conduct 

and oversight of our clinical 

trial portfolio, particularly in 

their capacities as Disease 

Group Chairs. They include 

Pauline Warburton, David 

Ritchie, Stephen Mulligan, 

Con Tam, Ian Lewis, and 

Andrew Wei. On behalf of all 

the members I would like to 

thank recently retiring SAC 

members Joy Ho and Tony 

Mills, each of whom has 

made a major contribution 

during their tenure on the 

SAC. Joy first joined the 

Executive in 2005 and was 

active not only as Chair 

for the Laboratory Science 

Committee for more than 

5 years, but also for 2 years 

as Treasurer as well as 

co-Chair of the Low Grade 

Lymphoma/Multiple Myeloma 

Disease Group. Tony has 

been a member of the SAC 

for 2 years, and served as 

a highly effective Chair 

of the CML/MPD Disease 

Group and SAC Liaison 

to the SDMC. 

A/Prof Maher Gandhi and 

Dr Ken Romeril have been 

elected to the committee 

as of November 2011. 

Maher is one of the 

leading researchers in 

Lymphoma in Australia, 

and is the new Chair for 

the Laboratory Sciences 

Committee. Ken Romeril 

from Wellington Hospital 

is the representative from 

New Zealand and has been 

Chair of the NZ Leukaemia 

Study Group. The SAC is 

15

also planning to ensure that 

entry of new members is 

balanced against retaining 

experienced members. 

The membership rotation 

is being reviewed so that 

terms can be staggered 

over the coming years. 

ALLG 

Operations 

Office and 

ALLG Board 

The ALLG has 

moved into 

a new era of 

professionalism. 

Delaine Smith is our new 

Chief Executive Officer 

and her diligence, skill set, 

and attributes have helped 

establish the ALLG Office as 

one of the most proficient 

and productive among all the 

cancer co-operative trial 

operations in Australia. In 

the Office, we are fortunate 

to have such a highly capable 

and adept Business Manager, 

Beth Schofield. In addition, 


the enormous contributions 

made by Dilu Uduwela in 

Administration and Events, 

Melissa Benedict tackling 

Quality, Education and Grants, 

Janey Stone in Special 

Projects and Megan Sanders 

as Protocol Development 

officer. I would like to thank 

Cristina Conesa-Anghel who 

ably fulfilled the protocol 

The future of the ALLG is particularly 

dependent on two things: that is, 

robust clinical research and fiscal 

business practice. 

development officer role 

over the last year. 

The establishment of the 

Board has been one of the 

most significant and fruitful 

advances in the history of 

the ALLG. Peter Kempen 

has been an extraordinarily 

effective Chairman of the 

ALLG Board, which continues 

to provide wisdom and 

sound strategic and financial 

oversight of the ALLG, as well 

promoting the cause, profile, 

and impact of the ALLG in 

the wider community and 

political arena. 

SAC Priorities 

The future of the ALLG is 

particularly dependent on 

two things: that is, robust 

clinical research and fiscal 

business practice. The SAC 

will play the crucial role 

in extending the range of 

our research activities. 

Accordingly, a few of the 

priorities for the next few 

years include: 

1. Disease Group 

Committee 

The strategic oversight 

of our clinical trials is 

undertaken by the 

various Disease Group 

Committees. Each DGC 

has been expanded 

to include 8 to 10 

members, and is lead 

by a Chair from within 

the SAC. It is hoped 

that the role and 

contribution of each 

of these disease groups 

can be strengthened by 

engaging other ALLG 

members in their trial 

activities. Moreover, 

new and existing 

ALLG members are 

encouraged to join any 

of the DGCs at any time. 

New endeavours are 

currently underway 

within the DGCs. 

Each of the DGCs is 

now holding at least 

two teleconferences 

throughout the year to 

explore potential future 

trial opportunities. 

For example, The 

Acute Leukaemia/ 

Myelodysplasia Disease 

Group is focussing on 

the common study 

entry process for AML 

proposed by Andrew 

Wei. The purpose is 

to ensure all potential 

trial participants are 

uniformly screened and 

essential diagnostic, 

cytogenetic and 

molecular markers 

are collected including 

TB samples. Patients 

can then be offered the 

trial for which they 

are eligible. 

2. Global research 

Members are the 

backbone of the ALLG, 

and many have the 

opportunities to access 

and maintain valuable 

international relations 

with individual 

investigator colleagues 

and co-operative groups 

in Europe and North 

America. I would 

like to develop and 

enhance formal 

partnerships with our 

cooperative group 

counterparts, such 

as via representation 

on international 

committees, and 

invitations to attend 

SAC Chairman’s Report 

16

ALLG meetings, and in 

particular to extend this 

to our Asian affiliates. 

3. SAC support 

The SAC endeavours to 

support the Board and 

members to implement 

the Strategic Plan and 

to develop priorities 

and procedures to meet 

future challenges, such 

as the introduction 

of new systems 

capabilities and 

expansion of the 

ALLG trial portfolio. 

4. Central function 

of the SAC 

A central function of the 

SAC is to oversee all our 

clinical trial portfolio, 

including those in 

development and those 

currently accruing. 

We have 19 active clinical 

trials in progress 

including 8 phase III 

randomised studies. 

In 2011, publications 

reached 10, and 

presentations were 

18 at international 

conferences. To assist 

local and principal 

investigators, a detailed 

publication policy for 

the group is being 

drafted in 2012. 

5. Correlative 

research 

proposals 

Correlative research 

proposals are critically 

linked to our clinical 

trials, and inclusiveness 

of our scientific 

colleagues is crucial 

for our sustainability 

and growth. A critical 

component of this 

research is exemplified 

by the ALLG Tissue Bank 

which provides a pivotal 

resource underpinning 

our scientific research 

endeavours. Since the 

NHMRC Enabling Grants 

are being phased out, our 

TB funding is only secure 

until early 2012, pending 

a further NHRMC review 

of cancer Tissue Banks. 

The Board has committed 

to the ongoing viability 

of the TB and is seeking 

alternative funding 

sources in addition to the 

recurrent commitment 

from the Leukaemia 

Foundation. 

Seed funding 

for new trial 

development 

The Board has approved 

an exciting new program to 

encourage the development 

of new trial proposals. 

A substantial amount will 

be allocated annually 

as discretionary funding 

to be available to the SAC 

to allocate as seeding. The 

intention of discretionary 

funding is to support the 

ALLG clinical trial program. 

Utilisation of seed funding 

will allow the SAC to support 

timely and continuous 

research work. 

Since this is seed funding, 

the applicant will need to 

provide details of where 

other funding sources are 

being pursued and an 

expected timeframe. The 

ALLG operations office will 

provide advice and support 

to individual investigators 

in their applications. 

Submissions will be made 

via the Disease Group 

Chairs and each committee 

will in turn prioritise those 

applications. DGC Chairs will 

then submit their preferred 

application(s) to the SAC 

which will review and score 

all proposals and select 

the most appropriate for 

funding under the scheme. 

Any amount not used in 

one year will carry over 

to the next. 

Finally, as I undertake 

regular reporting to the 

Board, I will continue 

communications to the 

members via the Scientific 

Meetings and newsletter 

correspondence. 

I look forward to 

pursuing the interest 

of the members to 

achieve collaborative 

research excellence. 

Prof Mark Hertzberg 

SAC Chairman 

17

ALLG Scientific Advisory 

Committee (SAC) 

The SAC is a subcommittee 

reporting directly to the 

ALLG Board. The members 

of the SAC are voted from 

within the Membership 

and each elected member 

serves a term of 3 years, 

with the option to serve 

a second term of 3 years 

in line with the Constitution, 

section 15. 

The SAC is specifically 

responsible for the 

scientific direction of the 

ALLG; scientific scrutiny, 

prioritisation, peer review 

and support to fellow 

members. The SAC provides 

the necessary approval of 

all new trials and assists 

Principal Investigators with 

development, conduct and 

reporting of clinical trials. 

Purpose of SAC 

To co-ordinate, plan and 

lead the ALLG’s effort in 

conducting research into 

the causes, biology and 

treatment of leukaemia, 

lymphoma and related 

blood diseases. 

Responsibilities 

• Scientific assessments 

of and relating to each 

Study 

• Review of the scientific 

elements of the 

Protocols 

• Determination of the 

scientific direction 

and priorities of the 

Company 

• Co-ordinate the 

establishment of 

Disease Group 

Committees (DGC), 

which actively supports 

members and Principal 

Investigators (PIs). 

In 2011 the ALLG 

membership were proudly 

represented by the following 

SAC Committee: 

Chair 


Westmead Hospital 

Sydney, NSW 

Vice Chair 

Dr Pauline Warburton 

Wollongong Hospital 

Wollongong, NSW 

Committee 

members 

A/Prof Maher Gandhi 

(Newly Elected in 

November 2011) 

Princess Alexandra Hospital 

Brisbane, QLD 

A/Prof Phoebe Joy Ho 

(January – June 2011) 

Royal Prince Alfred Hospital 

Camperdown, NSW 

A/Prof Ian Lewis 

Royal Adelaide Hospital 

Adelaide, SA 

Dr Anthony Mills 

(January – November 2011) 

Princess Alexandra Hospital 

Brisbane, QLD 

A/Prof Stephen Mulligan 

Royal North Shore Hospital 

Sydney, NSW 

A/Prof David Ritchie 

Peter MacCallum 

Cancer Centre 

Melbourne, VIC 

Dr Kenneth Romeril 

(Newly Elected in 

November 2011) 

Wellington Hospital 

Wellington, New Zealand 

Prof John Seymour 

Peter MacCallum 

Cancer Centre 


Dr Constantine Tam 

St Vincent’s Hospital 


Dr Andrew Wei 

Alfred Hospital 


Disease Group 

Committees 

(dgcs) of the 

Scientific Advisory 

Committee (sac) 

The primary aim of the 

Disease Group Committees 

(DGCs) is to develop, prioritise, 

promote and co-ordinate 

high-quality clinical and 

translational research in 

specific disciplines. The 

number and disciplines 

of DGCs may change from 

time to time. 

The DGC functions 

include: 

1. Ensure broad input and 

participation to the DGC 

by ALLG Members 

2. Generate and lead 

scientific discussion 

and robust ideas for 

research 

3. The DGC Chair should 

lead the review of 

all trials within their 

disease group 

4. The DGC needs to be 

sustainable to achieve 

the group’s objectives, 

this may be via the 

conduct of meetings 

(teleconference or 

face-to-face) with the 

aim to generate new 

ideas, and share the 

progress of current 

studies, and discuss 

possible international 

collaborations. The 

meetings should also 

include review of the 

current trials authorship 

and publication intentions. 

SAC Report 

18

Disease Group Committees 


(All, Aml & Mds) 

Disease Group Chairs 

Dr Andrew Wei 


Committee Members 

Ken Bradstock 

Uwe Hahn 

Luciano Dalla-Pozza 

Devendra Hiwase 

Michael Dickinson 

Harry Iland 

James Gray 

Andrew Lim 

Andrew Grigg 

Paula Marlton 

Bone Marrow Transplant (bmt) 



A/Prof Ian Lewis 


Sharon Avery 

John Moore 

Ashish Bajel 

Sushrut Patil 

Leanne Berkahn 

Anthony Schwarer 

Ken Bradstock 

Jeff Szer 

Julian Cooney 

Patricia Walker 


Agnes Yong 

Glen Kennedy 

Chronic Myeloid Leukaemia and 

Myeloproliferative Neoplasms (Cml & Md) 

Disease Group Chair 



Ashish Bajel 

Timothy Hughes 

Cecily Forsyth 

Steven Lane 

Andrew Grigg 

David Ross 

Simon He 



Stephen Ting 

High Grade Non-Hodgkin Lymphoma and 

Hodgkin Lymphoma (Hg Nhl & Hl) 





Peter Mollee 

Geoff Chong 

Dipti Talaulikar 


Judith Trotman 

Uwe Hahn 

Andrew Wirth 

David Ma 

Max Wolf 





Peter Browett 

Paula Marlton 

Lynda Campbell 

David Ritchie 

David Curtis 

Andrew Roberts 

Megan Ellis 

Andrew Spencer 

Anoop Enjeti 

Annabel Tuckfield 

Joy Ho 

Andrew Wei 

Samar Issa 

David Westerman 

Bryone Kuss 

Deborah White 

David Ma 

Low Grade Non-Hodgkin Lymphoma, Chronic 

Lymphocytic Leukaemia (Lg Nhl & Cll) 


A/Prof Stephen Mulligan Dr Pauline Warburton 


Duncan Carradice 

John Seymour 

Bryone Kuss 

Constantine Tam 

Kylie Mason 


Myeloma (mm) 




Hilary Blacklock 

Laurie Catley 

James D’Rozario 

Anoop Enjeti 

Liam Fernyhough 

Simon Harrison 


Joy Ho 





Sharon Avery 

Peter Bardy 


Noemi Horvath 

Ian Kerridge 

Cindy Lee 


Miles Prince 

Ken Romeril 




19

Finance Report for the 

FY ended 30 June 2011 

The ALLG continued to operate within its 

target financial parameters for the financial 

year ended 30 June 2011 (FY2011), with the 

organisation reporting a modest surplus of 

$12,819 in its statutory accounts for the year. 


Chair 

FY2011 financial 

performance 

As part of the 2011 year 

end reporting process 

and analysis of results, 

a number of items were 

identified for which the 

actual result was different 

to that which was subject to 

estimates and judgements 

made in the prior financial 

year. The total amount of 

such items was $196,367. 

Had these items been 

accounted for in the prior 

financial year (FY2010), the 

surplus for FY2011 would 

have been $209,186. 

This is another good result 

for the ALLG and is above 

our projected budget deficit 

for the year of $94,445. 

This result allows ALLG to 

continue to build financial 

reserves with net assets 

increasing marginally to 

$3.16m and cash reserves 

increasing 24% from 

$3.10m to $3.85m. 

Budgeted 

FY2012 

financial 

performance 

For the current 2012 

financial year the organisation 

is budgeting for a deficit 

of approximately $120,000. 

This includes a significant 

contingency for funding 

part of the operational 

expenditure of the 

Leukaemia & Lymphoma 

Tissue Bank in the event 

of further uncertainly over 

future NHMRC funding for 

this important resource. 

Trial seed 

funding reserve 

The surpluses generated 

by the ALLG over preceding 

years enabled the Directors 

to resolve on 27 May 2011 

to establish a Trial Seed 

Funding Reserve. This 

reserve is intended to 

be used to enhance the 

ALLG’s ability to generate 

and support its new trial 

development pipeline and 

grow its research portfolio. 

The reserve is to be applied 

as seed funding to help 

establish new clinical 

research projects where 

such funding is otherwise 

unavailable, or the timing 

of securing such funding 

would cause detrimental 

delays to the progress of the 

research. The allocation of 

funding from the reserve is 

regulated by a set of criteria 

established and governed 

by the ALLG’s Scientific 

Advisory Committee and 

the Board. 

At the commencement of 

the 2011 financial year, the 

Board allocated an amount 

of $200,000 for seed 

funding purposes. Of this 

amount, a total of $54,000 

was granted by the SAC for 

the funding of three clinical 

trials. The unused amount 

of $146,000 as at 30 June 

2011 has been transferred 

Finance Report 

20

2011 

Highlights 

to a separate reserve and 

preserved for future seed 

funding purposes. We look 

forward to seeing these 

funds put to good use 

in the coming years. 

Finance & Audit 

Committee 

The FAC met four times 

during the financial year 

and work included reviews 

of cash flow and financial 

controls, business and 

operational risk, quarterly 

management accounts, 

statutory accounts, new 

clinical trial budgets 

and monitoring financial 

developments in the existing 

trial program. 

Additionally, one notable 

achievement for the 

financial year was the 

passing of a special 

resolution at a meeting of 

members on 5 May 2011 

to make amendments to 

the constitution in order 

to facilitate an application 

to the Australian Taxation 

Office for Deductible Gift 

Recipient Status for the 

Company which was 

subsequently granted 

by the ATO, retrospectively 

from 1 July 2000. 

I would also like to take 

this opportunity to thank 

the members who have 

served on the Finance 

and Audit Committee for 

their time, expertise and 

commitment over the past 

year. The FAC members 

are Peter Kempen, Prof 

Mark Hertzberg, Dr 

Judith Trotman, Prof John 

Seymour and myself. In 

December 2011, Prof John 

Seymour stepped down 

from the FAC and we 

thank him for his insight, 

experience and long service. 

In particular I would 

like to acknowledge the 

exceptional work of the 

ALLG BM, Beth Schofield. 

The meticulous attention 

to the detail of the clinical 

trial budgets is evident, 

and the ALLG’s confident 

position is a result of Beth’s 

industrious work with the 

investigators, industry and 

other collaborators. 


Chairman 

ALLG Finance and 

Audit Committee 

SURPLUS 

2011 

$12,819 

NET ASSETS 

2011 

$3.16M 

Cash reserves 

24% 

increase 

from $3.10M 

to $3.85M 

21

Operations Office 

Report 

Delaine Smith 


From its inception, the ALLG has succeeded 

in designing and conducting high impact 

clinical trials in Haematology. Now in 2011, 

we can report a year of equivalent success 

in our governance and operational 

management of the company. 

Times have never been 

better for the ALLG 

Operations Office; we 

have retained our HQ in 

Melbourne, and remain 

more accessible than 

ever to our Members 

via consistent staff with 

clearly delineated roles. 

During the last year 

we saw a great advance 

with the introduction 

of a formal CEO position 

to the company. This is 

highly significant since 

it not only consolidates 

the internal structure of 

the ALLG, but also will 

enhance future ALLG 

interactions in the political 

and international research 

arenas. I am very proud 

of this appointment, but 

equally aware of the 

challenges ahead that this 

provides the ALLG. 

The Board of Directors has 

a real connection with the 

operations of the ALLG. 

While we are fortunate 

in having expert clinician 

Directors, we are privileged 

to have Directors from the 

corporate world who are 

now actively advocating on 

behalf of the ALLG to state 

and federal government 

bodies, and to the 

broader lay and business 

communities. For example, 

the ALLG is now listed with 

numerous philanthropic 

and community groups as 

an initial means of raising 

our profile to enhance 

our donation and grant 

prospects. Allied to this is 

the fact that the ALLG is 

routinely making a number 

of submissions to a diversity 

of government health and 

research initiatives. 

In the last year, the ongoing 

viability of the ALLG Tissue 

Bank (TB) has remained our 

primary focus of concern. 

Following the cessation 

of the NHMRC Enabling 

Grants Scheme, the ALLG is 

confronting a dire unfunded 

crisis for the TB facility. We 

have spent 2011 actively 

lobbying Federal Health and 

Science Ministers, actively 

addressing the NHMRC, 

attending numerous 

government forums, and 

approaching a diverse range 

of funding agencies for 

grants or donations. 

The uniqueness 

and success of our 

current and future 

clinical trial portfolio 

is highly dependent 

on the maintenance 

and viability of our 

Tissue Bank. 

Currently, the ALLG Board 

is pursuing a number of 

potential initiatives as a 

means of securing that 

viability. Either way, the 

Board is committed to 

maintenance of the Tissue 

Bank in whatever form is 

practicable and sustainable. 

Operations Office Report 

22

The three core 

Committees of the 

ALLG Board have 

begun to succeed 

in their own standalone 

conduct. 

1. The Finance and Audit 

Committee (FAC) has 

been exemplified by the 

tremendous leadership 

of Malcolm McComas 

and Beth Schofield. 

Great milestones in 

policy and accounting 

have been achieved 

that have given the 

financial year a healthy 

outlook, which in turn 

provides confidence 

to the members and 

investigators that 

each of the trials 

is financially managed 

in a rigorous manner. 

2. The Scientific Advisory 

Committee (SAC) is 

truly now what it has 

strived to be for many 

many years. The SAC, 

soundly led by Mark 

Hertzberg, has been 

able to spend the year 

focused solely on the 

clinical trial portfolio 

and its underpinning 

with robust clinical and 

laboratory research. 

SAC conduct, policy 

and procedure, 

have been formally 

documented, along with 

implementation of the 

‘seed funding’ program 

initiative. Further to this 

the individual Disease 

Group Committee (DGC) 

Chairs commenced 

group meetings to better 

determine the focus of 

their research priorities. 

3. The Marketing 

Committee was 

established in 2011 and 

led by John Mortimore, 

it has now evolved with 

clearer objectives for 

pursuit of activities 

to market the ALLG 

and expand into the 

area of donations 

and fundraising. With 

many ideas still in 

development, I remain 

optimistic that we will 

see a successful 2012 

with regard to the 

ALLG’s profile. 

Pivotal to ALLG 

is a successful 

clinical trials 

program. This 

success is 

contributed to 

in a number of 

measurable ways: 

1. Development 

portfolio: 

Having a broad scope of 

concepts in various stages 

of maturity is crucial 

to the future of the ALLG. 

The protocol development 

portfolio is ably led by Dr 

Megan Sanders, who works 

closely with the SAC and 

member investigators to 

undertake review of all new 

ideas, progress concepts 

with firm statistical advice 

and feasibility testing, and 

steer the protocols through 

the meticulous review 

processes of the ALLG’s 

Safety and Data Monitoring 

Committee (SDMC). 

As the only Australasian 

haematology oncology 

cooperative clinical trials 

group we are highly 

sensitive to the sometimes 

restrictive research 

environment, and are thus 

dedicated to support all our 

member investigators in 

their research proposals. 

2. Education 

and Training: 

Having the means to 

provide funding assistance 

for clinical trial research 

training is essential. 

Dr Melissa Benedict is 

competently addressing this 

matter, and during 2011 

undertook a major review 

via surveying of Members. 

Your feedback indicated that 

educational opportunity is 

vital, and that a means to 

financially support these 

programs is essential. 

As a result Melissa has 

successfully secured funding 

relationships 

with industry and has made 

considerable inroads 

with philanthropists and 

foundations as future 

possible sources of support. 

In the last year, the ongoing 

viability of the ALLG Tissue 

Bank (TB) has remained our 

primary focus of concern. 

23

3. Scientific 

Meetings: 

Our biannual scientific 

meetings are seamlessly 

organised and conducted 

by Dilu Uduwela. These 

meetings are essential for 

you our Members and for 

us in the Operations Office. 

They are the only means 

available for face-to-face 

clinical trial interactions, 

and we are grateful of 

the valued sponsorship 

of the many companies 

involved with ALLG trials 

and research that enable 

these meetings to occur. 

We again thank our hotel 

partners: Hilton on the 

Park Melbourne (May 

scientific meeting) and 

Hilton Brisbane (November 

scientific meeting) for their 

consistently good service 

that enables us to conduct 

such successful meetings. 

4. Special Projects: 

A degree of flexibility with 

project development has 

proven to be ideal for us in 

the management of realtime 

research issues. Janey 

Stone continues to remain 

key to the ALLG’s ability in 

actioning with its Members 

new initiatives such as the 

central cytogenetics review, 

AML registry development, 

publication highlights via 

the quarterly newsletter, 

and progress with an 

internal trial data program. 

Of special note I would like to thank 

our Chairman, Mr Peter T Kempen, 

for his insightful guidance, our 

company is typified by your 

wonderful leadership. 

I would personally like 

to thank each ALLG 

staff member for their 

commitment to fulfilling 

their role to its highest 

order: Melissa Benedict, 

Megan Sanders and Cristina 

Conesa-Anghel (maternity 

relief), Beth Schofield, Janey 

Stone and Dilu Uduwela. 

The ALLG, in 2011, 

opened a range 

of New Trials: 

• ALL6 – the long awaited 

study for the treatment 

of adolescent and young 

adult ALL. 

• AMLM15 – looking 

at Lenalidomide 

maintenance in AML. 

• MM13 – an international 

trial that we are 

fortunate to participate 

in for patients with 

Amyloidosis. 

Toward the end of the year 

a flurry of activity with the 

SDMC resulted in a number 

trials reaching approval 

status, but will activate at 

sites in 2012: 

• SC03 – a study 

investigating 

Chemotherapy Induced 

Nausea and Vomiting 

(CINV) in patients 

with NHL undergoing 

chemotherapy. 

• AMLM16 – a double 

blinded randomised 

study assessing the use 

of novel agent ‘Sorafenib’ 

in combination with 

chemotherapy for AML. 

I congratulate the protocol 

writing teams, including the 

statisticians who have had 

significant input to all of 

these new studies. 

The ALLG is appreciative 

of the meticulous work 

performed by the trial 

coordinators at our main 

trial centres: BaCT PMCC, 

the Alfred Hospital in 

Melbourne, and RAH/IMVS 

in Adelaide. No fewer than 

20 personnel are attached 

to BaCT providing services 

for statistical design, 

database creations, site 

coordination and regulatory 

reporting. They are the vital 

element in keeping the trial 

program going, and their 

work in producing interim 

and final reports that add 

to our exemplary publication 

listing is noteworthy. 

Of special note I would like 

to thank our Chairman, 

Mr Peter T Kempen, for 

his insightful guidance, 

our company is typified by 

your wonderful leadership. 

It is my great pleasure 

to welcome you on behalf 

of the Operations office to 

the 2011 Research Report. 

Delaine Smith 


Operations Office Report 

24

Membership and 

Participating Sites 

During 2011, the ALLG welcomed 37 new 

members, including 14 haematologists 

and 2 radiation oncologists. 

Two of the new members 

were paediatric oncologists, 

reflecting the development 

of a partnership between 

adult and paediatric 

specialists in approaching 

the treatment needs of 

adolescents and young 

adults with haematological 

malignancy. The addition of 

8 haematology registrars 

as members augers well 

for the viability of the ALLG 

into the future. Reflecting 

the broad spectrum of 

professionals involved 

in the development 

of treatments and the 

management of patients 

with haematological cancer, 

8 scientists, 1 pharmacist 

and 1 behavioural scientist 

also became members. 

The ALLG membership 

remains steady with 324 

members. The table below 

details the number of 

members by location. 

new members 

2011 

37 

TOTAL members 

Location 

Members 

Australian Capital Territory (ACT) 7 

India 1 

New South Wales (NSW) 99 

New Zealand (NZ) 33 

Northern Territory (NT) 1 

Queensland (QLD) 37 

South Australia (SA) 32 

Tasmania (TAS) 10 

Victoria (VIC) 85 

Western Australia (WA) 19 

Total 324 

2011 

324 

25

Approved to participate in all ALLG trials 

Name Other current or recent names Code State Satellite of 

Australia 

Adelaide Cancer Centre Ashford Cancer Centre ACC SA 

Alfred Hospital ALF Vic 

Ararat East Grampians Health Service ARA Vic Ballarat 

Austin Hospital Austin Health AUS Vic 

Bacchus Marsh Hospital BAC Vic Ballarat 

Ballarat Oncology & Haematology Services Ballarat Base Hospital BAL Vic 

Bendigo Hospital BEN Vic 

Border Medical Oncology 

Albury Base Hospital (ALB), Murray Valley 

Private Hospital (MVP) (Ramsay Health), 

BMO NSW/ 

Vic 

Albury Wodonga Health 

Box Hill Hospital BXH Vic 

Cabrini Hospital CAB Vic 

Cairns Base Hospital CNS Qld 

Calvary Mater Newcastle Mater Misericordiae Hospital – Newcastle MMN NSW 

Canberra Hospital CAN ACT 

Coffs Harbour Hospital North Coast Cancer Institute – Coffs Harbour COF NSW 

Concord Hospital CON NSW 

Flinders Medical Centre FMC SA 

Frankston Hospital FRA Vic 

Fremantle Hospital FRE WA 

Geelong Hospital Barwon Health, Andrew Love Cancer Centre GEE Vic 

Gold Coast Hospital GCH Qld 

Gosford Hospital GOS NSW 

Greenslopes Private Hospital Gallipoli Research Centre RHG Qld 

Haematology Oncology Clinics of Australia Wesley Medical Centre, Mater private hospital, HOC Qld 

HOCA medical centre 

Launceston Hospital LAU Tas 

Lismore Base Hospital LIS NSW 

Liverpool Hospital LIV NSW 

Mater Adult Hospital Mater Misericordiae Hospital – Brisbane MAH Qld 

Monash Medical Centre MON Vic 

Nambour Hospital NAM Qld 

Nepean Hospital NEP NSW 

Northern Hospital Northern Health NOH Vic 

Peninsula Private Hospital Peninsula Oncology Centre, Frankston POC Vic 

Peter MacCallum Cancer Centre PMC Vic 

Port Macquarie Base Hospital North Coast Cancer Institute – Port Macquarie PMB NSW 

Prince of Wales POW NSW 

Princess Alexandra Hospital PAH Qld 

Princess Margaret Hospital for Children PMP WA 

Queen Elizabeth Hospital QEH SA 

Royal Adelaide Hospital IMVS ADE SA 

Royal Brisbane and Women’s Hospital Royal Brisbane Hospital RBH Qld 

Royal Children’s Hospital, Brisbane Queensland Children’s Cancer Centre CHB Qld 

Royal Children’s Hospital, Melbourne RCH Vic 

Royal Darwin Hospital RDH NT 

Membership and Participating Sites 

26

Approved to participate in all ALLG trials 

Name Other current or recent names Code State Satellite of 

Australia 

Royal Hobart Hospital HOB Tas 

Royal Melbourne Hospital RMH Vic 

Royal North Shore Hospital RNS NSW 

Royal Perth Hospital RPH WA 

Royal Prince Alfred Hospital RPA NSW 

Sir Charles Gairdner SCG WA 

St George Hospital STG NSW 

St Vincent’s Melbourne SVM Vic 

St Vincent’s and Mater Health Sydney St Vincent’s Sydney, Mater Sydney SVS NSW 

Tamworth Base Hospital TAM NSW 

Toowoomba Hospital TOO Qld 

Townsville Hospital TOW Qld 

Tweed Hospital TWE NSW 

Western Hospital WGH Vic 

Westmead Hospital WES NSW 

Wimmera Base Hospital WIM Vic Ballarat 

Wollongong Hospital WOL NSW 

Women’s and Children’s Hospital, Adelaide Children’s Youth and Women’s Health Service WCH SA 

Women’s and Children’s Health Network 

Wyong Hospital WYO NSW Gosford 

New Zealand 

Auckland Hospital AUC NZ 

Christchurch Hospital CHR NZ 

Dunedin Hospital DUN NZ 

Middlemore Hospital MID NZ 

North Shore Hospital NSH NZ 

Palmerston North PNH NZ 

Rotorua Hospital (NZ) ROH NZ Waikato 

Tauranga Hospital TAH NZ Waikato 

Waikato Hospital WAI NZ 

Wellington Hospital WEL NZ 

Restricted approval 

Name Other current or recent names Code State Approved for 

Australia 

Premion 

Premion – Tugun (John Flynn Private Hospital), PRT Qld NHL15 

Premion – Southport, Premion – Nambour 

(East Coast Cancer Centre) 

Griffith Base Hospital St Vincent’s Sydney GBH NSW One patient 

in apml4 

Canada 

Princess Margaret (Toronto) PMH NHLLOW5 

27

The National Leukaemia 

and Lymphoma Tissue Bank; 

a Joint Initiative of the ALLG and the Leukaemia Foundation 

The Tissue Bank was 

established to facilitate 


conducted in association 

with clinical trials and by 

independent researchers. 

Paula Marlton 

Tissue Bank Director 

Megan Ellis 

Tissue Bank Manager 

Background 

The Australasian Leukaemia 


(ALLG) National Tissue Bank 

housed at the Princess 

Alexandra Hospital (PAH) 

in Brisbane is a repository 

of high quality tissue 

samples collected from 

consenting patients with 

haematologic malignancies 

who are accrued to ALLG 

clinical trials and/or nontrial 

patients who are being 

treated in ALLG affiliated 

centres. 

An initiative of the ALLG 

in conjunction with the 

Leukaemia Foundation, 

the Tissue Bank was 

established by Associate 

Professor Paula Marlton and 

officially opened in October 

2002. It was initially run out 

of the molecular laboratory 

at PAH with a small seed 

grant from the Leukaemia 

Foundation. 

In 2006, laboratory and 

office space was provided 

by Pathology Queensland 

and an NHMRC enabling 

grant of $1.5m over 

5 years was awarded 

which facilitated adequate 

staffing and equipment for 

a fully functional facility. 

This funding along with 

increased support from 


through sponsors and other 

small grants has enabled 

the Tissue Bank to develop 

into a significant catalyst 

for translational research. 

The Tissue Bank was 

established to facilitate 


conducted in association 

with clinical trials AND by 

independent researchers. 

Consented patient’s 

samples are routinely 

collected and transported 

from 44 Australasian 

institutions to the Bank 

where they are processed, 

de-identified, stored 

and finally dispatched 

to research laboratories 

throughout Australia and 

overseas for approved 

projects. This has helped 

overcome one of the 

major rate limiting steps 

in translational research: 

access to adequate 

quantities of high quality 

clinically annotated 

tissue samples. 

Why the ALLG? 

• Largest network of 324 

haematologists from 

74 institutions actively 

involved in research 

in Australasia 

• Trial patients are 

uniformly treated 

according to strict 

protocols 

• Detailed clinical 

and outcomes data 

is collected on trial 

patients utilising 

well developed trials 

infrastructure 

• Diagnoses are 

rigorously established 

and confirmed 

Tissue Bank Report 

28

Benefits of the 

ALLG Tissue 

Bank 

Improved 

understanding of: 

• disease pathogenesis 

• biomarkers governing 

prognosis and response 

to treatment 

• potential therapeutic 

targets 

• diagnostic and 

monitoring tools 

Ultimately 

hastening clinically 

useful discoveries 

to improve therapy 

and patient 

outcomes 

Functions of the 

ALLG National 

Tissue Bank 

Trial patients 

• Co-ordination of trial 

patient samples for 

numerous multiinstitution 

national and 

international trials 

• Collection and high 

quality processing of 

samples of human 

tissue to meet intended 

analytic objectives 

(Trial Bank) 

• Provided Trial patients 

are also TB consented, 

any excess material 

not used for trial 

requirements can be 

made into samples 

for the Tissue Bank 

(thus making samples 

available for both the 

intended correlative 

studies and also 

available for approved 

future independent 

researchers). 

• Controlled and 

monitored storage of 

samples – 24 hrs a day, 

7 days a week 

• Dispatch of human 

tissue samples to 

approved researchers 

throughout Australasia 

and internationally using 

IATA guidelines and IATA 

trained staff 

• Specified laboratory trial 

analyses (translational 

research) 

Clinical trials per year 

Tissue Bank Facility services 

1 to Clinical Trials 

ALL5 

20 

15 

10 

5 

0 

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 

ALL6 

ALL7 

AMLM9 

AMLM10 

AMLM12 

AMLM13 

AMLM14 

(M16 in UK) 

AMLM15 

AMLM16 

HD3 

MDS3 

MDS4 

CML6 

CML8 

CML9 

CML10 

NHL21 

HD8 

NHL16 

NHl14 

NHl24 

NHL25 

CLL5 

CLL6 

CLL8 

CLL11 

MM13 

Gaudi 

GLP 

PARP 

PTLD1 

LBH/AZA 

APML4 

Rhumab 

ATAHC 

Dose Dense 

ABVD 

LY03 

LY05 

CLL2 

NHL11 

The facility has had 

involvement in 40 

clinical trials over time – 

involvement has either 

been via processing 

and storage specifically 

for trial correlative 

studies or where excess 

samples from tissue 

bank consented trial 

patients have been able 

to be stored into the 

Tissue Bank. 

29

TISSUE BANK 

HOLDINGS 

2011 

49,969 

SAMPLES FROM 

1,975 PATIENTS 

48 

Australasian 

institutions 

contributed 

samples 

Non-trial patients 

• Collection of samples 

from generically 

consented patients for 

ethically approved future 

unspecified research 

• Diagnostic data 

collected 

• Clinical data retrieved 

in collaboration with 

contributing institutions 

• Reciprocal MOUs 

in place with two 

paediatric tissue banks 

to facilitate bilateral 

access to samples and 

services 

• Diagnostic and follow up 

samples captured (serial 

sample sets available 

to facilitate disease 

monitoring studies) 

• Strict sample 

classification according 

to WHO Tumours of 

Haematopoietic and 

Lymphoid Tissues 

(>100 subtypes) 

• ALLG Website provides 

detailed information 

about the TB holdings 

and guidance for 

participation and 

access to samples 

Total samples made 

over time 

• ‘Trial Bank’: 

For designated research 

laboratories for trial 

specified analysis 

• ‘Tissue Bank’: 

For approved research 

applicants requesting 

samples 

Tissue Bank 

holdings available 

for approved 

research projects 

• Full holdings are listed 

on the ALLG website 

• The Tissue Bank is made 

up of 49,969 samples 

from 1,975 patients. 

• This includes samples 

from 1402 non-trial 

patients and 573 trial 

patients. 

• A total of 48 Australasian 

institutions have 

contributed samples 

• Each non-trial patient 

has a confirmed 

haematological 

malignancy with their 

diagnostic BM samples 

showing disease 

involvement. 

• Serial sample sets 

during treatment are 

collected on each 

patient where possible 

• For further detail on 

specific holdings or for 

a more comprehensive 

breakdown of specimen/ 

sample types, all 

researchers are 

requested to contact the 

ALLG Tissue Bank directly. 


30

2 

Tissue Bank Sample Capture 

(Shown by Year 2000–2011) 

3 

TOTAL SAMPLES PROCESSED 

BY STAFF since 2000 

10 

12 

NUMBER OF SAMPLES (,000) 

8 

6 

4 

2 

NUMBER 

NUMBER 

OF 

OF 

SAMPLES 

SAMPLES 

(,000) 

(,000) 

10 

8 

6 

4 

2 

0 

00 01 02 03 04 05 06 07 08 09 10 11 

0 

00 01 02 03 04 05 06 07 08 09 10 11 

Total trial bank samples made Total tissue bank samples made 

Total sample Number Per Year 

4 

450 

400 

350 

300 

250 

200 

150 

100 

50 

0 

Tissue Bank Sample Numbers 

Allocated to Researchers per Year 

2006 2007 2008 2009 2010 2011 

TB028 

TB027 

TB026 

TB025 

TB024 

TB023 

TB022 

TB021 

TB019 

TB018 

TB017 

TB015 

TB014 

TB013 

TB012 

TB011 

TB010 

TB009 

TB008 

TB007 

TB006 

TB005 

TB004 

TB002 

TB001 

There have been 

13 publications and 

26 presentations 

arising from Tissue Bank 

supplied independent 

researchers. 

31

5 

Tissue Bank Sample 

processed and stored 

6 

AMLM13 TRIAL 

(PATIENT ACCRUAL SHOWN 

PER INSTITUTION) 

3000 

8 

NUMBER OF SAMPLES 

2500 

2000 

1500 

1000 

500 

NUMBER OF PATIENTS 

6 

4 

2 

0 

2003 2004 2005 2006 2007 2008 2009 2010 2011 

Trial samples already dispatched for Current trial bank holdings 

defined trial testing 

0 

ADE BXH CAN CON GOS MAT MMN NEP PAH PMC RMH SVH WES 

Number of pts with only follow-up 

samples available for testing 

Number of pts with Dx 

samples sent for testing 

MDS4 TRIAL 



7 8 

NHL21 TRIAL 



12 

14 

10 

12 


8 

6 

4 


10 

8 

6 

4 

2 

2 

0 0 

ALB 

ALC 

AUS 

CAB 

CMN 

COF 

CON 

FMC 

FRE 

GEE 

GOS 

HOB 

HOC 

MON 

NEP 

RAH 

RMH 

RNS 

STG 

STV 

SVH 

WES 

WGH 

AUS 

BOH 

CON 

MAT 

NEP 

PAH 

PMC 

POW 

QEH 

RAH 

RMH 

RNS 

SCG 

STG 

STV 

SVH 

WES 

Number of patients which have not 

consented to correlative 

Number of patients which have 

consented to correlative studies 

Insufficient trial samples 

for correlative studies 

Trial samples outstanding Trial samples captured 

Figures 6, 7 and 8 show examples 

of sample capture rates provided 

for ALLG clinical trials as at 

October 2011. 


32

Tissue Bank Sample 

utilisation – up to 

11th October 

The samples provided to 

independent researchers 

have been made from 594 

of the 1,975 patients that 

have consented to tissue 

banking and whom have 

multiple samples stored. 

This means that 30% of the 

Tissue Bank’s total patient 

population has now been 

accessed for independent 

research projects. However, 

by having multiple samples 

made for each patient 

collection, it means that 

multiple researchers can 

now have access to the 

same patient. 

Trial Bank – For 

designated research 

laboratories for trial 

specified analysis 

• 1,834 trial samples have 

been dispatched for 

defined trial testing 

• 10,807 trial samples 

are currently held 

in the trial bank 

• The facility is currently 

providing specific sample 

processing for 19 clinical 

trials, 7 of which are 

actively accruing. 

11 of these are ALLG 

clinical trials and 8 

are non ALLG trials. 

• Regular feedback is 

being provided by staff 

to PIs and BaCT trial 

managers on individual 

trial sample capture 

rates (insufficient, 

captured, outstanding) 

and to all members 

biannually. 

• Reminders given to sites 

– Data Managers are 

contacted where there 

are outstanding samples 

from registered patients 

who have consented 

to correlative studies. 

Conclusion 

We would like to 

acknowledge and thank all 

ALLG Tissue Bank donors, 

data managers, research 

nurses, haematologists, 

registrars and pathology 

staff from all contributing 

institutions for their 

continued support. We also 

thank Royal Melbourne 

and Mater Newcastle staff 

specifically, as they continue 

to support and provide 

processed samples for 

ALLG tissue bank holdings. 

The ALLG Tissue bank is 

supported by the Leukaemia 

Foundation and its sponsors 

including Australian Air 

Express, and the National 

Health and Medical 

Research Council. 

Paula Marlton 

Tissue Bank Director 

Megan Ellis 

Tissue Bank Manager 

TRIAL BANK samples 

2011 

10,807 

1,834 

samples 

dispatched 

for defined 

trial testing 

33

Safety and Data 

Monitoring Committee 

(SDMC) Report 

The ALLG SDMC is an advisory committee 

to the SAC, it operates independently and 

includes at least three external members. 

The SDMC reviews all 

new proposed protocols 

and amendments which 

must be approved prior to 

dissemination to the HRECs 

at sites. The committee 

also reviews regularly all 

currently accruing trials and 

closed trials with patients 

still on treatment. 

Responsibilities 

of the SDMC 

1. Reviewing all protocols 

proposed for ALLG 

participation, whether 

ALLG initiated or 

international. 

2. Reviewing all proposed 

amendments to 

protocols prior to HREC 

submission. 

3. Reviewing urgent alerts 

involving safety issues 

and notifications that a 

stopping rule has been 

reached, if that stopping 

rule involves a safety 

issue. 

4. Reviewing reports on 

accrual and safety, 

safety stopping rules, 

and interim toxicity 

data for trials. 

5. Reviewing reports on 

accrual and recruitment 

rates with specific 

attention to the likelihood 

of the study answering 

its proposed question. 

6. Assessing the impact of 

independent scientific 

investigations, especially 

other trials, on the trial 

being monitored and 

recommending changes 

based on those external 

results. 

7. Ratifying any decisions 

made by other trial 

management committees. 

Summary of 

decisions made 

throughout 2011 

New studies 

approved to be 

activated: 

ALL6, AMLM16, MM13, 

NHL_X08, SC03 

Trial amendments 

approved: 

ALL5, BM07, CLL6, AMLM15, 

HD8, NHL21, NHL24, NHL25 

Standards and 

guidelines 

With the advent of national 

and international regulatory 

compliance, it is critical that 

the decision making power 

invested in the ALLG’s 

SDMC are carried out with 

diligence. Some of the many 

standards and guidelines 

that are incorporated to the 

review process are: 

• (the) National Statement 

on Ethical Conduct in 

Human Research, 2007; 

• (the) Australian Code for 

the Responsible Conduct 

of Research, 2007; 

• Values and Ethics: 

Guidelines for Ethical 

Conduct in Aboriginal 

and Torres Strait 

Islander Health 

Research, 2003; 

• NHMRC Australian 

Health Ethics Committee 

Position Statement – 

Monitoring and reporting 

safety for clinical trials 

involving therapeutic 

products, 2009 (AHEC 

position statement); 

• The Australian Clinical 

Trials Handbook, 2006; 

• Note for Guidance on 

Good Clinical Practice 

(CPMP/ICH/135/95) 

– Annotated with TGA 

Comments, 2000 (GCP); 

• Access to unapproved 

therapeutic goods 

– clinical trials in 

Australia, 2004; 

• Therapeutic Goods Act, 

1989; and Therapeutic 

Goods Regulations, 

1990. 

The ALLG SDMC meets four 

times a year, at a minimum, 

to undertake review of the 

ALLG clinical trial portfolio 

i.e. new trial protocols, 

studies in progress, studies 

closed to accrual and 

publications arising from 

ALLG research. 

I would like to personally 

express thanks to those 

members of the SDMC that 

so willingly and graciously 

donate their time and effort 

to the tasks involved in 

clinical trial safety and data 

review. 

SDMC Report 

34

Membership 

during 2011 

was as follows: 

ALLG Members 

Prof Peter Browett (Chair) 

Professor of Pathology – 

Haematologist 

Department of Molecular 

Medicine and Pathology 

University of Auckland, 

New Zealand 

Dr Robin Filshie 

(Newly elected 

in October 2011) 

Consultant Haematologist 

St Vincent’s Hospital, 

Melbourne 

Prof Andrew Grigg 

Director of Clinical 

Haematology 

Austin Health - Austin 

Hospital, Melbourne 

Prof Ray Lowenthal 

(January – July 2011) 

Haematologist/Medical 

Oncologist 

Royal Hobart Hospital, 

Tasmania 

External Advisors 

A/Prof Chris Karapetis 

(Newly elected in July 2011) 

Senior Consultant Medical 

Oncologist 

Flinders Medical Centre, 

South Australia 

Dr Patrick Kelly 

Senior Lecturer 

in Biostatistics 

University of Sydney, Sydney 

A/Prof Martin Stockler 

(January – April 2011) 

Consultant Medical 

Oncologist 

Royal Prince Alfred Hospital, 

Sydney 

Mr John Stubbs 

Executive Officer 

Cancer Voices Australia, 

Sydney 

ALLG Scientific 

Advisory Committee 

(SAC) Liaison 


Senior Staff Specialist 

Princess Alexandra 

Hospital, Brisbane 

ALLG Operations 

Office 

Delaine Smith 

ALLG Chief Executive Officer 

Cristina Conesa-Anghel 

ALLG Protocol Development 

Coordinator 

Dilu Uduwela 

ALLG Administration 

& Events Officer 

BaCT 

Representative(s) 

Mr Alan Herschtal 

BSc, BE, DipAppSc 

Biostatistician 

Ms Gaelle Dutu 

MSc(Statistics) 

Biostatistician 

35

Marketing Committee 

Report 

John Mortimore 

Director, ALLG Board 

In order to progress some of the key objectives 

set out in the ALLG’s new Strategic Plan, 

formally adopted on 4 February 2011, it was 

clear that the Board needed a sub-committee 

to focus on marketing issues and, specifically, 

revenue-raising. 

As a starting-point, Delaine 

Smith & John Mortimore 

cooperated in publishing 

a discussion draft covering 

a broad range of commentary 

and ideas about possible 

strategies. This was then 

used as a basis for the 

establishment of the 

Marketing Committee 

and setting the agendas 

for its initial meetings. 

Our first meeting was 

on 20 May 2011, and we 

had the following participants: 

John Mortimore, 

ALLG Board Member 

Geraldine Gray, 

ALLG Board Member 

Anne Hodgson, 

ALLG Consumer 

Representative 

Sandra Slatter, 

ALLG Consumer 

Representative 

Delaine Smith, 

ALLG Chief Executive Officer 

Melissa Benedict, 

ALLG Quality Coordinator: 

Grants 

Dilu Uduwela, 

ALLG Administration 

& Events Officer 

John Mortimore chaired the 

meeting and we agreed 

on a programme of forward 

actions directed towards 

articulating and implementing 

definitive strategies. In 

particular, we agreed on 

establishing stronger lines 

of contact with apparently 

filial organisations such as 


and the Lymphoma Australia, 

and seeking some “pro bono” 

support on web-site 

development and review 

of the ALLG logo-style. 

Another six (6) Committee 

meetings followed 

through 2011 and we 

were able to welcome 

Tania Cavaiuolo, General 

Manager – Marketing & 

Communications, The 


and Sharon Millman, 

President, Lymphoma 

Australia as participating 

members of our group at 

the year’s final meeting 

on 7 December 2011. 

Tania and Sharon have 

both enjoyed considerable 

success in developing 

and implementing the 

marketing strategies of their 

respective organisations 

and we are hopeful they will 

be able to contribute useful 

guidance to the ALLG from 

their experience. 

The Marketing Committee 

has commissioned new 

designs of the ALLG logostyle 

provided “pro bono” 

from sources associated 

with Committee members 

– and its members are 

working on the text and 

layouts of final drafts of new 

brochures and leaflets to be 

used to better publicise the 

ALLG and its mission. With 

further external “pro bono” 

guidance, the Committee is 

also aiming to develop and 

Marketing Committee Report 

36

launch a new ALLG website 

by mid 2012; and we have 

been able to start an ALLG 

image library with the 

assistance of Dr Constantine 

Tam (SAC member), the 

staff at St Vincent’s Cancer 

Centre and Jemimah 

Gray (Photographer). 

The Committee has 

commissioned a focus 

on potential donor 

organisations and Melissa 

Benedict has developed 

a categorisation that 

shows different potential 

groupings and the status 

of applications that have 

been made to individual 

organisations by the ALLG. 

Together with the SAC we 

are trying to formulate 

a scheme for increased 

ALLG responsiveness to the 

media on public interest 

issues in our field; and we 

are also endeavouring to 

find ways to better support 

the CEO and the Board in 

the ALLG’s ongoing dialogue 

with Government at all levels. 

some specific applications 

can be prepared during 

this “holiday period” with 

the aim of proceeding with 

them early in this New Year. 

John Mortimore 

Director, ALLG Board 

2012 promises to be an 

exciting year for the launch 

of new initiatives that we 

are working on, and most 

exciting of all would be 

a “break-through” on 

Tissue Bank funding. 

The Marketing Committee 

acknowledges that the 

ALLG’s principal current 

challenge is the continued 

funding of the Tissue Bank. 

With the Board and ALLG 

members in general we are 

urgently considering what 

approaches can be made to 

corporations and individuals 

for financial support. The 

Committee expects that 

37

Education and Grants 

The ALLG is committed to ensuring 

the conduct of quality research through 

the provision of education and training 

to the membership. In 2011, the ALLG 

provided a number of training options. 

Education 

and Training 

The ALLG is committed 

to ensuring the conduct of 

quality research through the 

provision of education and 

training to the membership. 

In 2011, the ALLG provided 

a number of training options. 

Training in Good 

Clinical Practice 

(GCP) 

This year, several forms of 

GCP training were offered 

to the ALLG membership. 

Nine associate members 

attended a two-day training 

course hosted by Nucleus 

Network and affiliate 

organisations, Beltas and 

Clinical Network Services. 

This 2-day classroom-based 

course was particularly 

suited to individuals who 

are new to clinical trials 

research. Jacquie Ruhl 

from Royal Darwin Hospital 

attended the course and 

found it highly valuable. 

“As I have limited experience 

in this field, the GCP training 

has helped me to gain 

essential insight into how 

to manage trials within 

the GCP guidelines. As 

well as governing my 

everyday practice I will use 

the experience to further 

develop SOPs for the 

department and hopefully 

find a way to streamline 

HREC applications 

in the NT.” 

Seven ALLG Members 

attended Nucleus Network’s 

Good Clinical Practice for 

Physicians and Investigators 

course on the Wednesday 

of the May Scientific 

Meeting in Melbourne. 

The course is designed 

for investigators who 

have less than two year’s 

experience in conducting 

clinical trials or who require 

a comprehensive up-todate 

refresher course for 

local and international 

regulatory requirements. 

All participants found the 

course highly valuable, 

including Dr Danny Hsu 

from Royal Prince Alfred 

Hospital. Dr Hsu commented 

that this was a “fantastic 

course that managed to 

compress a significant 

amount of information into 

a one day program that was 

interesting and extremely 

educational. Many thanks!” 

The ALLG also offered 

ClinfoSource online GCP 

training to those members 

who were unable to travel 

to the classroom-based 

workshops or preferred 

to complete the training 

in their own time. Four 

Associate Members and 

two Members completed 

the online training in 2011 

and all attendees found 

the courses relevant and 

valuable for their positions. 

Haematology 

Education days 

In 2007, education in the 

biology and treatment 

of haematological 

malignancies was identified 

as a poorly met need of 

ALLG data managers/ 

research nurses. ALLG 

Haematology Education 

Days focus on different 

disease topics and these 

days continue to be highly 

regarded by Associate 

Members. 

In partnership with Roche, 

the ALLG hosted two 


Days in 2011 in conjunction 

with the Scientific Meetings. 

In May, Dr Andrew Wei 

facilitated an education 

day dedicated to Acute 

Myeloid Leukaemia (AML) 

and Myelodysplasia (MDS). 

The day featured superb 

presentations from Andrew 

himself as well as Drs David 

Westerman, Melita Kenealy, 

Andrew Gurguis and 

Tse-Chieh Teh. The Myeloma 


Day was held in Brisbane 

in November and was 

organised by Dr Tony Mills. 

Excellent presentations 

were provided by Drs Kirk 

Morris, Jason Butler, Tara 

Cochrane, Laurie Catley, 

Sally Mapp, Peter Mollee as 

well as Tony himself. The 

ALLG is grateful to Roche 

for once again supporting 

these days in 2011. 


38

Specialist Certificate 

in Clinical Research 

(Oncology) 

With the support of 

Merck, Sharp and Dohme 

Australia, the ALLG offered 

four scholarships to 

ALLG members to attend 

the Specialist Certificate 


(Oncology) course at the 

University of Melbourne. 

This intensive course aims 

to provide participants 

with an understanding of 

the breadth of research 

in oncology and career 

opportunities as well 

as ethical and legal 

considerations relevant 

to clinical oncology 

research. Students also 

gain an appreciation of 

how to develop research 

proposals/study protocols 

and skills in the critical 

appraisal of presentations 

and publications in oncology 

research. 

This year, Dr Amanda 

Johnston (Westmead 

Hospital), Dr Ashish Bajel 

(Royal Melbourne Hospital), 

Dr Ketan Bavishi (Cairns 

Base Hospital) and Chris 

Twyford (Canberra Hospital) 

received scholarships 

to attend the course. All 

four participants found the 

course highly relevant 

and recommended it to 

peers pursuing a career 

in clinical research. 

Dr Johnston commented: 

Participating in the course has provided 

inspiration as well as practical background 

knowledge and skills that will enhance 

my participation as an investigator in 

ALLG trials and hopefully, after further 

experience, enable me to be involved 

in trial development as well as training. 

Dr Amanda Johnston 

One of four to receive a scholarship to attend the Specialist Certificate 

in Clinical Research (Oncology) course. 

“Participating in the course 

has provided inspiration 

as well as practical 

background knowledge 

and skills that will enhance 

my participation as an 

investigator in ALLG 

trials and hopefully, 

after further experience, 

enable me to be involved 

in trial development as 

well as training. I would 

recommend the course 

to final year advanced 

trainees in Haematology 

and junior staff specialists 

with an interest in clinical 

research and specifically 

clinical trials. The amount 

of knowledge gained in 

such a short period of time 

is invaluable.” The ALLG is 

delighted that Merck, Sharp 

and Dohme Australia has 

committed to supporting 

this program again in 2012. 

GSK CLL course 

in Stockholm 

GSK Australia once again 

extended an invitation for 

an ALLG haematologist 

to attend an advanced 

training course in chronic 

lymphocytic leukaemia 

(CLL) in 2011. Dr 

Mohammad Ali Bazargan, 

from St. Vincent’s Hospital 

in Melbourne, attended 

the Evolving Therapies 

and Diagnostics in Chronic 

Lymphocytic Leukaemia 

course at the Cancer Center 

Karolinska (CCK), Stockholm 

in March. Hosted by 

Professor Anders Osterborg, 

the two day course featured 

presentations on the 

molecular biology and 

prognostic indicators of 

CLL as well as treatment 

of refractory CLL and 

evolving therapies in CLL 

and the role of allogeneic 

transplant. Dr Bazargan 

thoroughly enjoyed the 

course and found the course 

to be “well organised, 

highly informative and 

with excellent speakers. 

As a haematology fellow 

who is to embark on a 

bigger research role, the 

course provided me with 

more current information, 

opportunity for more 

collaborative research as 

well as more ideas about 

possible future research 

projects. The knowledge 

gained during the course 

further motivated me to 

establish new projects and 

possibly pave the way for 

new clinical trials under 

ALLG umbrella.” 

39

Concept 

development 

In October, the ALLG offered 

scholarships for Members 

to travel to and attend 

the Concept Development 

Workshop for Trials and 

Translational Research 

Studies at the NHMRC 

Clinical Trials Centre. Dr 

Dipti Talaulikar from the 

Canberra Hospital not 

only secured an ALLG 

scholarship, but also an 

Oncology Scholarship 

from the NHMRC Clinical 

Trials Centre. Dr Talaulikar 

found the course useful for 

developing her lymphoma 

trial concept. “The 1-day 

concept development 

course offered through 

the NHMRC CTC was 

geared towards turning 

participants’ pre-screened 

ideas into successful 

clinical trials by providing 

a framework for writing 

clinical trial outlines. Each 

participant brought an 

evolving trial concept to 

the workshop. The day was 

divided into informative 

presentations, time to work 

on our concepts and most 

useful of all, constructive 

feedback on each idea by 

presenters/participants.” 

Future training 

for the ALLG 

membership 

The ALLG aims to provide 

access to the most 

appropriate training for 

ALLG clinicians and data 

managers/research nurses. 

Feedback from our members’ 

survey suggested that, while 

the current ALLG training 

program is appropriate, its 

expansion would further 

hone the skills of the 

membership. With this in 

mind, the ALLG is looking 

forward to providing access 

to more specialised training 

options in 2012. 

Funding support 

Successful funding 

applications in 2011 

The ALLG worked diligently 

throughout 2011 to secure 

financial support for ALLG 

projects scheduled to 

commence in 2011 and 

2012. Unfortunately, of 

twelve grant applications 

submitted in 2011, only two 

received positive outcomes. 

The ALLG was successful 

in its application to Cancer 

Australia’s Support for 

Cancer Clinical Trials 

scheme for an 18 month 

extension of funding. The 

purpose of this scheme 

is to build the capacity of 

Multi-site Collaborative 

National Cancer Clinical 

Trials Groups to promote 

cancer clinical trial conduct 

in Australia. This successful 

outcome will allow the ALLG 

to continue to manage the 

business and administration 

of the group. 

Further to the committed 

funding support from the 

Youth Cancer Network, the 

ALL6 clinical trial received a 

welcome boost in 2011 with 

a successful application to 

the Barr Family Foundation. 

The objective of the Barr 

Family Foundation is 

to enhance the lives of 

physically, mentally or 

health disadvantaged 

children and young people 

living in Victoria and the 

grant will support trial 

coordination costs to enable 

Victorian adolescents to 

participate in the trial. This 

project will give new hope 

to adolescent and young 

adult sufferers of acute 

lymphocytic leukaemia 

(ALL) and may offer study 

participants access to a 

potentially more effective 

treatment than they would 

otherwise receive. 

Unfortunately, ALLG 

applications to Perpetual 

Trustees (Barwon Health), 

NHMRC (HD8 correlative 

studies), Priority-driven 

Collaborative Cancer 

Research Scheme (PdCCRS) 

(HD8 correlative studies), 

Leukemia and Lymphoma 

Society (MDS4 correlative 

studies), Ramaciotti 

Foundation (Tissue Bank), 

Victorian Cancer Agency 

(education and training), 


(MDS3 correlative studies), 

Brain Foundation (NHL24 

correlative studies), ANZ 

Trustees (cytogenetics 

database) and Cancer & 

Bowel Research Trust (SC03 

trial) were unsuccessful. 

Continued efforts to source 

funding for CT’s, membership 

and education support will 

be pursued in 2012. 

Dr Melissa Benedict 

ALLG Quality Coordinator 

Funding from 

Pharmaceutical 

Companies 

Supporting 

Education and 

Training 

• Roche Australia – ALLG/ 

Roche QA partnership 

– financial support for 

QA activities, specifically 

haematology education. 

• Merck Sharp & Dohme 

– financial support 

for attendance of the 

University of Melbourne 

Specialist Certificate 


(Oncology) course 

• GlaxoSmithKline – 

financial support for 

an ALLG member to 

attend the Advanced 

Training Course on CLL 

in Stockholm, 2011 


40

Recent ALLG Grants from Competitive Sources (Trial and Infrastructure) 

Funding Body 

Year 

Awarded 

Year 

Commenced Grant Title Trial Value Duration 

Barr Family Foundation 2011 2012 Improving the treatment of Victorian 

teenagers with acute lymphoblastic 

leukaemia (ALL) 

ALL6 $180,000 3 years 


of Australia 


of Australia 

2010 2011 AMLM16 A phase 2 randomized 

study investigating the FLT3 inhibitor 

Sorafenib in sequence after intensive 

chemotherapy for untreated adult AML. 

2010 2011 MM13 Phase III Randomised trial of 

Melphalan and Dexamethasone +/- 

Bortezomib in AL Amyloidosis 

Cancer Australia 2010 2010 Australasian Leukaemia and Lymphoma 

Group (ALLG) Support for Cancer Clinical 

Trials Program 

PdCCR Scheme 2009 2010 HD8 Randomised phase III trial to assess 

response adapted therapy using PET 

in newly diagnosed advanced Hodgkin 

lymphoma 

Victorian Cancer Agency 2009 2009 Capacity building for Australasian 

Leukaemia and Lymphoma Group - 

Regional Program 

Cancer Australia 2007 2008 Support for Cancer Clinical Trials 

Program 

COSA 2007 2007 NHMRC EG awarded to COSA 

($1,840,000) for protocol development, 

data collection activities of the 

Cooperative Trial Groups 

NHMRC EG Round 3 

389202 Marlton 

NHMRC EG Round 2 

337911 Seymour 


of Australia 

2006 2006 Australasian Leukaemia Lymphoma 

Group (ALLG) National Leukaemia and 

Lymphoma Tissue Bank (NLLTB) 

2005 2005 Infrastructure support for the 

Australasian Leukaemia and Lymphoma 

Group (ALLG) Trial Centre 

2004 2004 ALLG Trial Centre funding for AMLM13 

trial and laboratory research 

AMLM16 $599,500 3 years 

MM13 $100,500 1 year 

– $1,501,697 3 years 

HD8 $340,000 3 years 

– $149,195 1 year 

– $1,141,248.90 2.5 years 

– $18,000 5 years 

– $1,500,000 5 years 

– $790,000 5 years 

AMLM13 $360,000 6 years 

41

Trial Centre Reports 

The ALLG has a number of trials coordinated 

from Centre for Biostatistics and Clinical Trials 

(BaCT) at Peter MacCallum Cancer Centre, 

the Royal Adelaide Hospital/SA Pathology 

in South Australia and from the Haematology 

Early Phase Clinical Research Unit (HepCRU) 

at Alfred Hospital in Victoria. Progress reports 

from the leaders of these units follow: 

Centre for 

Biostatistics and 

Clinical Trials 

(BaCT) 

BaCT continues to make 

a key contribution to 

achieving the ALLG 

objectives with respect to 

design, conduct, site staff 

education and publication 

of results. We are achieving 

this through providing 

statistical advice and 

collaborating with the ALLG 

clinicians on study set-up 

(including database and 

CRF design), site initiation, 

central trial coordination, 

data management, safety 

reporting and analysis of 

final results. 

During 2011, we worked 

with the ALLG on more 

than 40 projects, including 

15 actively recruiting 

trials of which four ALLG 

investigator lead studies 

(ALL7, AMLM15, CLL5 and 

MDS4 studies) were open 

in 2011. 

It has been a successful 

year with respect to 

progressing a number 

of logistically complex 

international studies. 

Lavanya Gupta has been 

key to ensuring activation 

of most sites for both HD08 

and NHL24 studies. Lavanya 

worked closely with HD08 PI, 

Judith Trotman, to accelerate 

HD08 recruitment to achieve 

new and reduced timeframes 

for this study. 

Significant effort was 

devoted by Gaelle Dutu, 

Gemma Tait, Caroline 

Sardjono and Juliana 

DiIulio towards progressing 

development and set up 

of new acute leukaemia/ 

myelodysplasia studies 

with a particular focus on 

AMLM15 and AMLM16. 

BaCT Trial Managers and 

Statisticians collaborated 

with the investigators 

to prepare data for 

abstracts, manuscripts 

and presentations for 

over 10 projects. Special 

mention is due to Juliana 

DiIulio and Jenny Beresford 

(APML4), Linda Cowan, 

Ditas Sioco, Robert Hannah 

and Emma Link (MDS3), 

Michael Kornhauser and 

Alan Herschtal (CML9) for 

their outstanding effort in 

preparing APML4, MDS3 

and CML9 data for analysis. 

We are continuing to 

improve and refine our 

methods and processes. 

BaCT has successfully 

implemented web-based 

registration and e-CRF 

systems as well as a 

streamlined electronic 

process for SAE review. 

BaCT statisticians now have 

capability in the area of 

adaptive Bayesian designs, 

which will be of particular 

interest to investigators 

working with early 

phase trials. 

Dina Neiger 

Director 

Centre for Biostatistics 

and Clinical Trials 

Peter MacCallum Cancer 

Centre 

Trial Centre Reports 

42

Royal Adelaide 

Hospital/SA 

Pathology 

The Royal Adelaide Hospital 

(RAH)/SA Pathology has 

undertaken the role of 

Trial Coordinating Centre 

for the ALLG’s CML10 

RESIST study. A first for 

the ALLG, this registry 

study data set will become 

the backbone of CML 

research, enabling improved 

concept development of 

future projects. The RAH 

has the role of creating 

the database, designing 

CRFs, receiving, entering 

and cleaning the data, 

and maintenance of site 

communication. 

The Molecular Pathology 

Lab at SA Pathology 

continues to offer highly 

sensitive mutation 

screening for patients 

enrolled on the CML10 

RESIST study. Recently, 

this screening has also 

been shown to identify 

a subgroup of patients who 

should receive a specific 

Tyrosine Kinase Inhibitor 

(TKI) as second line therapy. 

There appears to be great 

value in these types of 

collaborations, and the unit 

looks forward to further 

research collaborations in 

the context of managing 

ALLG trials. 

Bronwen Ortlepp 

Trial Centre Coordinator 

Royal Adelaide Hospital 

Haematology 

Early Phase 

Clinical Research 

Unit (HepCRU) 

The Haematology Early 

Phase Clinical Research 

Unit (HepCRU) based 

at the Alfred hospital 

specialises in early phase 

and investigator initiated 

trials with an emphasis on 

multiple myeloma and acute 

leukaemia, and includes 

3 Research Fellows and 

13 EFT of nurses, data 

managers, coordinators 

and scientists. This 

expertise and infrastructure 

enables the development 

and implementation of 

multicentre trials with 

a range of correlative 

laboratory studies. Within 

this context has been the 

establishment of myeloma 

MRD assays including 

flow cytometry and ASO- 

PCR that are currently 

incorporated into local and 

commercially sponsored 

trials, and will be utilised 

in ALLG sponsored clinical 

trials due to open in 2012. 

The HepCRU has 

successfully undertaken the 

local coordination centre for 

the international multiple 

myeloma trial MM11 and 

looks forward to adopting 

the trial coordination role 

for future ALLG myeloma 

and leukaemia trials. 

Nola Kennedy 

Manager, 

Clinical Research Unit 

Malignant Haematology & 

Stem Cell Transplantation 

Service 

Alfred Hospital 

The ALLG is grateful 

to the staff of the 

above trials centres 

for their diligent trial 

coordination of ALLG 

clinical trials and 

research projects. 

43

Collaborations 

The ALLG would like to extend a special thanks 

to all collaborators. 

Leukaemia 

Foundation 

The Leukaemia Foundation 

is the major Australian 

not for profit organisation 

dedicated to the care and 

cure of patients and families 

living with leukaemia, 

lymphoma, myeloma and 

related blood disorders. 

A partnership between the 

ALLG and the Leukaemia 

Foundation was formalised 

in January 2002 through 

the establishment of the 

National Leukaemia and 

Lymphoma Tissue Bank. 

The Foundation facilitated 

corporate sponsorship for 

this project and continues 

to support its operation 

today. The partnership also 

aims to promote patient 

involvement in clinical 

trials and clinical research 

in Australia and the 

Leukaemia Foundation has 

funded the ALLG AMLM13 

clinical trial since 2005. 

Lymphoma 

Australia 

Over the last year 

Lymphoma Australia has 

collaborated with the ALLG 

to ensure that information 

in relation to Lymphoma 

clinical trials and patient 

support materials are 

accurate and appropriate 

for the patient community. 

This information is currently 

available on the Lymphoma 

Australia website 

www.lymphoma.org.au in 

word format and as a DVD 

chapter and in our book 

“Living with Lymphoma”. 

In addition to this members 

of the ALLG have assisted 

Lymphoma Australia with 

education days for patients 

and their carers. A key 

focus for the Lymphoma 

education days has been 

the importance of clinical 

trials and how to access and 

understand this process. The 

knowledge and expertise 

of the ALLG clinicians has 

ensured both organisations 

were delivering similar 

messages about trials to this 

group of patients. 

Lymphoma Australia has 

also supported the ALLG, 

with letters of support to 

assist with the acquisition 

of research funds for 

Lymphoma research 

projects. 

This infrastructure funding is critical 

to the operational and business 

services of the ALLG, and our support 

from national and international 

organisations is highly valued. 

Collaborations 

44

Australian/New Zealand Collaborations 

Name 

Clinical Oncological Society of Australia 

Australasian Sarcoma Study Group 

Australasian Gastro Intestinal Trials Group 

Australasian Lung Trials Group 

Australian New Zealand Breast Trials Group 

Australia and New Zealand Children’s Haematology and Oncology Group 

Australia and New Zealand Germ Cell Trials Group 

Australia and New Zealand Gynaecology Oncology Group 

Australia and New Zealand Melanoma Trials Group 

Australian Prostate and Urogenital Trials Group 

Cooperative Trial Group for Neuro-Oncology 

Psycho-Oncology Cooperative Research Group 

Trans-Tasman Radiation Oncology Group 

Australasian Bone Marrow Transplant Recipient Registry 

Australian & New Zealand Mycoses Interest Group 

Chronic Lymphocytic Leukaemia Australian Research Consortium 

Haematology Society of Australia & New Zealand 

Code 

COSA 

ASSG 

AGITG 

ALTG 

ANZBTG 

ANZCHOG 

ANZGCTG 

ANZGOG 

ANZMTG 

APUG 

COGNO 

PoCoG 

TROG 

ABMTR 

ANZMIG 

CLLARC 

HSANZ 

Myeloma Foundation of Australia Inc 

International Collaborations 

Name 

Austrian Study Group AGMT (Arbeitsgemeinschaft Medikamentoese Tumortherapie) 

Central and Southern Lymphoma Group 

CLL Global Research Foundation 

European Organisation for Research and Treatment of Cancer – EORTC 

German High Grade NHL Study Group 

German Low Grade Lymphoma Study Group 

Groupe d’Etude des Lymphomes de l’Adulte – GELA 

Hemato-Oncologie voor Volwassenen Nederland – HOVON 

International Extranodal Study Group 

MD Anderson Hospital 

Medical Research Council – MRC 

National Cancer Institute of Canada 

National Cancer Research Institute – NCRI 

Country 

Austria 

UK 

USA 

Belgium 

Germany 

Germany 

France 

Netherlands 

Switzerland 

USA 

UK 

Canada 

UK 

In particular, the ALLG would like to extend a special thanks to all of the collaborators that provided letters of support for 

our application to Cancer Australia for ongoing infrastructure support. 

45

Allg Scientific Meeting 

2011 Sponsors 

Diamond 

Gold 

November 2011 

Silver 

May 2011 

May 2011 

November 2011 

Thank you for your contribution. 

We gratefully acknowledge your sponsorship. 

2011 Meeting Sponsors 

46

TRIALS IN PROGRESS



Page 

Disease Group Report 50 

ALL5 52 

ALL6 53 

ALL7 54 

AMLM14 55 

AMLM15 56 

MDS4 57 



BM07 59 




CML8 62 

CML9 63 

CML10 64 

PT1 65 



Page 


HD8 68 

NHL21 69 

NHL24 70 

NHL25 71 




CLL5 74 

CLL6 75 

NHL15 76 

NHLLOW5 77 

Myeloma 


MM11 80 

MM13 81 

Supportive care 




LS09 86 

LS12 87 

LS13 88 

LS14 89 

LS15 90 

49


Chairs 

Andrew Wei 

John Seymour 

Committee 

Ken Bradstock 

Luciano Dalla-Pozza 


James Gray 

Andrew Grigg 

Uwe Hahn 


Harry Iland 

Andrew Lim 

Paula Marlton 

Andrew Wei 

Chair 

The ALLG has so far conducted 4 randomised 

clinical trials in acute myeloid leukaemia 

(AML M2, M4, M7 and M12), which collectively 

involved almost 1,200 patients. 

The AMLM7 study (PI: Ken Bradstock) 

showed that post-remission 

intensification of cytarabine did not 

improve survival outcome and the 

NHMRC funded AMLM12 study (PI: 

Ken Bradstock), which completed 

accrual of 425 patients in May 2010, 

interrogated the role of further 

anthracycline intensification during the 

consolidation phase. Through these 

studies, the limits of chemotherapy 

intensity and efficacy will have 

almost been reached. The strategic 

future of AML investigation within 

the ALLG must therefore look toward 

incorporation of novel therapies 

either during the chemotherapy 

or post-remission phase. 

Partitioning and individualisation 

of therapy in AML via cytogenetic 

stratification has already occurred for 

core-binding factor (AMLM13; PI: Paula 

Marlton) and acute promyelocytic 

leukaemia (APML3 and APML4; 

PI: Harry Iland). The recognition of 

poor outcomes for FLT3-ITD AML 

has encouraged development of 

a randomised trial to investigate 

addition of the FLT3 inhibitor Sorafenib 

to standard chemotherapy and 

during maintenance (AMLM16; PI: 

Andrew Wei). This study will require 

engagement and collaboration 

between molecular centres in 

Australia to enable rapid and accurate 

identification of FLT3-ITD prior to 

randomisation between investigational 

arms on day 3 of chemotherapy. Within 

CBF AML, mutated c-KIT also identifies 

an AML sub-group with a higher 

risk of relapse. The role of targeting 

c-KIT using another small molecule 

inhibitor (PKC412 or Midostaurin) 

in combination with chemotherapy 

is currently under development (PI: 

Paula Marlton). In APML, the APML3 

trial results were successfully 

published in Haematologica in October 

2011 with Harry Iland as lead author. 

The highly successful APML4 followon 

study incorporating arsenic into 

APML induction and consolidation 

was presented at the Asian Oncology 

Summit in 2011. The failure-free 

survival with APML4 was 88%, 20% 

better than observed with APML3. 

These studies exemplify a growing 

trend that AML will be treated not as 

one, but rather as a growing number 

of distinct biological entities. With the 

complete genomic sequencing of the 

first AML genome in 2008, it appears 

likely that the vast majority of recurrent 

genetic abnormalities in AML will be 

fully defined within the next few years. 

This will continue to challenge our 

capacity to translate a growing list 

of molecular markers into the 

clinical setting. 

Although overall complete remission 

rates after intensive chemotherapy 

for newly diagnosed adult patients 

with AML is at least 80%, almost 50% 

are likely to relapse within the first 

1–2 years. This has sparked renewed 

interest in the role of maintenance 

therapies, such as lenalidomide 

(AMLM15; PI: Andrew Wei). AMLM15 

was activated in 2011 and will identify 

the maximum tolerated dose (MTD) 

of lenalidomide post-chemotherapy 

in patients not planned for allogeneic 

stem cell transplantation. A followon 

randomised study is planned to 

determine clinical efficacy once the 

MTD is defined. 


50


For elderly, unfit patients with AML, 

the ALLG completed a collaboration 

with the UK NCRI AML study group, led 

by Alan Burnett, in which Australian 

patients were randomised to receive 

either low-dose cytarabine or the 

novel nucleoside analogue clofarabine 

(AMLM14). For relapsed AML, a new 

study (AMLM17; PIs: Andrew Wei 

and Peter Tan) is being developed 

to investigate the role of high-dose 

lenalidomide alone, or in combination 

with epigenetic targeted therapies 

(either azacitidine or depsipeptide). 

This will be the first ALLG study 

to investigate salvage therapy 

options in AML. 

The likelihood that several AML 

studies are likely to run in parallel now 

and into the future has prompted a 

re-think on how to better coordinate 

the initial diagnostic assessment, 

genetic characterisation and induction 

chemotherapy treatment of patients 

with AML. An umbrella “AML Registry” 

that would serve as the initial “entrypoint” 

for all AML study patients is 

being developed to meet this need 

(AMLM18; PI: Andrew Wei). This is 

a formidable goal but one which 

has the potential to harmonise 

clinical studies in AML and provide a 

valuable repository of AML diagnostic, 

prognostic, treatment and outcome 

information that will increase in size 

and value with time. 

Genetic insights into the biology 

of MDS are also advancing at a 

remarkable pace and will no doubt 

influence how studies are designed 

for these conditions in the future. 

The establishment of azacitidine 

as standard-of-care for patients 

with high-risk MDS represents a 

paradigm shift in our approach to 

management of these patients. To 

further improve the positive outcomes 

with demethylating agents in MDS, 

a study combining azacitidine with 

the immunomodulatory agent 

thalidomide (MDS3; PIs: Melita 

Kenealy and John Seymour) was 

developed and completed in record 

time after meeting its accrual 

target of 80 patients. The follow-on 

MDS4 study (PIs: Melita Kenealy 

and John Seymour) is also accruing 

exceptionally well, and will determine 

using a randomised study design, if 

addition to the immunomodulatory 

drug lenalidomde to azacitidine has 

clinical potential in MDS. 

Continuing the theme of novel, 

targeted therapies in acute 

lymphoblastic leukaemia (ALL), 

the ALL5 study (PI: Andrew Grigg) 

is investigating the tolerability 

and clinical efficacy of dasatinib in 

combination with chemotherapy for 

patients with Philadelphia positive 

ALL. An important feature of this 

study will be the dynamic analysis 

of molecular response throughout 

treatment using highly sensitive 

molecular methods to monitor BCR- 

ABL levels. It is expected that the 

target accrual of 20 patients will be 

met in 2012. Two new ALL studies 

were opened in 2011, examining 

the role of mTOR inhibitors in 

combination with chemotherapy as 

salvage for relapsed B-ALL (ALL7; 

PI: Ken Bradstock) and paediatric 

approaches for adolescent young 

adult (AYA) patients with ALL (ALL6; 

PIs: Ken Bradstock and Luciano 

Dalla-Pozza). ALL6 will incorporate 

molecular monitoring of MRD to risk 

stratify patients with ALL together 

with informative clinical, genetic and 

molecular risk markers, enabling 

individualisation of therapy according 

to relapse risk. This study will 

determine if paediatric-style 

regimens are feasible in the adult 

setting with significant potential 

to alter clinical practice. 

To engage and adapt to the remarkable 

pace of discovery in acute leukaemia 

and MDS, our disease group faces 

several important challenges. How 

do we implement 

the technologies necessary to 

accurately define the increasing 

number of molecular lesions with 

prognostic and therapeutic relevance 

in these diseases? How do we 

continue to promote the feasibility 

of ALLG studies in a clinical trial 

environment with increasingly 

burdensome regulatory, governance 

and hospital resource pressures? 

How do we remain competitive in 

being able to conduct investigatorinitiated 

studies in Australia using 

novel agents targeted at increasingly 

smaller disease sub-groups? How 

can we maximise the value and 

academic impact of the clinical data 

and tumour samples we collect from 

patients now and into the future? To 

begin to meet these challenges, the 

Acute Leukaemia/MDS disease group 

must remain innovative and continue 

to develop high-quality research 

questions collaboratively to ensure 

that the studies we conduct are 

clinically meaningful and scientifically 

robust. Once again, we sincerely 

thank our ALLG colleagues for their 

outstanding support of trials within 

the Acute Leukaemia and MDS 

disease group. 

Dr Andrew Wei 

Chair 

51


ALL5 

A Phase II study of Dasatinib combined with induction chemotherapy 

in previously untreated de novo Philadelphia Chromosome-Positive Acute 

Lymphoblastic Leukaemia. 

Trial principal investigator 


Main trial objectives 

Investigation of the safety and tolerability of dasatinib in 

combination with induction chemotherapy for Ph+ ALL. 

PI Note: 

There has been steady accrual to this trial, as shown in the 

graph, with accrual target expected to be reached in 2012. 

The trial continuous to be safe and tolerable for all study 

participants, with a majority of who have not proceeded to 

an allograft. With short-medium term follow up, very low 

level residual bcr-abl positivity in the peripheral blood does 

not appear to predict for imminent relapse. Laboratory 

studies are underway which include reviews of dasatinib 

levels in blood and CSF. 

Website where trial registered: Australian New Zealand 

Clinical Trials Registry: ACTRN12607000609459 

Trial status: Open to accrual 

Date study opened: 14/10/2008 

Date 1st patient enrolled: 24/07/2009 

Accrual target (ALLG): 20 

Current total accrual (ALLG): 17 

Participating sites: 9 

Number of sites with patients entered: 6 

Expected final accrual date: October 2012 

Pharmaceutical company support: Bristol-Myers Squibb 

Comments: Current Protocol Version 6.0, 9 September 2011 

CML presenting as lymphoid blast crisis is now eligible. 

ALL5 Study Recruitment 

20 

15 

10 

5 

0 

2009 2010 2011 

Actual accrual 2 7 8 

Cumulative actual accrual 2 9 17 

x Cumulative expected accrual 2.5 7.5 12.5 


52


ALL6 

A Phase II trial of an intensive pediatric protocol incorporating post-induction 

stratification based on MRD levels for the treatment of adolescents aged 15 years 

and above, and young adults aged up to 40 years, with newly diagnosed 

Acute Lymphoblastic Leukaemia (ALL). 

Trial principal investigators 

A/Prof Ken Bradstock, Dr Luciano Dalla Pozza 


The Primary Objective is to determine whether a modified 

form of the BFM-2000 protocol can be administered to 

patients with newly diagnosed and untreated ALL aged 

between 15 and 40 years in a comparable timeframe to 

patients under 15 years of age to be measured by the 

proportion of patients starting Protocol M by day 94 after 

commencing therapy. 

PI Note: 

This project will be a national clinical trial to find a better 

way to treat adolescents 15 years and over, and adults 

up to 40 years, with a bone marrow cancer called acute 

lymphoblastic leukemia (ALL). This disease is the most 

common form of childhood cancer, but in over 80% of 

children can be cured with chemotherapy. Adults with 

ALL do much worse, and this trial will examine whether 

exactly the same treatment given to children can also 

be given to adults, and if so, are the results as good. 






Current total accrual (ALLG): n/a 

Expected final accrual date: 01/01/2017 

Support: The ALL6 study has received funding from 

collaborating partner organisations including Youth 

Cancer Network Vic/Tas, Youth Cancer Fund, Canteen 

and COSA. The study has received funding from the Barr 

Family Foundation. 

Comments: Current Protocol Version 1, 28 June 2011 

53


ALL7 

Phase 1 study of RAD001 (Everolimus) in combination with chemotherapy 

for treatment of relapsed adult Acute Lymphoblastic Leukemia (ALL). 


A/Prof Ken Bradstock 


To assess the safety of RAD001 given in combination with 

the Hyper CVAD regimen in patients with relapsed ALL. 

The primary measure of safety will be the duration of 

myelosuppression, as measured by time to recovery to grade 

2 neutropenia compared to historical data using the Hyper 

CVAD regimen alone on a similar group of patients. 

PI Note: 

This study will determine whether it is possible to safely 

give a new drug called RAD001, or everolimus, together 

with HyperCVAD. Recent research has shown that a crucial 

protein called mTOR inside ALL cells is responsible for 

keeping the leukemia cells alive and growing, and helps 

prevent them being killed by chemotherapy. One inhibitor 

of mTOR called RAD001 has been studied in the laboratory 

and shows activity against ALL. Based on this promising 

information, a clinical trial in people with relapsed ALL has 

been designed. 








Expected final accrual date: September 2012 

Pharmaceutical company support: Novartis 

Comments: Current Protocol Version 3, May 2010 

This trial opening in 2011, will commence accrual of patients in 2012. 


54


AMLM14 

A programme of development for older patients with Acute Myeloid Leukaemia 

and High Risk Myelodysplastic Syndrome [UK: NCR AML 16]. 


Dr Andrew Wei, Prof John Seymour 


Primary objective: 

To compare Low Dose Ara-C versus Low Dose Clofarabine. 

Secondary objectives: 

1. overall survival; 

2. complete remission (CR) achievement and reasons 

for failure (for induction questions); 

3. duration of remission, relapse rates and deaths 

in first CR; 

4. toxicity, both haematological and non haematological; 

5. supportive care requirements. 

[Adjusted for Aust & NZ] 

PI Note: 

On the 7th April 2011 correspondence from Professor Alan 

Burnett, the NCRI AML16 Principal Investigator that the 

Non-Intensive Clofarabine arm of the study had reached 

target accrual, thus closed to accrual. 

The ALLG opened the trial on the 5th May 2009, and 

recruited 18 of planned 80 to the Non-Intensive 

Clofarabine arm of the trial. 

Website where trial registered: ISRCTN 11036523 

Trial status: Closed to accrual 



Accrual target (international): Approx 2000. Nonintensive 

Arm: Approx 1250 | Intensive Arm: Approx 1250 

Accrual target (ALLG): Non-Intensive: 80 (Low dose 

Ara-C versus Low dose Clofarabine) 

Final accrual (international): 2,223 (1,417 intensive, 806 

non-intensive, 363 LDAC vs Clo) 

Final accrual (ALLG): 18 



Date study closed to accrual: 07/04/2011 

Reason for closure: Reached international accrual target 

Pharmaceutical company support: Hospira 

Comments: Current Protocol Version 6.1, November 2007 

With the completion of recruitment internationally, this trial closed to accrual 

in ANZ in 2011. 

55


AMLM15 

A pilot study exploring high-dose lenalidomide maintenance therapy in adult AML. 


Dr Andrew Wei 


Primary objectives: 

1. To assess safety and tolerability of lenalidomide 

maintenance in newly diagnosed AML patients; 

2. To determine the MTD of Lenalidomide during the first 

cycle of maintenance therapy. 


1. To provide preliminary data on cumulative incidence 

of relapse (CIR), cumulative incidence of death (CID), 

and overall survival (OS) at multiple timepoints during 

lenalidomide therapy; 

2. To provide preliminary data on the kinetics of minimal 

residual disease (by MRD flow cytometry and WT1 RT-PCR) 

during lenalidomide therapy; 

3. To assess quality of life during maintenance therapy 

(FACT-Leu questionnaire). 






Accrual target (ALLG): Approx 30–50 




Expected final accrual date: August 2012 

Pharmaceutical company support: Celgene 

Comments: Current Protocol Version 6, 20 June 2011 

The protocol has undergone two amendments to allow 

timely registration of patients and administrative 

clarifications. 

PI Note: 

The AML15 study will explore the role of escalating doses 

of lenalidomide in delaying disease relapse in adult patients 

with AML in first remission. 

The aim will be to find the maximum tolerated dose and 

then take forward into a larger randomised study. 

AMLM15 Study Recruitment 

15 

12 

9 

6 

3 

0 

2011 Q3 2011 Q4 

Actual accrual 3 6 

Cumulative actual accrual 3 9 

x Cumulative expected accrual 6.25 12.5 


56


MDS4 

A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus 

combination therapy with lenalidomide and 5azacitidine in patients with higher 

risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid 

leukaemia (AML). 


Dr Melita Kenealy 



To demonstrate improved efficacy with the combination of 

LEN and AZA compared to AZA alone in patients with MDS, 

nonproliferative CMML and low marrow blast count AML, 

with acceptable toxicity of the combination. 


1. To describe responses, duration of response and overall 

survival with AZA or LEN AZA in patients with MDS, 

nonproliferative CMML and low marrow blast count AML; 

2. To describe tolerability of the combination of LEN and 

AZA in patients with MDS, nonproliferative CMML and low 

marrow blast count AML; 

3. To explore biomarkers of response and mechanism 

of action of AZA and LEN in patients with MDS, 

nonproliferative CMML and low marrow blast count AML 

using a variety of correlative studies at baseline and on 

treatment correlated to individual clinical responses. 






Accrual target (ALLG): Approx 160 (80 eligible patients 

in each arm) 






Comments: Current Protocol Version 3, September 2010 

PI Note: 

It has been an active year for MDS4, a randomised study determining the clinical benefit of the addition of lenalidomide to 

azacitidine therapy in patients with higher risk myelodysplastic syndromes. Accrual has been steady after the first patient 

enrolled in early March 2011. With nearly 30 sites active and 70 patients registered by the end of the year accrual is well 

on target to reach the planned total 160 participants. There has been no unexpected toxicity of the combination 

to date. Tissue banking and correlative studies is a high priority with further funding secured for components of this work, 

and discussions around priorities and additional funding ongoing. 

MDS4 Study Recruitment 

100 

80 

60 

40 

20 

0 

2011 Q1 2011 Q2 2011 Q3 2011 Q4 

Actual accrual 5 11 32 22 

Cumulative actual accrual 5 16 48 70 

x Cumulative expected accrual 5 15 25 45 

57


Chairs 

David Ritchie 

Ian Lewis 

Committee 

Sharon Avery 

Ashish Bajel 


Ken Bradstock 

Julian Cooney 


Glen Kennedy 

John Moore 

Sushrut Patil 


Jeff Szer 


Agnes Yong 

David Ritchie 

Chair 

The BMT group has made significant progress 

in gathering together the lead BMT physicians 

across Australia and New Zealand. The 

motivation of the group is high as a result 

of the pursuit to determine the best clinical 

trial concept design to put into action 

at ALLG sites. 

The MAVRIC trial, “A randomized trial 

of Myelo-Ablative Versus Reduced 

Intensity Conditioning (MAVRIC) for 

AML”, underwent further development 

during 2011 after excellent input 

from the SDMC and BMT centre 

directors. The need for all BMT 

centres to support these initiatives 

was highlighted in these discussions. 

Encouraged and enlightened by the 

results German BMT study group of 

the first ever completed randomised 

study presented by Martin Bornhauser 

(ASH 2011; abstract 157), the rationale 

and feasibility of the MAVRIC study 

design was confirmed. The BMT group 

of the ALLG aims to further refine the 

study design early in 2012 and will 

invite participation by international 

centers. The central hypothesis, that 

a reduced intensity regimen will 

enhance tolerability and reduce the 

toxic effect of allogeneic transplant 

in AML remains an important question 

to answer. 

Two additional multicentre transplant 

proposals are being considered 

for participation through the ALLG. 

Both seek to answer the question 

whether reduced intensity allogeneic 

transplantation in patients with 

AML on CR1 who are older than 

50 can overcome the very poor 

outcomes associated chemotherapy 

consolidation in these older patients. 

Andrew Grigg continues to lead way in 

the realm of transplant induced Bone 

Mineral Density (BMD) research. The 

BM02 trial accrued 120 patients at 

5 sites between 1999 and 2002, and 

this randomised study demonstrated 

that a bisphosphonate markedly 

reduced post-allograft bone mineral 

density in the first 12 months, 

particularly in patients on high doses 

of immunosuppression. This study 

was a prelude to the current BM07 

study which looks at the effectiveness 

of pre-emptive use of a more powerful 

bisphosphonate, zoledronic acid, 

to prevent BMD loss in allograft 

recipients, with particular focus on 

those at high risk of BMD loss. BM07 

continues to recruit steadily and is 

expected to reach its target accrual 

of 120 patients in late 2012/early 

2013. Estimation of the mean 

percentage change in BMD at the 

femoral neck at day 100 will take 

place as soon as practicable after 

the last patient registered on the 

study completes the day 100 BMD 

assessment - this information will 

likely be presented at a conference 

of a professional society. All other 

statistical analyses and a final statistical 

report will be prepared when all 

patients have completed their 12 month 

BMD assessments, with a report 

available possibly as early as mid-2015. 

Discussions have been initiated with 

the Mayo clinic in Arizona regarding 

the participation of ALLG sites in a 

cross sectional analysis of late effects 

and quality of life following allogeneic 

transplantation. 


Chair 


58


BM07 

A treatment algorithm evaluating the effect of zoledronic acid on bone mineral 

density loss after allogeneic stem cell transplantation. 




To investigate the prophylactic use of zoledronic acid prior 

to allogeneic stem cell transplant (alloSCT) to alleviate the 

bone mineral density loss normally associated with BMT and 

subsequent steroid therapy as determined at day 100 and 

day 365 post transplant compared with baseline, where day 

0 is the day of transplant. 

PI Note: 

Accrual slower than anticipated but expected to be 

substantially improved with Westmead and Alfred coming 

on board as active participants. 

The study protocol has undergone a major amendment to 

allow pre-emptive Vitamin D supplementation which should 

overcome the ineligibility criteria of low Vitamin D levels 

when the first dose of zoemta is due. 











Pharmaceutical company support: Novartis 

Comments: Current Protocol Version 8.4, 26 October 2010 

Protocol amendment approved on 8 November 2010. 

BM07 Study Recruitment 

100 

80 

60 

40 

20 

0 

2008 2009 2010 2011 




59



Chairs 

Anthony Mills 

Timothy Hughes 

Committee 

Ashish Bajel 

Cecily Forsyth 

Andrew Grigg 

Simon He 


Steven Lane 

Anthony Mills 

David Ross 


Stephen Ting 

Anthony Mills 

Chair 

The myeloproliferative diseases subgroup 

had a very successful year in 2011, completing 

accrual of two trials in chronic myeloid 

leukaemia (CML8 and CML9) with initial 

presentation of the results of CML9 well 

received at the American Society of 

Haematology Annual Scientific Meeting. 

Accrual to CML10 is progressing 

rapidly and one trial in essential 

thrombocythaemia (PT1) remains 

open. Planning is well underway for 

subsequent trials in the MPN arena. 

CML6 continues in extended follow-up 

phase after publication in “Blood” in 

2008 and the large number of citations 

of this article to date is testament to 

the importance of this research. CML5 

was published in “Cancer” in 2007. The 

previous studies CML4 and 7 continue 

in evaluation or publishing phases. 

CML8 

Title: Trial of withdrawing imatinib 

in CML patients in stable molecular 

remission (TWISTER) 

The CML8 study is evaluating the 

controlled cessation of imatinib in 

CML patients who have achieved 

a sustained complete molecular 

response to treatment. Interim results 

support a similar French study and 

suggest that about 40% of patients in 

stable “complete molecular remission” 

remain in remission more than 2 

years post cessation. Both cohorts 

have now completed accrual, with 40 

patients recruited from eight sites. 

An interesting companion study is 

evaluating the role of patient specific 

DNA-PCR which is more sensitive 

than RT-RNA PCR and could provide 

greater predictive accuracy for long 

term remission. Initial results of this 

latter study have been published in 

Leukemia in 2010. PIs: Dr David Ross, 

Prof Timothy Hughes 

CML9 

Title: A Phase II study in adult 

patients with newly diagnosed 

chronic-phase chronic myeloid 

leukaemia of initial intensified 

imatinib therapy and sequential 

dose escalation followed by 

treatment with nilotinib in 

suboptimal responders to 

determine the rate and duration of 

major molecular response (TIDEL II) 

This is another large ALLG CML study 

that successfully completed accrual 

in May 2011. This is a phase II study in 

adults with newly diagnosed chronic 

phase CML, in two cohorts, with a 

total of 210 patients from 23 centres 

enrolled. After initial intensified, 

dose-adjusted imatinib, suboptimal 

responders in the first cohort had 

imatinib dose escalation followed by 

nilotinib for continued sub-optimal 

response. Cohort 2 also utilised initial 

intensified dose-adjusted imatinib 

followed by immediate nilotinib (rather 

than imatinib dose escalation) for suboptimal 

response. 

Early results show that rates 

of transformation, molecular 

response and overall survival are 

very favourable when compared 

to similar international studies. 

The trial has been of great interest 

to the international audience with 

presentation at the European 

Hematology Association and 

American Society of Hematology 

meetings in 2011. Publication 

of these results is expected soon. 

PI: Prof Timothy Hughes 


60



CML10 

Title: Response post Tyrosine 

Kinase Inhibitor: assessment of 

sensitivity and therapeutic response 

to next-line therapy in CML: 

The Australasian RESIST study 

This is a unique registry study to gain 

information on patients who cease 

or switch tyrosine kinase inhibitors 

(TKI), which began accrual during 

2010 and currently has 15 activated 

sites and 235 patients recruited. The 

aim is to enrol all patients with CML 

on TKI therapy. Scientific studies are 

included for those patients ceasing 

therapy or switching to an alternative 

therapy. The aim is to understand the 

indications for stopping therapy and 

patterns of TKI resistance and the 

outcome following changes in therapy. 

PI: Prof Timothy Hughes 

PT1 Study 

Title: A randomised trial to 

compare aspirin vs hydroxyurea/ 

aspirin in intermediate risk 

primary thrombocythaemia and 

aspirin only in low risk primary 

thrombocythaemia 

PT1 is the largest ever study 

involving patients with the essential 

thrombocythaemia. Over a thousand 

patients have been enrolled and the 

study is recruiting throughout the 

UK, Northern Ireland, Australia, New 

Zealand and France. The original 

protocol included high, intermediate 

and low risk arms. The high risk 

arm was a randomisation between 

hydroxyurea plus aspirin versus 

anagrelide plus aspirin. It closed in 

2004 and the results, demonstrating 

the superiority of hydroxyurea plus 

aspirin, were published. The remaining 

two arms: the intermediate risk 

randomising between hydroxyurea 

plus aspirin versus aspirin alone, and 

an observational study for low risk 

patients on aspirin alone, are open for 

recruitment. PI: Dr Cecily Forsyth 

Studies in planning 

A number of studies are in various 

stages of proposal and planning 

including: 

1. Nilotinib with pegylated interferon 

in de-novo chronic phase CML 

patients. 

2. A randomised study of imatinib 

versus dasatinib for patients who 

have not achieved CMR after at 

least 2 years of imatinib. 

3. A follow-on study for patients 

ceasing imatinib in “complete 

molecular remission”, utilising 

interferon +/- a vaccine to lessen 

the relapse rate. 

4. A trial of a novel JAK2 inhibitor for 

patients with myelofibrosis. 

Relevant Presentations 

Upfront Imatinib Therapy in CML 

Patients with Rapid Switching 

to Nilotinib for Failure to Achieve 

Molecular Targets or Intolerance 

Achieves High Overall Rates 

of Molecular Response and 

a Low Risk of Progression – 

An Update of the TIDEL-II 

Trial (ALLG CML9) 

David T. Yeung, Michael Osborn, 

Deborah L. White, Susan Branford, 

Michael Kornhauser, Cassandra Slader, 

Samar Issa, Devendra K Hiwase, Mark 

S. Hertzberg, Anthony P. Schwarer, 

Robin Filshie, Christopher K Arthur, 

Yiu Lam Kwan, Cecily J Forsyth, David 

Ross, Anthony K. Mills, Andrew Grigg, 

and Timothy P. Hughes. Blood (ASH 

Annual Meeting Abstracts), Nov 2011; 

118: 451. 

The Strategy of Early Nilotinib 

Switch Based on Failure to Achieve 

Optimal Molecular Targets 

on Imatinib May Not Overcome 

the Negative Impact of a Low 

OCT-1 Activity in De-Novo 

CP-CML Patients 

Deborah L. White, Verity A Saunders, 

Amity Frede, Kelvin GrootObbink, 

Cassandra Slader, David T. Yeung, 

Michael Osborn, Anthony K. Mills, 

Andrew Grigg, and Timothy P Hughes 

Blood (ASH Annual Meeting Abstracts), 

Nov 2011; 118: 1690. 

CML patients failing to achieve 

MMR by 12 months may benefit 

from dose escalation or switching 

to nilotinib: A 24 month update of 

results from the Tidel-II trial 

D Yeung, M Osborn, D White, S 

Branford, M Kornhauser, C Slader, D 

Hiwase, M Hertzberg, A Schwarer, M 

Filshie, C Arthur, L Kwan, C Forsyth, D 

Ross, A Mills, A Grigg, T Hughes 

Haematologica (EHA Annual Meeting 

Abstracts), Jun 2011; 96(s2): 55 

ALLG members are commended on 

their contributions that have enabled 

the above investigators to undertake 

and present scientific outcomes of 

such a high standard. 


Chair 

61



CML8 

Trial of withdrawing imatinib in CML patients in stable molecular remission. 


Prof Tim Hughes 


To assess what proportion of CML patients with stable 

complete molecular response (CMR) on imatinib for at least 

two years remain in complete molecular response (without 

recurrence of RQ-PCR-detectable BCR-ABL in blood) for two 

years after ceasing imatinib therapy. 

PI Note: 

The TWISTER study completed its accrual target of 40 

patients in 2011. Patients continue in active follow-up, 

with a number of patients still in the 2 year monitoring 

period, and most patients in the follow-up phase of the 

study. Patient-specific DNA PCR is being used to assess the 

level of residual disease in patients in complete molecular 

remission. The first publication of results from CML8 was in 

Leukemia at the end of 2010. The paper has been cited 15 

times, highlighting the level of interest in this ALLG study. 

Around 40% of patients who stopped imatinib remain in 

CMR. The remaining patients had molecular recurrence 

of CML detectable by RQ-PCR, and resumed imatinib 

treatment. Discussions are underway regarding 

a follow-on study. 











Reason for closure: Reached accrual target 

Pharmaceutical company support: Novartis Australia 

Comments: Current Protocol Version 2.1, 22 August 2008 

The analysis of the primary endpoint is expected to be performed in 2012/2013. 


62



CML9 

A Phase II study in adult patients with newly diagnosed chronic-phase chronic 

myeloid leukaemia of initial intensified imatinib therapy and sequential dose 

escalation followed by treatment with nilotinib in suboptimal responders 

to determine the rate and duration of major molecular response. 




To determine the rates of major molecular response (MMR), 

as determined by RQ-PCR and to estimate the duration 

of MMR. 

PI Note: 

Thanks to the 23 ALLG sites involved in the CML9 trial, 

recruitment was completed in the 2nd cohort in March 

2011, with 210 patients enrolled across cohorts 1 and 

2. Early results are encouraging from this trial using 

dose adjusted imatinib as frontline therapy, with nilotinib 

switching for patients failing early molecular targets. The 

rates of transformation, molecular response and overall 

survival are very favourable when compared to similar 

international studies, and had been of great interest 

to the international audience with presentation at the 

European Hematology Association and American Society 

of Hematology meetings in 2011. Publication these results 

are expected shortly. 






Accrual target (ALLG): 210 (Cohort 1 & 2) 

Final accrual (ALLG): Cohort 1: 105 | Cohort 2: 105 






Comments: ‘Cohort 1’ recruitment completed in 2009. 

Protocol amendment approved on 21st July 2010 

Current Protocol Version 4.0, 22 July 2010 

63



CML10 

Response post Tyrosine Kinase Inhibitor: assessment of sensitivity and therapeutic 

response to next-line therapy in CML: The Australasian RESIST study. 




To document the reasons and frequency of TKI cessation, 

the type of second line therapy selected and the outcome 

of second line therapy and to correlate the response 

of next-line therapy with laboratory assay results. 

PI Note: 

The CML10 (RESIST) trial is steadily gaining momentum. 

There are now 233 CML patients on the TKI registry and 

17 have entered the STOP registry. There are 15 sites 

with consent and 12 are accruing at the moment. At the 

November ALLG meeting it was clarified that patients 

already on other studies can be enrolled onto CML10. 

Centres enrolling to CML10 can access the newly 

developed massARRAY assay to look for low level 

mutations in their TKI-resistant patients as an aid 

to selecting next-line therapy. 






Accrual target (ALLG): TKI Registry: 1,000 | STOP 

Registry: 200 | Correlative Studies: 150 

Current total accrual (ALLG): TKI Registry: 233 | STOP 

Registry: 17 | Correlative Studies: 11 



Expected final accrual date: January 2014 

Pharmaceutical company support: Novartis, 

Bristol-Myers Squibb 

Comments: Current Protocol Version 1.0, 2 March 2010 

CML10 Study Recruitment 

500 

400 

300 

200 

100 

0 

2010 Q3 2010 Q4 2011 Q1 2011 Q2 2011 Q3 2011 Q4 

Actual accrual 63 20 10 21 72 47 

Cumulative actual accrual 63 83 93 114 186 233 

x Cumulative expected accrual 75 150 225 295 365 435 


64



PT1 

A randomised trial to compare aspirin vs hydroxyurea/aspirin in intermediate risk 

primary thrombocythaemia and aspirin only in low risk primary thrombocythaemia. 


Dr Cecily Forsyth 


Evaluate various therapies in Essential Thrombocythaemia. 

PI Note: 

Currently the trial is due to stop recruiting on 31st 

July 2012 (once the endpoint event analysis has been 

completed), but we are investigating keeping the low risk 

arm open for a further few years, as we have developed a 

great network of international MPN centres. It will be easier 

to manage the low risk arm as an observational study 

rather than a randomised clinical trial. 

Follow up data on all trial patients who are alive will 

be collected for a further 5 years. This will involve filling 

out a short CRF form once a year. 

Australia has contributed 46 pts to this study and 

recruitment continues at Gosford Hospital as the only 

actively recruiting ALLG site. 


Clinical Trials Registry 




Accrual target (international): Low Risk Arm: 250 

Intermediate Risk Arm: 560 

Accrual target (ALLG): n/a 

Current total accrual (international): 1,341 [Low Risk 

Arm: 241 / Intermediate Risk Arm: 351 / High Risk Arm: 

809 (Closed)] 





Pharmaceutical company support: Orphan 

Comments: Study unfunded for Australian New Zealand 

sites. Therefore, accrual limited at Gosford. 

High Risk Arm closed in 2003 after accruing 809 patients. 

Protocol amendment approved on 26th July 2010 

Current Protocol Version 1.1, 12 January 2006 

PT1 Study Recruitment 

50 

40 

30 

20 

10 

0 

1997–1999 2000–2002 2003–2005 2006–2008 2009–2011 

Actual accrual 12 20 2 10 2 

Cumulative actual accrual 12 32 34 44 46 

x Cumulative expected accrual 0 0 0 0 0 

65

High Grade Non-Hodgkin 

Lymphoma and Hodgkin Lymphoma 

Chair 


Committee 


Geoff Chong 


Uwe Hahn 

David Ma 


Dipti Talaulikar 


Andrew Wirth 

Max Wolf 


Chair 

The High Grade NHL and HL Disease Group 

has four clinical trials in ongoing active 

accrual. Three of these are randomised phase 

III studies being jointly undertaken with other 

co-operative trial groups in Europe and the UK. 

These include HD8 RATHL (UK Hodgkin 

Lymphoma Study Group) in Advanced 

Hodgkin Lymphoma, NHL24 (HOVON) 

in Primary CNS Lymphoma, and 

NHL25 (GELA) in Elderly DLBCL. 

The Disease Group Committee has 

expanded its membership and 

now has 10 clinician members. 

During 2011, we conducted two 

teleconferences in order to discuss 

and explore potential opportunities 

for new clinical trials in areas 

including Primary Mediastinal 

B-cell Lymphoma, Peripheral 

T-Cell Lymphoma, and “double-hit” 

B-cell Lymphomas. These carry the 

opportunity for additional trial activity 

in association with other co-operative 

trial groups in Europe in 2012. 

Studies in progress 

NHL21 

This trial evaluates the use of interim 

FDG-PET/CT scanning in DLBCL to 

identify poor early responders who 

are interim PET-positive after 4 cycles 

of R-CHOP14 and who will undergo 

treatment intensification using R-ICE 

(3 cycles) followed by Zevalin and 

BEAM chemotherapy and autologous 

stem cell transplantation. It includes 

real-time central PET review at 

Peter MacCallum. In collaboration 

with A/Prof Maher Gandhi, there are 

substantial correlative studies being 

undertaken that underpin some of 

the scientific questions being posed. 

The study is generously supported 

by Roche, Amgen, and Bayer in 

Australia. To date, 117 patients 

have been enrolled across 17 sites 

in a little over two years. A recent 

protocol amendment has allowed 

for the expansion to a total of 165 

patients with an expected number 

of approximately 33 PET positive 

patients. 

NHL24 

This is a phase III randomised study 

in Primary CNS Lymphoma being 

conducted in collaboration with the 

Dutch HOVON co-operative trial group 

and supported by Roche Australia. 

It involves randomisation of patients 

to either up-front Rituximab together 

with induction chemotherapy (using 

high dose methotrexate, Teniposide, 

BCNU, prednisone) versus induction 

chemotherapy alone. It incorporates 

collaborative laboratory studies as 

well as neuro-cognitive testing. Ten 

sites have recently been activated 

with accrual likely to accelerate 

during 2012. 

NHL25 (REMARC) 

This trial is being conducted in 

collaboration with the French GELA 

co-operative trial group and supported 

by Celgene Australia. It involves 

a double blind randomised phase 

III study of maintenance oral 

Lenalidomide versus placebo 

in elderly patients (60 to 80 yrs) 

who are in either complete or partial 

remission at the end of first-line 

R-CHOP-like chemotherapy. Fifteen 

sites have been or are currently being 

activated and accrual is encouraging. 


66



HD8 (RATHL) 

This trial is being conducted in 

collaboration with the UK Hodgkin 

Study Group and involves patients with 

advanced Hodgkin Lymphoma. It seeks 

to assess response-adapted therapy 

among those who are considered 

to have an adverse prognosis as 

identified by a positive interim PET 

scan following 2 cycles of induction 

ABVD chemotherapy. Those patients 

who are PET positive will receive 

intensified therapy with BEACOPP. 

Those who are PET negative are 

randomised to receive either ABVD 

or AVD (no Bleomycin) chemotherapy. 

The study involves a total of 15 sites 

most of whom have only recently been 

activated or are about to be activated. 

It includes extensive laboratory 

correlative studies being undertaken 

by A/Prof Maher Gandhi. There is also 

an economic evaluation component to 

the study. In ANZ the trial is supported 

by an NHMRC PdCCR scheme grant 

with funding partners Cancer Australia, 

the Leukaemia Foundation and 

Radiation Oncology. 

NHL_X08 

This Lymphoma Research proposal 

of inflammation and treatment 

tolerance is being conducted by 

Professor Stephen Clarke. It involves 

a retrospective evaluation of NHL07 

and NHL11 trials among aggressive 

NHL patients to explore the 

associations of the presence of 

B symptoms at baseline with the 

outcomes including toxicity, response 

rates, and survival. It is expected 

to be undertaken during 2012. 

Completed studies 

HD4 EORTC advanced 

Hodgkin Lymphoma study 

BEACOPP (4 cycles escalated + 4 

cycles baseline) versus ABVD (8 

cycles) in stage III & IV Hodgkin 

lymphoma. In the process of 

completion of data queries. 

HD9 Survivorship study 

Patterns of care study in HL survivors 

has been published and we are 

hopeful of further collaborations 

with the radiation oncologists. 

NHL07 CEOP vs SuperCEOP 

in DLBCL 

The final report is complete and is in 

the manuscript preparation stage. 

NHL11 HyperCVAD 

A phase II study of a modified 

Hyper-CVAD frontline therapy for 

patients with poor prognosis diffuse 

large B-cell and peripheral T-cell 

non-Hodgkin lymphoma. 

The trial data is now in the process 

of being finalised in preparation 

for analysis by the statistician 

in early 2012. 

NHL13 CORAL Study in 

relapsed/refractory DLBCL 

A number of publications and 

presentations have arisen from this 

study including recent updates in 2011 

at both ASCO and ICML, together with 

a manuscript in preparation currently. 

NHL18 Austrian DLBCL 

maintenance study 

A multicentre, randomized phase III 

study of rituximab as maintenance 

treatment versus observation alone 

in patients with aggressive 

B-cell lymphoma. 

NHL19 

(MInT follow-up) 

The MInT 6-yr follow-up data was 

presented at ICML, Lugano in 2011. 


Chair 

67



HD8 

A randomised Phase III trial to assess response adapted therapy using FDG-PET 

imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma. 


Dr Leanne Berkahn, Dr Judith Trotman 


To prospectively evaluate the role of PET-CT imaging after 

2 cycles of ABVD chemotherapy in the assessment of 

treatment response and management of patients receiving 

first line treatment for advanced Hodgkin Lymphoma. 

PI Note: 

The HD8/RATHL study is the first study to establish 

Australia and New Zealand haematologist and PET centre 

collaboration for standardised PET image acquisition 

and interpretation in a response adapted approach in 

Hodgkin Lymphoma. HD8 is now recruiting well with 35 

patients recruited at 10 active ALLG sites. The ALLG has 

developed a protocol amendment to enable additional 

health economic and Quality of Life evaluation. This value 

adding study will include cost effectiveness analysis of 

interim PET scanning in Hodgkin Lymphoma. An additional 

protocol amendment will enable the study of predictive and 

response biomarkers. 






Accrual target (international): 1200 


Current total accrual (international): 666 




Expected final accrual date: September 2014 

Comments: In ANZ the trial is supported by an NHMRC 

Priority Driven Cancer Collaborative Research Scheme 

grant, involving Cancer Australia, the Leukaemia Foundation 

and Radiation Oncology as funding partners. 

Current Protocol Version 4.0, 30 November 2009 

HD8 Study Recruitment 

40 

35 

30 

25 

20 

15 

10 

5 

0 

2010 Q3 2010 Q4 2011 Q1 2011 Q2 2011 Q3 2011 Q4 



x Cumulative expected accrual 3 8 14 21 29 37 


68



NHL21 

Early treatment intensification with R-ICE chemotherapy and autologous stem cell 

transplantation for patients with poor prognosis diffuse large B-Cell lymphoma 

as identified by interim PET/CT scan performed after four cycles of R-CHOP-14 

chemotherapy. 


Prof Mark Hertzberg, Prof Rodney Hicks 


The primary objective is to demonstrate an absolute 

improvement of 25% in two-year progression-free survival 

(PFS) from 40% to 65% in those patients with advanced 

DLBCL who have been identified with a positive interim PET/ 

CT scan and switched to early treatment intensification using 

R-ICE chemotherapy followed by HDCT/ASCT in comparison 

with historical controls. 

PI Note: 

NHL21 in DLBCL uses interim FDG-PET/CT scanning 

to identify poor early responders who are interim PETpositive 

after 4 cycles of R-CHOP14 and who will undergo 

treatment intensification using R-ICE (3 cycles) followed by 

Zevalin and BEAM chemotherapy and autologous stem cell 

transplantation. 

Given that the PET positive rate is 21%, ie, less than the 

originally anticipated 30%, the protocol has undergone 

an ammendment to increase the sample size. The timing 

of Pegfilgrastim administration with R-CHOP14 has been 

changed from day+2 to day+4 following a randomised study 

indicating superior survival and safety outcomes. 

A/Prof Maher Gandhi is undertaking correlative research 

studies in conjunction with the NHL21 trial. 










Expected final accrual date: February 2012 

Pharmaceutical company support: Bayer, Roche, Amgen 

Comments: Current Protocol Version 6, 2 September 2011 

NHL21 Study Recruitment 

120 

100 

80 

60 

40 

20 

0 

2009 2010 2011 



x Cumulative expected accrual 20 60 100 

69



NHL24 

Rituximab in Primary Central Nervous system Lymphoma (A randomized HOVON / 

ALLG intergroup study). 


Dr Samar Issa 



To assess the effect of the addition of rituximab in a standard 

chemotherapy regime on EFS in newly diagnosed PCNSL. 

Secondary objective: 

To evaluate the effect of the addition of rituximab to a 

standard chemotherapy regimen with respect to toxicity. 

PI Note: 

This is the first phase III international intergroup randomised 

trial in primary central nervous system lymphoma (PCNSL). 

The aim is to assess the effect of the addition of rituximab 

in a standard chemotherapy regimen on the EFS in newly 

diagnosed PCNSL. 

The study plans to enrol 200 patients over the period 

of 4 years. 

The first ALLG site was activated 24th November 2010, 

since then 6 more sites have been activated. The remaining 

6 sites are in the process of submitting to ethics or awaiting 

governance approval. 8 patients have been accrued so far 

from 3 sites. 19 patients are enrolled from the HOVON sites, 

this put the total number of patients enrolled into the study 

thus far to 27. 

This study also incorporates quality of life studies, detailed 

neuropsycological examination and biological studies that 

will help shed a light on this rare but highly aggressive 

subtype of NHL. 






Accrual target (international): 200 (100 per arm) 






Expected final accrual date: May 2014 

Pharmaceutical company support: Roche 

Comments: Current Protocol Version: 11 March 2011 


8 

7 

6 

5 

4 

3 

2 

1 

0 

2010 Q4 2011 Q1 2011 Q2 2011 Q3 2011 Q4 

Actual accrual 2 1 1 3 1 

Cumulative actual accrual 2 3 4 7 8 

x Cumulative expected accrual 1 2 4 6 8 


70



NHL25 

Double Blind Randomized Phase III study of lenalidomide (REVLIMID) maintenance 

versus placebo in responding elderly patients with DLBCL and treated with R-CHOP 

in first line. 


Dr Judith Trotman 



To determine the benefit estimated by the progressionfree 

survival associated with lenalidomide maintenance 

compared to placebo in responding patients treated in first 

line with R-CHOP for diffuse large B-cell lymphoma. 


To assess: 

1. percentage of patients who convert from PR to CR; 

2. efficacy according to the response to R-CHOP; 

3. overall survival in both groups of patients (with and 

without lenalidomide maintenance); 

4. safety of lenalidomide in maintenance. 






Accrual target (international): 621 (Randomized Patients) 

Accrual target (ALLG): 80–100 





Expected final accrual date: June 2013 


Comments: Current Protocol Version 4, June 2011 

PI Note: 

The NHL25 REMARC study recruitment is on target with 

14/80 ALLG patients recruited across 13 recently activated 

sites. Internationally the study recruitment is picking up 

well reaching more than one third of the target number 

of randomised patients. 


30 

25 

20 

15 

10 

5 

0 

2011 Q1 2011 Q2 2011 Q3 2011 Q4 




71



Chairs 

Stephen Mulligan 

Pauline Warburton 

Committee 

Duncan Carradice 

Bryone Kuss 

Kylie Mason 

John Seymour 



Stephen Mulligan 

Chair 

During 2011 the two CLL trials continued 

with steady recruitment, progressing 

toward milestones. 

CLL is the most common leukaemia 

in the western world and equates 

to 30% of all adult leukaemia. The 

standard treatment of fludarabine 

and cyclophosphamide +/- rituximab 

often results in residual disease after 

chemotherapy. 

CLL5 is a randomised study that 

explores the feasibility of treating 

previously untreated CLL patients aged 

65 years and older with a combination 

of different dosages of oral 

fludarabine, oral cyclophosphamide 

and iv rituximab. The second interim 

analysis of CLL5 showed that oral 

therapy appears generally safe and 

well tolerated in CLL patients aged ≥65 

years requiring first-line therapy. With 

stringent stopping criteria, about half 

the patients stop early due to toxicity, 

intercurrent illness, etc. Nevertheless 

response rates are high and accrual is 

good. Congratulations to PI: Stephen 

Mulligan on the presentation of the 

interim results; SP Mulligan, DS 

Gill, WEP Renwick, ML Sulda, OG 

Best, BJ Kuss, JF Seymour for the 

CLLARC and ALLG. The safety and 

tolerability of oral fludarabine, ±oral 

cyclophosphamide and iv rituximab 

therapy in previously untreated 

patients with Chronic Lymphocytic 

Leukaemia (CLL) aged ≥65 years – 

interim analysis from the Australasian 

Leukaemia and Lymphoma Group 

(ALLG) and CLL Australian Research 

Consortium (CLLARC) CLL5 Study. 

Blood 116(21), abst 699, 2010. There 

are 28 sites actively recruiting patients 

across Australasia, and with accrual 

at 109 of the target 120 it is expected 

that the trial will close in 2012. 

CLL6 is a phase II study for previously 

untreated patients aged less than 65 

years. All patients are treated with 

conventional dose fludarabine and 

cyclophosphamide with the option 

of adding rituximab to the regimen. 

Those with detectable disease 

after 4–6 cycles of treatment will 

be randomised to either no further 

treatment or to maintenance therapy 

with low dose oral lenalidomide for 

two years. The primary objective is 

to determine whether lenalidomide 

improves progression free 

survival. Lenalidomide, which is an 

immunomodulatory drug derived from 

thalidomide, is a highly active and 

well-tolerated agent. It appears to be 

capable of further improving response 

of patients with residual disease 

at the end of FC/FCR therapy. The 

aim of CLL6 is to give lenalidomide 

consolidation to achieve morphological 

Complete Remission (CR). The trial 

opened to accrual during 2011, with 

13 sites currently participating, 

9 patients registered and 1 patient 

randomised. The trial PI’s, David 

Gottlieb and Constantine Tam have 

incorporated leading correlative 

laboratory work to the trial looking 

at minimal residual disease, and 

immune reconstitution kinetics 

during lenalidomide consolidation. 

An important feature of this trial is the 

incorporation of Quality of Life (QOL) 

assessments for all patients and this 

will be analysed and reported on at the 

end of the trial period. 


72



The ALLG participated in the 

international study ‘A randomised trial 

of chlorambucil versus fludarabine 

as initial therapy of Waldenström’s 

macroglobulinaemia and splenic 

lymphoma with villous lymphocytes’. 

Led in Australia by PI: John Seymour 

the trial outcomes from LY03 were 

presented at American Society 

of Hematology in 2011. With a 

median follow-up of three years, the 

progression free survival time was 

significantly longer in the fludarabine 

arm, although OS was similar in 

both arms. Competitive risk analysis 

showed a significant difference in 

the cumulative incidence of second 

malignancies in the chlorambucil arm. 

The ALLG continues a strong 

partnership with the Trans-Tasman 

Radiation Oncology Group (TROG) via 

conduct of two recruiting trials TROG 

05.02/ALLG NHL15 and TROG 99.03/ 

ALLG NHLLOW5. 

NHL15 is a prospective single arm 

study of involved field radiotherapy 

alone for stage I or II low grade nongastric 

marginal zone lymphoma that 

continues to accrue slowly. 

NHLLOW5, is a randomised phase III 

trial of involved field radiotherapy with 

or without immunochemotherapy in 

stage I or II follicular lymphoma (FL) 

and is anticipated to close to accrual 

in 2012 since only an additional 

five patients are required for study 

completion. This unique study has 

been running for about 10 years and 

is the largest randomised trial ever 

conducted in early stage FL. If the trial 

is positive, it will profoundly influence 

management of stage I-II low grade 

follicular lymphoma world-wide. 

Since the closure of the PRIMA 

study a few years ago, the ALLG 

has been exploring a few options 

for participation in significant 

international trials in the field follicular 

lymphoma, and 2012 may well 

see adoption of at least one trial 

in this area. 


Chair 

73



CLL5 

An Australian, phase II multicentre, open-label, dose intensification study 

investigating poFCivR in previously untreated elderly (≥ 65) patients with CLL. 




To investigate the safety and tolerability of oral fludarabine 

plus i.v. rituximab (FR5), and oral fludarabine plus oral 

cyclophosphamide in varying dose intensity with i.v. 

rituximab (FCR3 and FCR5), in patients ≥ 65 years old 

with previously untreated CLL. 

PI Note: 

CLL5 is approaching completion of planned accrual with 

110 out of the target 120 patients randomised to date. 

Its importance in establishing the standard of care in 

chemotherapy for older patients with CLL was again 

highlighted by acceptance as an oral presentation at the 

International Workshop on CLL in Houston in October, 2011. 

An earlier update was accepted as an oral presentation at 

the American Society of Hematology in December 2010. 

Thus far, the overall patient cohort appears to tolerate the 

study therapies well and we look forward to reporting final 

results of this important study soon, particularly in view of 

the high level of international interest in this study. 











Pharmaceutical company support: Roche and Bayer 

Comments: Current Protocol Version 1, 11 January 2008 

CLL5 Study Recruitment 

120 

100 

80 

60 

40 

20 

0 

2008 2009 2010 2011 





74



CLL6 

An Australasian, Phase III, Multicentre, Randomised trial comparing lenalidomide 

consolidation vs no consolidation in patients with Chronic Lymphocytic Leukemia 

and residual disease following induction chemotherapy (RESIDUUM). 


A/Prof David Gottlieb, Dr Constantine Tam, 



The primary objective is to investigate if lenalidomide 

consolidation is capable of extending progression free 

survival (PFS) in previously untreated or minimally treated 

CLL patients with residual disease after chemotherapy. 

PI Note: 

This trial is open to patients over the age of 18 that meet 

eligibility criteria and who have not had previous treatment 

for CLL. Patients are randomised to either lenalidomide 

treatment or no lenalidomide treatment after having 

completed initial CLL treatment with standard chemotherapy 

FCR. Patients will undergo 3 treatment cycles of FCR and 

then undergo blood tests which determine if they can 

continue with further FCR chemotherapy. Further blood 

tests are collected prior to the patients commencing 

randomisation treatment. 






Accrual target (ALLG): Approx. 320 (Registered); 

192 (Randomised) 






Comments: Current Protocol Version 5.0, 

13 November 2010 

Protocol amendment approved on 19 November 2010 

CLL6 Study Recruitment 

60 

50 

40 

30 

20 

10 

0 

2011 Q2 2011 Q3 2011 Q4 




75



NHL15 

A prospective single arm trial of involved field radiotherapy alone for stage I-II 

low grade non-gastric marginal zone lymphoma. 


A/Prof Michael MacManus, Prof John Seymour, 

Dr Andrew Wirth 


In patients with stage I-II low grade marginal zone lymphoma, 

testing whether involved field radiotherapy will produce 

a complete response rate of >90%; radiotherapy will 

be associated with locoregional progression



NHLLOW5 

A randomised multicentre trial of involved field radiotherapy vs involved field 

radiotherapy plus chemotherapy in combination with Rituximab (Mabthera) for stage 

I-II low grade follicular lymphoma. 


Prof John Seymour, A/Prof Michael MacManus 


Primary endpoint is progression-free survival with 87% 

power to detect improvement in 5-year PFS from 60 to 75%. 

Also powered to detect OS benefit of 15% at 10 years. Central 

molecular monitoring and second malignancy data collected 

incorporated. 

PI Note: 

This trial, which is a landmark phase III study comparing 

involved field radiotherapy (IFRT) and IFRT plus systemic 

therapy in stage I-II follicular lymphoma, has recruited 

136 patients and is proceeding steadily. The systemic 

therapy component is R-CVP. 

Both arms have been well tolerated and radiotherapy 

quality control is excellent. Because the trial has accrued 

over a longer period than initially planned, it will be able 

to achieve its intended statistical power with a smaller 

than intended sample size. 

It remains the only trial ever to have addressed the role 

of systemic therapy in this setting with an adequate 

sample size. 











Pharmaceutical company support: Amgen Australia, 

Roche 

Comments: Protocol 15 December 1999, incorporating 

amendment 10 July 2006 

Amendment approved to add rituximab to chemotherapy 

regimen. 

In collaboration with Trans Tasman Radiation Oncology 

Group (TROG 99.03) 

NHLLOW5 Study Recruitment 

150 

120 

90 

60 

30 

0 

2000–2001 2002–2003 2004–2005 2006–2007 2008–2009 2010–2011 




77

Myeloma 

Chair 


Committee 


Laurie Catley 

James D’Rozario 

Anoop Enjeti 

Liam Fernyhough 

Simon Harrison 


Joy Ho 

Noemi Horvath 

Ian Kerridge 

Cindy Lee 


Miles Prince 

Ken Romeril 



Chair 

During 2011 there was only one active trial 

for the multiple myeloma and AL amyloidosis 

disease group. However there were three trials 

in development that should open to patient 

accrual in 2012 

Furthermore long-term follow-up 

of patients enrolled on the MM6 

trial for multiple myeloma was 

commenced and laboratory correlates 

associated with survival are also being 

investigated. Results of the MM8 trial 

in AL amyloidosis were presented at 

international meetings. 

Multiple Myeloma 

MM11, a collaborative study sponsored 

by GIMEMA (an Italian clinical trials 

group) opened in February 2010 

and closed in May 2011. This trial 

enrolled 380 patients, including 71 

from Australia. The aim of the study 

was to determine whether some of 

the newer drugs used in the treatment 

of multiple myeloma have sufficient 

activity that an autologous stem 

cell transplant no longer needs to 

be performed as an integral part of 

initial therapy. Patients aged 65 years 

or younger with newly diagnosed 

disease received four cycles of 

lenalidomide and dexamethasone, 

and were then randomised to a 

further six cycles of drug treatment 

with cyclophosphamide, lenalidomide 

and dexamethasone or the current 

standard therapy of autologous stem 

cell transplantation. Patients were also 

randomised to maintenance treatment 

with lenalidomide with or without 

prednisone. Final results of this trial 

are not expected for several years. 

MM6 was a trial that enrolled 224 

evaluable patients between February 

2002 and March 2005. The results of 

this trial showing improved survival 

in patients who received maintenance 

therapy with thalidomide in addition to 

prednisolone and zoledronic acid after 

autologous stem cell transplantation 

were published in 2009. Two followup 

studies were commenced in 2011. 

One study aims to examine long-term 

survival in trial participants and the 

other is a laboratory correlative study 

using banked tissue specimens. 

Two other trials are expected to open 

to accrual of patients in 2012. The 

first is a randomised phase II study of 

the use of pomalidomide in patients 

who have failed treatment with 

lenalidomide. Patients will receive 

induction treatment with four cycles 

of pomalidomide and dexamethasone. 

Responding and stable patients will 

then be randomised to maintenance 

treatment with pomalidomide 

alone or pomalidomide combined 

with dexamethasone. It is hoped 

to determine whether ongoing 

dexamethasone is necessary 

to maintain an ongoing response 

to pomalidomide. There will be 

associated laboratory studies to 

investigate whether the ongoing use 

of dexamethasone impacts negatively 

on the ability to mount an immune 

response against the myeloma. 

The second new trial is a collaboration 

with the European Myeloma Network. 

This is a phase III trial in patients 

aged less than 66 years that is 

designed to determine whether the 

combination of bortezomib, melphalan 

and prednisone is as effective as 

autologous stem cell transplantation 

in achieving prolonged response 

when administered as part of firstline 

therapy. The use of consolidation 

with bortezomib, lenalidomide and 

dexamethasone prior to maintenance 

lenalidomide will also be evaluated. 


78

Myeloma 

Systemic Light-Chain (AL) 

Amyloidosis 

Amyloidosis is a disorder caused 

by deposition of insoluble protein 

in various organs of the body. It can 

be caused by more than 25 known 

proteins. In AL amyloidosis it is caused 

by the deposition of immunoglobulin 

light chains (a fragment of antibody 

molecules). 

It was hoped that a trial in systemic 

AL amyloidosis being conducted 

in collaboration with the European 

myeloma Network would open to 

accrual during 2011. Due to logistical 

issues beyond the control of the ALLG 

this did not happen. These issues have 

now been resolved and the accrual 

of patients will commence in early 

2012. AL amyloidosis is a rare disease 

and international collaboration is 

essential to the development of better 

treatments. This phase III trial, to 

be known as MM13, will randomise 

patients with previously untreated 

AL amyloidosis who are ineligible for 

autologous peripheral blood stem 

cell transplantation to treatment with 

melphalan and dexamethasone with 

or without bortezomib. The patients 

will be stratified on the basis of the 

cardiac dysfunction, as the degree of 

cardiac impairment is known to be 

linked to survival. The plan is to recruit 

a total of 110 patients with Australia 

contributing 30 patients to the trial. 

In addition the ALLG will be collecting 

serum and tissue biopsy samples 

from patients for use in translational 

research designed to improve: 

1. the ability to accurately distinguish 

AL amyloidosis from other types of 

amyloidosis; 

2. the tests used for monitoring the 

patient’s response to therapy; 

3. the understanding of the reason 

some immunoglobulin light chains 

cause AL amyloidosis while others 

do not. 

A grant from the Leukaemia 

Foundation of Australia will fund both 

the conduct of the clinical trial and the 

translational laboratory studies. 

The results of a previous trial in AL 

amyloidosis (MM8) were presented 

at the 13th International Myeloma 

Workshop in April 2011 and the 

American Society of Hematology 

Annual Meeting in December 

2011. This was a phase II study to 

investigate whether intermediate dose 

intravenous melphalan might result in 

more rapid and better responses that 

historically seen with oral melphalan. 

Unfortunately this treatment proved to 

be too myelotoxic. 


Chair 

79

Myeloma 

MM11 

A Phase III, multicentre, randomized, controlled study to determine the efficacy 

and safety of cyclophosphamide, lenalidomide and dexamethasone (CRD) versus 

melphalan (200 mg/m2) followed by stem cell transplant in newly diagnosed 

Multiple Myeloma subjects. 


Prof Andrew Spencer 



To compare the efficacy of the combination of lenalidomide 

with low-dose alkylating agents versus high-dose 

melphalan in newly diagnosed, symptomatic MM patients. 


1. co assess the safety of lenalidomide with low-dose 

alkylating agents compared to high-dose melphalan in 

newly diagnosed, symptomatic MM patients; 

2. to assess the prognostic value of risk factor at diagnosis 

(Beta2-microglobulin, albumin, C-reactive protein, 

cytogenetics); 

3. to assess the efficacy and safety of lenalidomide as 

maintenance treatment after the consolidation phase; 

4. to assess prognostic significance of stringent remission 

evaluated by free light chain assay. 

PI Note: 

The MM11 trial successfully completed international 

accrual during 2011, with the ALLG contributing a total 

of 71 participants. 

Website where trial registered: European Registry: 

OSSC (Osservatorio Sperimentazioni Cliniche) | EudraCT 

Number: 2008-008599-15 




Accrual target (international): 380 (190 in arm A and 190 

in arm B ) 


Final accrual (international): 380 (190 in arm A and 190 

in arm B ) 







Comments: Current Protocol Version 1.0, September 2009 


80

Myeloma 

MM13 

A randomized open-label multicenter phase III trial of Melphalan and 

Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone 

(BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. 


Dr Peter Mollee 



To compare in patients treated with MDex or BMDex 

haematologic response after 3 cycles. 


To compare in patients treated with MDex or BMDex: 

1. complete haematologic response rate after 3 cycles and 

after completion of therapy; 

2. haematologic response rate at completion of therapy; 

3. organ response rates at 3, 6, 9 and 12 months; 

4. treatment-related mortality; 

5. toxicity; 

6. overall and progression-free survival; 

7. time to haematologic and organ response; 

8. quality of life. 




Date study opened: 






Pharmaceutical company support: Janssen Cilag 

Comments: Current Protocol Version 9.4 ANZ region 2 – 

December 10, 2010 

PI Note: 

The MM13 trial will open at 7 sites (PAH, Gosford, 

Westmead, Alfred, St Vincent’s Melbourne, Royal Adelaide, 

SCGH), with initiation expected to be complete in 2012. The 

trial is supported by the EMN and locally with a Leukaemia 

Foundation research grant. There are currently several 

international groups participating with accrual at 

8 patients internationally. 

81


Chair 


Committee 

Sharon Avery 

Peter Bardy 





Chair 

The Supportive Care Group has a broad 

agenda to ensure all trials have appropriate 

supportive care interventions and to also 

continue the implementation of stand-alone 

supportive care studies with members 

of the ALLG. 

During 2011, significant work was 

done to finalise a protocol assessing 

Chemotherapy Induced Nausea and 

Vomiting (CINV) in patients receiving 

R-CHOP chemotherapy for NHL. 

There is a lack of consensus on 

the use of prophylactic antiemetics 

for moderately emetogenic 

chemotherapy regimens such as 

R-CHOP. A contributing factor is 

that the incidence of nausea and 

vomiting in patients receiving these 

regimens is not clearly documented. 

In Australia, the anti-emetic Emend 

(aprepitant) is not funded for initial 

prophylaxis for R-CHOP regimens. 

However, it is approved for use in 

breast cancer patients receiving 

adjuvant chemotherapy with 

doxorubicin and cyclophosphamide, 

based on a randomised trial 

demonstrating benefit. A recent 

study demonstrated that aprepitant 

was superior in providing complete 

control (no vomiting and no use of 

rescue medication) in a variety of 

anthracycline/cyclophosphamide 

containing regimens. 

SC03 (PI: Andrew Grigg and CoPI: 

Christine Carrington) is a single arm 

study which proposes to evaluate the 

effectiveness of anti-emetic control 

using a standardised 5HT3 antagonistcontaining 

regimen (eg ondanestron) 

in a heterogeneous group of patients 

receiving R-CHOP chemotherapy for 

NHL for at least 3 cycles. Patients can 

be de newly diagnosed or relapsed, 

and both 14 day and 21 day cycles 

will be included. The study will also 

investigate the effectiveness of 

additional measures such as the use 

of aprepitant in subsequent cycles and 

major toxicities likely to be related to 

antiemetics. It is intended to conduct 

the study at 6-8 large hospitals in 

Australia, recruiting a total of 130 

patients. The analysis of these results 

will determine the incidence and 

severity of nausea in patients receiving 

R-CHOP and the effectiveness of 

antiemetic regimens. A potential 

randomized study evaluating the 

role of aprepitant could then be 

contemplated in high risk groups. 

The protocol received SDMC approval 

in October, and will be activated at 

sites in 2012. 


82


The ALLG’s land-mark trial SC01 

ASPID Study, assessing the clinical 

value of serological and molecular 

tests for diagnosing Invasive 

Aspergillosis in high-risk haematology 

patients, successfully completed 

accrual and follow-up of 240 patients 

in 2009. The primary endpoint is 

the proportion of patients treated 

with empiric antifungal therapy 

and analysis of the trial outcomes 

commenced in 2010. The study PIs 

Monica Slavin and Orla Morrissey 

anticipate publication of the study 

results in early 2012. 

The ALLG continues to support and 

encourage accrual to the Melbourne 

IVF study which is assessing ovarian 

function in patients at six months and 

three years after treatment for NHL. 

Half the women involved in the trial 

will receive 6 cycles of R-CHOP-14 

chemotherapy with a progesteroneonly 

oral contraceptive pill, and the 

other half will receive the same plus 

GnRH-a. The study PI Kate Stern, is 

conducting the study via Melbourne 

IVF, and aims to assess a range of 

health impacts, including pregnancy 

outcomes and Quality of Life (QOL). 

Franca Agresta is the central contact 

at MIVF [franca.agresta@mivf.com.au]. 

The ALLG remains strongly engaged 

with Professor Madeleine King and 

Rebecca Mercieca of the Quality of 

Life Office, Psycho-oncology Cooperative 

Research Group (PoCoG) 

in Sydney. The ALLG, with a long 

standing successful research history 

is a prime group to assess the use 

and outcomes of QOL assessment 

in clinical trials. Toward the end of 

2011 are large audit of the ALLG 

clinical trial program was undertaken, 

we expect from this to establish a 

comprehensive register to track and 

manage QOL in relation to trials. This 

will allow us to derive meaningful data 

on the evolution of QOL tools, the value 

of QOL in haematology and begin to 

set up a framework for ongoing QOL 

assessment in all ALLG trials. 


Chair 

83


Committee Report 

Chair 

Maher Gandhi 

Committee 

Peter Browett 

Lynda Campbell 

David Curtis 

Megan Ellis 

Anoop Enjeti 

Joy Ho 

Samar Issa 

Bryone Kuss 

David Ma 

Paula Marlton 

David Ritchie 

Andrew Roberts 


Annabel Tuckfield 

Andrew Wei 

David Westerman 

Deborah White 

Maher Gandhi 

Chair 

Recent developments in haematological 

malignancies have served to demonstrate 

the critical importance of strong translational 

science within trial consortiums. 

Within the Australasian arena, perhaps 

the best example is the pioneering 

work of the Adelaide group in the 

context of the ALLG CML studies, who 

have consistently shown the synergy 

that can be achieved when clinical 

trials are supplemented by state of 

the art biological assays answering 

relevant scientific questions. 

The aim of the Lab Sciences 

Committee (LSC) is for all clinical 

trials within the ALLG portfolio to be 

considered for translational correlative 

studies. In addition, a growing number 

of stand-alone laboratory studies 

are being accommodated. In both 

scenarios, scientists are increasingly 

recognising the unique position the 

ALLG has of coordinating retrieval of 

fully-annotated patient samples, taken 

in a uniform manner from multiple 

haematology units across Australia. 

As such, the LSC’s interests 

encompass most of the disease 

groups, with membership of the 

committee continuing to expand. 

Expertise within the group is broad, 

covering molecular, genetic and 

immunological aspects of a range 

of leukaemias, plasma cell dycsrasias 

and lymphomas, with strong 

representation from both scientists 

and clinicians from throughout 

Australia and New Zealand. Assembly 

of the LSC occurs at the ALLG biannual 

scientific meetings, at which new 

proposals and updates on ongoing 

studies are discussed. Teleconference 

facilities are available for those who 

are unable to attend in person. The 

LSC is always keen to recruit new 

members, to hear of new proposals, 

or to facilitate collaborations between 

scientists 

and clinicians. 

An important component of the LSC 

is to provide scientific oversight to new 

proposals by investigators wishing 

to utilise the Tissue Bank’s (ALLGTB) 

resources. Enquiries are made to 

the ALLGTB regarding availability of 

samples, and then a formal proposal 

with appropriate documentation 

(including evidence of ethics approval) 

made. This is then circulated to LSC 

members for comment. We generally 

provide a 2 week turnaround, but 

will sometimes need to seek further 

clarification of issues before a decision 

can be made. The aim is to ensure 

appropriate usage of ALLGTB tissues 

and prevent duplication of studies. 

In this regard, the peer review we 

provide is distinct from that of a grant 

awarding body. Our view is that the 

ALLGTB tissues are there to be 

utilised, and we strongly encourage 

applications to make use of the 

extensive range of tissues that have 

already been collected. 

2011 has seen considerable activity 

in correlative studies. In myeloma, 

following the success of T-cell studies 

in previous projects, Joy Ho and 

Andrew Spencer have completed their 

analysis of the MM6 trial, involving the 

impact of thalidomide on the subset of 

patients with dysregulated expression 

of the fibroblast growth factor 

receptor-3 (FGFR3) on progression 

free survival (PFS). They find that 

although consolidation thalidomide 

may mitigate the poor prognostic 

effect of t(4;14), it improves PFS in 

those with normal but not upregulated 

FGFR3 expression. Thus the level of 

FGFR3 provides additional prognostic 

information to t(4;14) in myeloma 

induction and consolidation therapy. 


84


Committee Report 

In CLL5, (Stephen Mulligan’s 

phase II study of oral fludarabine 

and cyclophosphamide combined 

with rituximab in elderly patients), 

analyses include fluorescent in 

situ hybridisation, baseline IgG 

subfractions and rituximab levels. 

Minimal residual disease monitoring 

by flow cytometry will be a component 

of David Gottlieb’s and Con Tam’s 

CLL6 phase III trial that compares 

lenalidomide consolidation with no 

consolidation in CLL patients with 

residual disease following induction 

fludarabine/cyclophosphamide/ 

rituximab chemoimmunotherapy. 

Rod Hicks and Mark Hertzberg’s 

NHL21 study of risk-adapted therapy 

for high-risk DLBCL is accruing rapidly. 

Diagnostic tissue and sequential 

peripheral blood samples are being 

collected. A number of correlative 

studies are ongoing, and preliminary 

functional immunological data in 

particular, looks promising. Continuing 

with NHL, the LS15 study of David 

Ritchie’s is examining regulatory 

T-cells in patients with follicular 

lymphoma receiving rituximab. LS14 

is another stand-alone study, involving 

researchers at Westmead, Peter 

MacCallum, Princess Alexandra and 

the Queensland Institute of Medical 

Research, that is investigating viral 

and immune biomarkers in a range 

of virus associated lymphomas in 

the immunosuppressed and overtly 

immunocompetent. It commenced 

in 2007, and continues to be a very 

productive collaboration. In advanced 

Hodgkin Lymphoma, the RATHL 

study (driven by Judith Trotman and 

Leanne Berkahn), aims to test the 

utility of sequential serum samples in 

conjunction with centralised PET/CT as 

disease response biomarkers. The trial 

has been amended to allow a third 

serum sample collected at a late timepoint, 

to test overseas serum samples, 

and to include an economic evaluation 

of risk-adapted therapy. 

With acute lymphoblastic leukaemia, 

there are several exciting new 

proposals involving Ken Bradstock’s 

ALL6 trial for young adults, which 

will hopefully be commencing soon. 

These involve a comparison of flow 

cytometry with traditional (molecular) 

methods of disease monitoring 

at defined time-points, as well 

as establishment of ALL 

murine xenografts. 

Under the guidance of Tim Hughes, 

the swathe of CML translational 

studies continues abated, with a 

strong emphasis on quantitative PCR 

to measure the depth and rapidity of 

molecular response to first and second 

generation tyrosine kinase inhibitors, 

as well as markers of resistance 

and drug levels. Of particular note 

is an innovative proposal by David 

Ross to use a peptide based vaccine 

in HLA-A2 CML patients to maintain 

complete molecular remission without 

concomitant TKI therapy. If successful, 

this study would represent a genuine 

paradigm shift in the management of 

this condition. 

The area of acute myeloid leukaemia 

has been particularly active. Lynda 

Campbell, with support of key 

stakeholders, continues the push 

towards a centralised cytogenetics 

review. This initiative will have 

ramifications beyond the ALLG’s trial 

activity, and she is to be applauded 

for her tenacity. Russell Saal has all 

but completed WT1 testing in AML 

M12 tissue banked samples, and with 

the assistance of colleagues at the 

Centre for Biostatistics and Clinical 

Trials at the Peter MacCallum, is now 

in the process of correlating data with 

clinical outcome. In conjunction with 

Paula Marlton he is also involved in 

minimal residual disease monitoring 

(including FLT3 and cKIT mutation 

analysis) in AML M13 samples. The 

first round of FLT3 standardisations 

between inter-state laboratories are 

complete, with the second round due 

for completion in 2012. Continuing 

the FLT3 theme, is Andrew Wei’s AML 

M16 phase II randomised FLT3-ITD 

positive sorafenib trial, whilst Harry 

Illand and colleagues are assessing 

outcome of patients enrolled into the 

completed APML3 study as a function 

of FLT3 mutations. Frank Firkin, in 

collaboration with ANU is measuring 

arsenic metabolite levels and relevant 

SNPs, in combination with toxicity and 

outcome data in the completed APML4 

study of arsenic combined with ATRA 

and idarubicin as first line therapy 

for APML. Underpinning all of the 

developments in AML is M18, 

a ground-breaking proposal 

by Andrew Wei to set up a common 

entry portal for patients with newly 

diagnosed AML, pending stratification 

into an appropriate trial (particularly 

M15 and M16). This will provide 

a large body of data over time, linked 

to tissue bank samples, cytogenetic 

and molecular data, and could 

potentially be linked to future AML 

studies including APML. This model, 

if successful, has potential 

implications for all ALLG trial based 

disease activities, and we wish Andrew 

every success with his initiative. 

Finally, in this my first year as 

LSC Chair, I should like to end on 

a personal note by thanking Joy 

Ho, whose wisdom and dedication 

provided the committee with excellent 

stewardship for many years. Thanks 

also for the hard work and support 

of all LSC members, and to the ALLG 

membership for their continuing 

accrual towards laboratory studies. 


Chair 

85

Laboratory Science Studies 

ls09 

Profiling dynamics of EBV-specific cytotoxic T-cell response in Hodgkin Lymphoma 

and its implication for immunotherapy. 


A/Prof Rajiv Khanna 

2011 status 

Sample acquisition 

and sample analysis 

Functional reversion of antigenspecific 

CD8+ T cells from patients 

with Hodgkin Lymphoma following 

in vitro stimulation with recombinant 

polyepitope. 

Recent studies on Hodgkin Lymphoma 

(HL) have indicated that patients with 

active disease display functional 

impairment of antigen-specific CD8+ 

T-cells due to expansion of regulatory 

T-cells at sites of disease and in the 

peripheral blood. Adoptive cellular 

immunotherapy based on Epstein-Barr 

virus (EBV)-specific CD8+ T-cells has 

been explored with limited success 

to date. It has been proposed that 

improved targeting of these CD8+ 

T-cells towards viral antigens which 

are expressed in HL may enhance 

future therapeutic vaccine strategies. 

Here we have developed a novel 

replicationdeficient adenoviral 

antigen presentation system which is 

designed to encode Glycine-Alanine 

repeat deleted EBV nuclear antigen 

1 (EBNA1ΔGA) covalently linked to 

multiple CD8+ T-cell epitopes from 

latent membrane proteins (LMP) –1 

and –2. A single stimulation of CD8+ 

T-cells from healthy virus carriers and 

patients with HL with this adenoviral 

construct in combination with IL–2 

was sufficient to reverse the functional 

T-cell impairment and restored 

both IFN-γ production and cytolytic 

function. More importantly, these 

activated CD8+ T-cells responded to 

tumour cells expressing LMP proteins 

and recognized novel EBNA1 epitopes. 

Flow cytometric analysis revealed that 

a large proportion of T-cells expanded 

from patients with HL were CD62Lhi 

and CD27hi and CCR7lo, consistent 

with early-mid effector T-cells. 

These findings provide an important 

platform for translation of antigenspecific 

adoptive immunotherapy 

for the treatment of EBV associated 

malignancies such as HL and 

nasopharyngeal carcinoma. 

Galectin-1 mediated suppression 

of EBV-specific T-cell immunity 

in classical Hodgkins Lymphoma 

In HL, the malignant Hodgkin Reed- 

Sternberg (HRS) cells interact with 

the host microenvironment to create 

an immunosuppressive network that 

protects the lymphoma from immune 

attack. These mechanisms are not 

fully understood. We examined the 

role of the immunomodulatory protein 

galectin-1 (Gal-1) on EBV-specific 

CD8+ T-cell responses in HL. Initial 

studies indicated Gal-1 expression 

in all in-vitro established HRS celllines. 

In-situ analysis revealed Gal-1 

expression in 26 of 42 classical HL 

(cHL), while Gal-1 was uniformly 

negative in nodular lymphocyte 

predominant HL. Gal-1hi expression 

was associated with male gender, 

older patients, reduced CD8+ T-cell 

infiltration at the tumour site and 

most importantly an impaired latent 

membrane protein 1 & 2-specific CD8+ 

T-cell responses. In-vitro exposure 

to recombinant Gal-1 inhibited 

proliferation and IFN-γ expression 

by EBV-specific T-cells. These 

observations provide an important 

link between the Gal-1-mediated 

immunomodulatory networks and 

loss of antigen-specific T-cell function 

in cHL. 


86


ls12 

A phase II trial in patients with previously untreated acute promyelocytic leukaemia 

to evaluate the effects of: (i) adding arsenic trioxide to all-trans retinoic acid and 

idarubicin for remission induction, and (ii) adding arsenic trioxide to all-trans 

retinoic acid as consolidation. 


A/Prof Harry Iland 

2011 status 



Accrual is continuing for patients 

with de novo APL. By December 2007, 

68 patients had been registered of 

which 66 were eligible. There has 

been one early death (on day one 

of the protocol). Compliance with 

the requirements for centralised 

molecular monitoring has been very 

satisfactory. All assays for patients 

with bcr1 and bcr3 breakpoints are 

performed by quantitative RT-PCR 

(Ipsogen FusionQuant). Assays for 

patients with bcr2 breakpoints are 

performed by qualitative semi-nested 

RT-PCR with a sensitivity of at least 10–4. 

Of 51 patients who are assessable for 

molecular response after induction, 

30 had achieved a molecular 

remission (59%), and 21 (41%) had 

residual detectable PML-RARA 

transcripts. In the previous APML3 

trial, 70% of patients were still RT-PCR 

positive after induction (p


ls13 

Wt-1 expression levels as a marker of Minimal Residual Disease (MRD) in AML. 


A/Prof Paula Marlton, 

Mr Russell Saal 

2011 status 



Sample collection is proceeding 

as part of the AMLM12 trial and 

independent of the trial at PAH. 

58 peripheral blood samples have 

been tested for Wt-1 transcript levels 

at diagnosis. Overexpression was 

confirmed in 89% of cases. Diagnostic 

levels have been correlated with 

overall survival. Increasing levels 

of Wt-1 correlated with poorer 

survival within cytogentic risk group. 

Sample collection and MRD testing is 

continuing and will be correlated with 

outcome. No interim analysis has been 

performed at this stage. 


88


ls14 

Immune and viral biomarkers as tools to assist clinical outcome in patients with 

EBV-positive lymphomas. 



2011 status 



EBV infects more than 90% of the 

human population before adulthood. 

Life-long persistence involves a 

balance between viral biology and 

host immunity. Although usually 

without adverse health consequences, 

the virus is aetiologically linked with 

a spectrum of disorders including 

epithelial and lymphoid malignancies. 

EBV-positive lymphomas cover diverse 

histological subtypes depending on 

host immunity, all characterized by 

the presence of EBV-DNA within the 

malignant cells. Emerging evidence 

indicates immunopathogenesis in 

both immunosuppressed and overtly 

immunocompetent patients. 

The localisation of EBV within 

lymphoma cells provides several 

opportunities: firstly it may serve 

as a highly specific biomarker 

of efficacy in patients receiving 

conventional non-targeted therapies; 

secondly it can act as a potential 

target for cellular immunotherapy. 

The hypothesis to be tested is 

that immunoregulatory and viral 

biomarkers are a powerful tool in 

the clinical management of patients 

with EBV-positive lymphomas. 

The data generated will assist the 

rationale design of EBV targeted 

immunotherapies. 

To achieve these objectives, we are 

performing a prospective, multicentre, 

observational study. All centres 

that treat lymphoma are welcome. 

Lymphoma sub-types to be included 

are: Hodgkins lymphoma, PTLD, 

ENKTL, methotrexate-associated 

NHL, primary and secondary immune 

deficiency associated lymphomas, 

peripheral T-cell lymphoma 

unspecified, Burkitt, Lymphomatoid 

Granulomatosis, and AITL. Any other 

lymphoproliferative disorder in which 

EBV may be implicated including 

Chronic Active EBV patients and 

certain cases of DLBCL will also be 

eligible. Patients are to be accrued 

irrespective of EBV serological or 

EBER-ISH status (Patients who are 

negative serve as controls). 

The study commenced accrual 

in 2007. 

89


ls15 

Regulatory T-cells in patients with follicular lymphoma receiving Rituximab, 

scientific sub-study to NHL-14. 


Dr Saar Gill, A/Prof David Ritchie 

2011 status 

Immunologic monitoring 

of patients with 

follicular lymphoma 

receiving rituximab 

Aim of this study 

To examine whether the 

administration of rituximab in patients 

with follicular lymphoma leads to 

alterations in circulating Treg numbers 

and function. 

We hypothesise: 

That PB Treg numbers (as a proportion 

of total T cells) will be proportional to 

Treg numbers in biopsies of lymphoma 

lymph node 

(a) That peripheral blood (PB) Treg 

numbers will fall in those patients 

treated with rituximab when 

compared with baseline (and 

compared to those in the control 

arm) 

(b) That the degree of Treg reduction 

will reflect the degree of clinical 

response 

(c) That Treg reduction will limit 

suppression of CD8 T-cell and CD4 

T-cell function in patients receiving 

rituximab compared to control 

patients 

(d) That time to disease progression 

will be shorter in those that have 

less reduction in Treg numbers 

Methods 

Peripheral blood will be collected 

at baseline, and at week 2, 4, 12 

and 52 (or progression as defined 

by NHL-14, whichever occurs first). 

The samples will be batched and 

analysed for regulatory T cell number 

(by flow cytometry) and function (by 

suppressor assays). Results will be 

compared to healthy controls. 

In addition, paraffin sections of the 

diagnostic tumour biopsy will be 

forwarded to the above address for 

fluorescent microscopic analysis of 

regulatory T cell number in relation 

to tumour cells. 

Statistical Analysis 

Associations between regulatory T cell 

number and clinical end points will be 

tested. Comparison between treated 

and untreated patients, and rituximab 

responders and non-responders, will 

be analysed using the Student’s T 

test for difference in the median Treg 

number and proportion of total T cells. 

Samples 

All samples sent for the laboratory 

sub-study will be de-identified. Each 

sample will be identified by a unique 

patient identifier and time of sample 

as per NHL-14,(e.g. week 4) as well 

as the time and date of collection 

and the participating hospital. The 

baseline tumour biopsy sections may 

be couriered separately if they are 

not available at the time of collection 

of the patient’s blood. Nine unstained 

slides containing one paraffin wax 

section will be forwarded to the 

PMCC laboratory. At each specified 

time point, a total of 30mL peripheral 

blood in lithium heparin tubes will be 

taken, kept at room temperature, and 

couriered overnight to PMCC. 


90


in the last 10 years

Trials closed to accrual 

in the last 10 years 


Page 

ALL2 96 

ALL3 96 

AMLM9 97 

AMLM10 97 

AMLM11 98 

AMLM12 98 

AMLM13 99 

APML3 99 

APML4 100 

CMLALL1 100 

MDS3 101 


BM02 102 



CML4 103 

CML5 103 

CML6 104 

CML7 104 



Page 

HD3 105 

HD4 105 

HD9 106 

HDNHL4 106 

LY02 107 

LY04 107 

LY05 108 

LY06 108 

NHL07 109 

NHL08 109 

NHL10 110 

NHL11 110 

NHL13 111 

NHL18 111 

NHL19 112 



CLL2 113 

LY03 113 

NHL14 114 

NHL16 114 

NHLLOW4 115 

Myeloma 

MM5 116 

MM6 116 

MM7 117 

MM8 117 

MM9 118 

Supportive care 

SC01 119 

95


ALL2 

LALA94 – Multicentre trial of induction and post remission therapy of adult acute 

lymphoblastic leukaemia. 




This is a complex trial examining several risk-stratified 

questions in induction and consolidation therapy 

for adult ALL. In the induction phase, there was 

a comparison of the anthracyclines Daunorubicin 

and Idarubicin on survival. In post remission therapy, there 

was a comparison of duration of remission and survival 

comparing several cell sources for bone marrow transplant. 

Trial status: Published 


Accrual target (international): 1,000 

Accrual target (ALLG): Not specified 

Final accrual (international): 1,000 






all3 

A phase II study of induction therapy using idarubicin and infusional high dose 

cytarabine for adult patients with de novo untreated acute lymphoblastic leukaemia. 





To assess the toxicity of combination chemotherapy 

with infusional high dose cytarabine and Idarubicin 

in previously untreated patients aged 20 to 55 years 

with precursor-B ALL. 








Reason for closure: Excessive toxicity 


Pharmion 


96


Amlm9 

A phase I–II study of idarubicin dose escalation in combination with infusional 

high dose cytarabine in patients with untreated adult acute myeloid leukaemia. 



Dr John Catalano 



To investigate the maximum tolerated dose of idarubicin 

when used in induction therapy with infusion high 

dose cytarabine. 

Trial status: Unpublished 







Reason for closure: Toxicity 


Pharmacia 

amlm10 

A phase II study of flexible low intensity combination chemotherapy (FLICC) 

for elderly patients (>60yrs) with acute myeloid leukaemia. 


Dr Arumugam Manoharan 


To evaluate the efficacy and toxicity of a flexible low 

intensity chemotherapy regimen (using cytarabine, 

mitozantrone and etoposide) in patients over 60 years 

of age with untreated AML. 









97


Amlm11 

Non-myeloablative allogeneic stem cell transplantation (NMSCT) in adults with 

intermediate and adverse prognosis AML in first complete remission. 




To evaluate the kinetics of T-cell and myeloid chimerism in 

patients with intermediate and poor prognosis AML in first 

complete remission (CR1) receiving two different NMSCT 

conditioning regimens (fludarabinecyclophosphamide and 

fludarabine-melphalan) and to relate chimerism to the 

incidence and severity of graft versus host disease (GVHD). 


Date study opened: May 2001 








Schering-Plough 

AMLM12 

A placebo-controlled, randomised trial of the effect of palifermin on severe oral 

mucositis following intensive induction chemotherapy incorporating high dose 

cytarabine and a randomised trial of idarubicin dose escalation in consolidation 

therapy in patients with untreated adult acute myeloid leukaemia. 





To determine if Palifermin, given intravenously as three 

doses of 60µg/kg per day before and three doses after ICE 

chemotherapy, will reduce the incidence of grades 3 and 4 

oral mucositis. 

To determine whether intensified therapy with idarubicin 

during consolidation therapy can improve leukaemia-free 

survival in patients less than 60 years of age with newly 

diagnosed AML who have achieved a complete remission 

with ICE induction chemotherapy. 

Trial status: Pending main analysis 2012 


Accrual target (ALLG): Induction (Palifermin) trial: 

256 patients to be randomised 

Consolidation trial: 288 patients to be randomised 

(425–445 registered) 







Pfizer 


98


AMLM13 

High dose cytosine arabinoside and fludarabine without anthracycline for core 

binding factor AML. 


A/Prof Paula Marlton 




To establish failure free survival and overall survival in 

patients with CBF AML treated with HiDAC and fludarabine 

without anthracyclines. To estimate CR rate, leukaemia 

free survival, safety and tolerability. To study MRD by QPCR, 

FISH and flow. 









Pharmaceutical company support: Amgen Australia 

Apml3 

A phase II trial of ATRA and intensive idarubicin followed by molecular monitoring 

in patients with acute promyelocytic leukaemia. 




Dr James Wiley 

Dr Frank Firkin 


To maximise the complete remission rate by combining 

all-trans retinoic acid (ATRA) with intensive idarubicin 

chemotherapy, to minimise relapse rate by employing 

a second course of idarubicin followed by intermittent ATRA 

for eradication of minimal residual disease. 



Accrual target (ALLG): 100 eligible patients 






Pharmaceutical company support: Pharmacia 

99


apml4 

Arsenic oxide combined with ATRA and Idarubicin as first line therapy for acute 

promyelocytic leukaemia. 



A/Prof Frank Firkin 

Prof Peter Browett 


To evaluate in a group of patients with de novo APL the 

effect of a chemotherapy protocol consisting of arsenic 

trioxide added to standard induction (ATRA plus intensive 

idarubicin) and two cycles of consolidation (ATRA plus 

arsenic trioxide) on time to molecular relapse. 

To assess the effect of obligatory use of prednisone 

(or prednisolone) and aggressive haemostatic support, 

during induction, on early death rate. 

Trial status: Pending final analysis 2012 








Pharmaceutical company support: Phebra 

CMLALL1 

A phase II pilot study of Glivec (STI571) combined with induction chemotherapy 

in blast-phase chronic myeloid leukaemia and Philadelphia chromosome-positive 

acute lymphoblastic leukaemia. 



Dr Jason Lickliter 


Investigate the safety and tolerability of Glivec 

in combination with induction chemotherapy 

for blast phase CML and Ph+ ALL. 








Reason for closure: Inadequate accrual 



100


MDS3 

A Phase I/II trial of combination therapy with 5-azacytidine (Vidaza) and Thalidomide 

in patients with Myelodysplastic Syndromes (MDS). 


Dr Melita Kenealy 



Demonstrate safety and tolerability of the combination 

of thalidomide and 5-azacitidine in MDS. 










101


BM02 

Pamidronate post allogeneic bone marrow transplantation. 




To assess whether pamidronate prevents loss of bone 

density after allogeneic BMT. 

Comments 

BM02 trial accrued 120 patients at 5 sites between 1999 

and 2002, and this randomised study demonstrated that 

a bisphosphonate markedly reduced post-allograft bone 

mineral density in the first 12 months, particularly in 

patients on high doses of immunosuppression. 











102



cml4 

Pilot study to determine the efficacy and safety of Glivec ® (STI571) alone and Glivec ® 

(STI571) plus Intron A in the early recovery phase post autologous blood or marrow 

transplant for advanced phase chronic myeloid leukaemia and Ph-positive acute 

lymphoblastic leukaemia. 



Dr Chris Arthur 



To assess the safety of Glivec® STI571 

in the early post autograft setting. 


1. Assess haematological, cytogenetic and molecular 

response to Glivec® post autograft. 

2. Assess safety and efficacy of Glivec® in combination with 

Intron A post autograft. 

3. Assess on-time delivery of Glivec®. 

Trial status: Final report complete, pending publication 








Pharmaceutical company support: Novartis Australia, 

Amgen Australia 

cml5 

A phase II study of efficacy and safety of Glivec ® in patients with chronic 

myeloid leukaemia and complete or near complete cytogenetic response 

to interferon-alpha therapy. 


A/Prof Kerry Taylor 


1. To assess whether switching these patients to Glivec® 

improves response when assessed at a molecular level. 

2. To assess the safety of treatment with Glivec® in such 

CML patients who have had prolonged stable complete 

or near complete response to interferon-therapy. 








Reason for closure: Completed accrual 


103



cml6 

A phase II study in adult patients with newly-diagnosed chronic myeloid leukaemia 

of initial intensified Glivec ® therapy and sequential therapy for non-responders. 





To assess overall rates and duration of complete 

cytogenetic repsonse and molecular response achieved 

using a schedule of intensive, escalated and combination 

therapy with Glivec®, in association with Figrastim support, 

in adults with newly diagnosed chronic phase CML over 

a two year period. 

Trial status: Treatment phase published. Extension phase 

continues. 










cml7 

Phase II trial of Pegasys in Glivec ® responsive chronic myeloid leukaemia. 


A/Prof Kerry Taylor 


Primary Objective: 

To assess whether adding Pegasys to Glivec ® in these 

patients improves molecular response status. 

Secondary Objective: 

To assess the safety of treatment with Pegasys in such 

CML patients, who have had complete or near complete 

cytogenetic. 








Reason for closure: Met revised target accrual 


Roche Australia 


104



hd3 

An ANZLG/TROG prospective study of limited chemotherapy and involved field 

radiotherapy for patients with clinical stage I–II Hodgkin disease. 




To estimate 3 and 5 year progression-free survival after 

3 (4) cycles of ABVD and IFRT in patients with early stage 

Hodgkin Disease. 










hd4 

BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) 

in stage III & IV Hodgkin lymphoma. 


Dr Max Wolf 


1. To assess whether BEACOPP (4 esc. + 4 baseline) 

improves event free survival compared to 8 cycles ABVD 

in stage III/IV HD with IPS 3 or higher. 

2. Primary endpoint is event free survival. 

3. Secondary endpoints are: complete remission, diseasefree 

survival, overall survival, quality of life, occurrence 

of second malignancies. 

Comments 

An international collaboration with the EORTC 

Lymphoma Group. 

Trial status: Final analysis and publication expected 2012 




Final accrual (international): 550 







105



hd9 

Long-term follow-up of Hodgkin Lymphoma survivors: An Australian and 

New Zealand patterns of care study. 


Dr Eng-Siew Koh 


The primary objective is to describe current patterns 

of care of ‘long-term’ *survivors of Hodgkin lymphoma 

across Australia and New Zealand. [* For the purposes of 

this study, we have defined ‘long-term survivors’ as those 

patients who are five years or more after their primary 

diagnosis of lymphoma.] 



Accrual target (ALLG): No limit on clinician participation 


Date study closed to accrual: 2010 

hdnhl4 

An ALLG/TROG prospective multicentre study of involved-field radiotherapy with 

transplantation for patients with Hodgkin’s disease and non-Hodgkin’s lymphoma. 



A/Prof H. Miles Prince 


Determine the cumulative incidence of progression 

in pre-transplant relapse sites 3 years following 

commencement of treatment. 








Reason for closure: Slow patient accrual 


Baxter Healthcare 


106



ly02 

A prospective, non-randomised study of chemotherapy and radiotherapy 

for osteolymphoma. 


Dr David Christie 


To optimise overall survival, determine prognostic factors, 

avoid pathologicalfractures and study natural history. 









ly04 

A phase II study of idarubicin-based combined modality therapy in primary central 

nervous system lymphoma. 


Dr Peter O’Brien 



Phase II study of Idarubicin and Methotrexate combined 

with low-dose cerebral irradiation. Primary endpoint is 

overall survival. 

Trial status: Pending publication 








Pharmaceutical company support: Pfizer 

107



ly05 

A phase II randomised study to assess the response of fludarabine in combination 

with cyclophosphamide vs fludarabine in combination with cyclophosphamide 

and Mabthera in patients with untreated mantle cell lymphoma. 


Dr Simon Rule (UK) 

Prof John Seymour (ALLG) 


This is a phase II randomised study to assess the response 

of fludarabine in combination with cyclophosphamide 

in patients with untreated mantle cell lymphoma. The 

randomisation is for the addition or not of Mabthera 

to this regimen. 


Date study opened: August 2002 









Pharmaceutical company support: Roche Australia, 

Schering-Plough 

ly06 

A clinicopathological study in Burkitt’s and Burkitt-Like non-Hodgkin’s lymphoma. 


Prof Max Wolf 


1. To assess the activity of CODOX-M/IVAC using a lower 

dose of methotrexate (compared to the UKLG LY06 Trial) 

of 3g/m² in a phase II study in adult sporadic BL and 

Burkitt-like lymphoma. 

2. To further assess the activity of these regimens 

in patients with leukaemic BL and by modifying 

chemotherapy doses, to include older patients often 

excluded from clinical trials. 




Accrual target (ALLG): Not specified 








108



nhl07 

Phase III randomised trial of high-dose CEOP chemotherapy and Filgrastim versus 

standard dose CEOP in patients with non-Hodgkin’s lymphoma. 


Prof Max Wolf 


Comparison of dose intensity in treatment 

of intermediate/high grade NHL. 

Trial status: Manuscript under preparation 









Pharmacia 

nhl08 

Trial to evaluate early high dose therapy (HDCT) and autologous bone marrow 

transplantation (ABMT) as part of planned initial therapy for poor risk intermediate 

grade non-Hodgkin lymphoma. 


Dr Joe McKendrick 


To compare elective auto transplantation in first remission 

with standard chemotherapy in patients with poor 

prognosis intermediate grade NHL. 

Trial status: Undergoing analysis 









109



nhl10 

Randomised intergroup trial of first line treatment for patients with diffuse large-cell 

non-Hodgkin lymphoma with a CHOP-like chemotherapy regimen with or without 

the anti-CD20 antibody Rituximab (IDEC-C2B8). 


Prof David Ma 

A/Prof Devinder Gill 


To evaluate the efficacy and tolerability of addition 

of CD20 antibody to standard combination chemotherapy 

in untreated patients with intermediate grade NHL 

with low IPI. 











Pharmaceutical company support: Roche Australia 

nhl11 

A phase II study of a modified ‘Hyper-CVAD’ frontline therapy for patients with poor 

prognosis diffuse large B-cell and peripheral T-cell non-Hodgkin lymphoma. 



A/Prof Paula Marlton 


Primary endpoint is complete remission rate (CR and CRu) 

using International Workshop criteria. Will compare this 

with anticipated rate (stratified for immunophenotype and 

IPI score). Also analyse 2 year PFS and OS as well as safety. 

Trial status: Undergoing final analysis 








Pharmaceutical company support: Mayne Pharma, 



110



nhl13 

Randomised study of ICE plus Rituximab (R-ICE) vs DHAP plus Rituximab (R-DHAP) in 

previously treated patients with CD20 positive diffuse large B-cell lymphoma, eligible 

for transplantation followed by randomised maintenance treatment with Rituximab. 



Dr David Ma 


Part I, induction therapy: To evaluate the efficacy and the 

safety of ICE plus rituximab (R-ICE) in comparison with 

DHAP plus rituximab (R-DHAP) in previously-treated 

patients with CD20-positive large B-cell lymphoma 

eligible for autologous transplantation. 












Roche NZ, Baxter Healthcare 

nhl18 

A multicentre, randomised Phase III Study of Rituximab as maintenance treatment 

versus observation alone in patients with aggressive B-cell lymphoma. 


Dr David Goldstein 


To evaluate the clinical efficacy of rituximab maintenance 

therapy as compared to observation in patients with 

aggressive B-cell Non-Hodgkins lymphoma or follicular 

lymphoma grade 3b who have achieved a complete 

remission after appropriate first-line therapy, measured 

by event-free survival (EFS). 

Comments 

An international collaboration with AGMT NHL13 

study, Austria. 












111



nhl19 

Follow up observational study of the randomised intergroup trial of first line treatment 

for patients with diffuse large B-cell NHL with a CHOP-like chemotherapy regimen 

with or without the anit-CD20 antibody Rituximab. 




To collect data on failure-free and overall survival as 

well as long-term toxicity of patients with diffuse large 

B-cell lymphoma previously treated within the MInT study 

(NHL10) with or without Rituximab in combination with a 

standard CHOP-like chemotherapy regimen. 










Reason for closure: Reached the end of the follow-up period 



112



cll2 

International Phase III-Trial in B-cell CLL. Intermediate-dose 

chlorambucil vs cladribine vs fludarabine. 




Analysis of first-line therapy in B-cell CLL. 











Pharmaceutical company support: Janssen-Cilag 

ly03 

A randomised trial of chlorambucil vs fludarabine as initial therapy of Waldenström's 

macroglobulinaemia and splenic lymphoma with villous lymphocytes. 




Determine the cumulative incidence of Randomised 

comparison of chlorambucil 8mg/m2/d x 10 d q 28d, 

versus fludarabine 25mg/m2 IV daily x 5, q 28d as the first 

systemic cytotoxic therapy for patients with Waldenström’s 

macroglobulinemia, SLVL or lymphoplasmacytic NHL. 

Primary endpoint is response to therapy and duration of 

response. 

Trial status: Manuscript complete, pending publication 










Pharmaceutical company support: Schering-Plough 

113



nhl14 

An intergroup randomised trial of rituximab versus a watch and wait strategy 

in patients with advanced stage, asymptomatic, non-bulky follicular lymphoma 

(Grades 1, 2 and 3a). 




A randomised phase III trial to determine 

whether initial treatment with rituximab in patients with 

advanced stage asymptomatic follicular lymphoma (grades 

1, 2 and 3a) results in a significant delay in the initiation 

of chemotherapy or radiotherapy and the impact of each 

strategy on patient-related quality of life. 

Trial status: In follow-up 










Pharmaceutical company support: Roche 

nhl16 

A multicentre, phase III, open-label, randomised study in patients with advanced 

follicular lymphoma evaluating the benefit of maintenance therapy with Rituximab 

after induction of response with chemotherapy plus Rituximab in comparison with 

no maintenance therapy (PRIMA). 




Event Free Survival (EFS) defined as the time from 

randomisation to progression, relapse, death 

from any cause, or requirement of a new treatment 

whatever the reason. 



Accrual target (international): 1,200 


Final accrual (international): 1,200 





Reason for closure: Completed accrual 


Roche NZ 


114



nhllow4 

Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and 

maintenance treatment of relapsed follicular non-Hodgkin lymphoma: a phase III 

randomised clinical trial – intergroup collaborative study (EORTC 20981). 


Prof Max wolf 


Randomised study of CHOP +/– Mabthera. The objectives 

are to determine the effect of addition of MabThera to CHOP 

in relapsed low-grade NHL on response and to determine 

the effect of maintenance MabThera on progression-free 

survival. 










Reason for closure: Objectives achieved 


Roche NZ 

115

Myeloma 

mm5 

A pilot study of melphalan 220mg/m2 and amifostine cytoprotection as conditioning 

for autologous stem cell transplantation in patients with multiple myeloma. 




1. To evaluate the haematological and non-haematological 

toxicity of melphalan 220mg/m2 and amifostine 

cytoprotection in multiple myeloma patients 

undergoing an initial ASCT. 

2. To determine the CR rate using melphalan 220mg/m2 

with amifostine cytoprotection in multiple myeloma 

patients undergoing an initial ASCT. 









Pharmaceutical company support: Schering-Plough, 


mm6 

A multicentre randomised phase III study of low-dose thalidomide, prednisolone and 

zoledronic acid versus prednisolone and zoledronic acid for post-asct maintenance 

therapy in patients with multiple myeloma. 




Evaluate role of low-dose thalidomide as maintenance 

following ASCT. 



Accrual target (ALLG): 224 evaluable patients 







Schering-Plough, Pharmion 


116

Myeloma 

mm7 

A multicentre phase II study of the safety and efficacy of thalidomide post-allogeneic 

stem cell/bone marrow transplantation in multiple myeloma. 


Prof John Gibson 

Prof Doug Joshua 


To determine safety of thalidomide as post allotransplant 

consolidation and maintenance therapy. 










mm8 

A Phase II Study of Risk-Adapted IV Melphalan in AL Amyloidosis. 


Dr Peter Mollee 


To determine the proportion of patients who achieve a 50% 

reduction in serum free light chains at six months following 

therapy with intravenous melphalan. 








Reason for closure: Slow patient accrual 


117

Myeloma 

mm9 

A three-stage phase I/II dose-escalation study of high-dose melphalan with 

palifermin for patients with multiple myeloma. 




To determine the maximum tolerated dose of intravenous 

melphalan when used in combination with palifermin for 

the treatment of myeloma patients who fail to achieve 

complete remission with pre-ASCT induction therapy. 

To determine the complete response rate achieved with 

the MTD of intravenous melphalan when it is used in 

combination with palifermin for the treatment of MM 

patients who fail to achieve either 1) partial remission or 2) 

complete remission with pre-ASCT induction therapy. 

To characterise the rate of neutrophil engraftment following 

high-dose melphalan conditioned ASCT in patients with MM 

being treated with palifermin. 

Trial status: Closed 







Reason for closure: Toxicity 

Pharmaceutical company support: Amgen supplied 

Palifermin and Pegfilgrastim 


118


sc01 

Multicentre randomised controlled clinical trial comparing two strategies for the 

diagnosis of invasive aspergillosis in high-risk haematology patients (ASPID study). 


Dr Monica Slavin 

Dr Orla Morrissey 


Primary outcome: 

Proportion of patients treated with empiric antifungal 

therapy (EAFT). 

Secondary outcomes: 

Invasive Aspergillosis-related mortality, other invasive 

fungal infection-related (IFI) mortality, all cause mortality, 

mean number of hospital admissions, hospital length 

of stay, total duration of antifungal therapy, nephrotoxicity 

rates, hepatotoxicity rates, number of courses of EAFT, 

mean number of invasive procedures performed 

to diagnose IA and cost data associated with treatment 

and complications. 

Trial status: Analysis complete, pending publication 







Reason for closure: Slow accrual; Interim analysis 

number achieved 

Pharmaceutical company support: Merck Sharp & 

Dohme, Schering-Plough, Gilead 

119


120

Publications, Presentations 

and Abbreviations

Publications 

ALLG Publications 

Trial Title Citations 

2011 

LY02 

LS13 

APML3 

SC01 

NHL10 

NHL10 

NHL16 

NHL16 

Christie, D., Dear, K., Le, T., Barton, M., Wirth, A., Porter, D., Roos, D. and Pratt, G. (2011) Limited Chemotherapy 

and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans- 

Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective 

Trial. Int J Radiat Oncol Biol Phys 80(4): 1164–1170. 

Gray, J. X., McMillen, L., Mollee, P., Paul, S., Lane, S., Bird, R., Gill, D., Saal, R. and Marlton, P. (2011) WT1 

expression as a marker of minimal residual disease predicts outcome in acute myeloid leukemia when 

measured post-consolidation. Leuk Res (in print). 

Iland, H. J., Bradstock, K., Seymour, J., Hertzberg, M., Grigg, A., Taylor, K., Catalano, J., Cannell, P., Horvath, N., 

Deveridge, S., Browett, P., Brighton, T., Li, C., Springall, F., Ayling, J., Catalano, A., Supple, S., Collins, M., Di Iulio, J. 

and Reynolds, J. (2011) Results of the APML3 trial incorporating all-trans-retinoic acid and idarubicin in both 

induction and consolidation as initial therapy for patients with acute promyelocytic leukemia. Haematologica 

(in print). 

Morrissey, C. O., Chen, S. C., Sorrell, T. C., Bradstock, K. F., Szer, J., Halliday, C. L., Gilroy, N. M., Schwarer, A. P. and 

Slavin, M. A. (2011) Design issues in a randomized controlled trial of a pre-emptive versus empiric antifungal 

strategy for invasive aspergillosis in patients with high-risk hematologic malignancies. Leuk Lymphoma 52(2): 

179–193. 

Pfreundschuh, M., Kuhnt, E., Trumper, L., Osterborg, A., Trneny, M., Shepherd, L., Gill, D. S., Walewski, J., 

Pettengell, R., Jaeger, U., Zinzani, P. L., Shpilberg, O., Kvaloy, S., de Nully Brown, P., Stahel, R., Milpied, N., Lopez- 

Guillermo, A., Poeschel, V., Grass, S., Loeffler, M. and Murawski, N. (2011) CHOP-like chemotherapy with or 

without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an 

open-label randomised study of the MabThera International Trial (MInT) Group. Lancet Oncol 12(11): 1013–1022. 

Rieger, M., Osterborg, A., Pettengell, R., White, D., Gill, D., Walewski, J., Kuhnt, E., Loeffler, M., Pfreundschuh, 

M. and Ho, A. D. (2011) Primary mediastinal B-cell lymphoma treated with CHOP-like chemotherapy with or 

without rituximab: results of the Mabthera International Trial Group study. Ann Oncol 22(3): 664–670. 

Salles, G., Seymour , J. F., Offner, F., Lopez-Guillermo, A., Mege, L. and Tilly, H. (2011) Rituximab maintenance 

therapy for follicular lymphoma — Authors' reply. Lancet 377(9772): 1151–1152. 

Salles, G., Seymour, J. F., Offner, F., Lopez-Guillermo, A., Belada, D., Xerri, L., Feugier, P., Bouabdallah, R., 

Catalano, J. V., Brice, P., Caballero, D., Haioun, C., Pedersen, L. M., Delmer, A., Simpson, D., Leppa, S., Soubeyran, 

P., Hagenbeek, A., Casasnovas, O., Intragumtornchai, T., Ferme, C., da Silva, M. G., Sebban, C., Lister, A., Estell, 

J. A., Milone, G., Sonet, A., Mendila, M., Coiffier, B. and Tilly, H. (2011) Rituximab maintenance for 2 years in 

patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a 

phase 3, randomised controlled trial. Lancet 377(9759): 42–51. 

NHL10 Schmitz, N., Zeynalova, S., Glass, B., Kaiser, U., Cavallin-Stahl, E., Wolf, M., Haenel, M., Loeffler, M., Truemper, L. 

and Pfreundschuh, M. (2011) CNS disease in younger patients with aggressive B-cell lymphoma: an analysis 

of patients treated on the Mabthera International Trial and trials of the German High-Grade Non-Hodgkin 

Lymphoma Study Group. Ann Oncol (in print). 

NHL16 Trotman, J., Fournier, M., Lamy, T., Seymour, J. F., Sonet, A., Janikova, A., Shpilberg, O., Gyan, E., Tilly, H., Estell, 

J., Forsyth, C., Decaudin, D., Fabiani, B., Gabarre, J., Salles, B., Van Den Neste, E., Canioni, D., Garin, E., Fulham, 

M., Vander Borght, T. and Salles, G. (2011) Positron Emission Tomography-Computed Tomography (PET-CT) 

after induction therapy is highly predictive of patient outcome in follicular lymphoma: analysis of PET-CT in a 

subset of PRIMA trial participants. J Clin Oncol 29(23): 3194–3200. 

AMLM7 van der Jagt, A., Muirhead, J., Seymour, J. F., Bradstock, K. F., Paul, E. and Wei, A. (2011) Risk factors for early 

death after high-dose cytosine arabinoside (HiDAC)-based chemotherapy for adult AML. Leukemia (in print). 

HD3 Wirth, A., Grigg, A., Wolf, M., Goldstein, D., Johnson, C., Davis, S., Dutu, G., Kypreos, P., Smith, C., Kneebone, A., 

Herzberg, M., Joseph, D., Catalano, J., Roos, D., Stone, J. and Reynolds, J. (2011) Risk and response adapted 

therapy for early stage Hodgkin lymphoma: a prospective multicenter study of the Australasian Leukaemia 

and Lymphoma Group/Trans-Tasman Radiation Oncology Group. Leuk Lymphoma 52(5): 786–795. 

0 

– 

– 

0 

1 

5 

0 

0 

– 

0 

– 

1 

Publications 

123



2010 

LY02 

NHL13 

Christie, D., Dear, K., Le, T., Barton, M., Wirth, A., Porter, D., Roos, D. and Pratt, G. (2010) Limited Chemotherapy 

and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results from the Trans- 

Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective 

Trial. Int J Radiat Oncol Biol Phys 80(4): 1164–1170. 

Gisselbrecht, C., Glass, B., Mounier, N., Singh Gill, D., Linch, D. C., Trneny, M., Bosly, A., Ketterer, N., Shpilberg, 

O., Hagberg, H., Ma, D., Briere, J., Moskowitz, C. H. and Schmitz, N. (2010) Salvage regimens with autologous 

transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol 28(27): 4184–4190. 

NHLLOW1 Grigg, A. P., Stone, J., Milner, A. D., Schwarer, A. P., Wolf, M., Prince, H. M., Seymour, J., Gill, D., Ellis, D. 

and Bashford, J. (2010) Phase II study of autologous stem cell transplant using busulfan-melphalan 

chemotherapy-only conditioning followed by interferon for relapsed poor prognosis follicular non-Hodgkin 

lymphoma. Leuk Lymphoma 51(4): 641–649. 

NHL8 Linch, D. C., Yung, L., Smith, P., Maclennan, K., Jack, A., Hancock, B., Cunningham, D., Hoskin, P., Qian, W., Holte, 

H., Boesen, A. M., Grigg, A., Browett, P. and Trneny, M. (2010) Final analysis of the UKLG LY02 trial comparing 

6-8 cycles of CHOP with 3 cycles of CHOP followed by a BEAM autograft in patients



2008 

SC01 

CML6 

AMLM13 

Chang, C. C., Athan, E., Morrissey, C. O. and Slavin, M. A. (2008) Preventing invasive fungal infection during 

hospital building works. Intern Med J 38(6b): 538–541. 

Hughes, T. P., Branford, S., White, D. L., Reynolds, J., Koelmeyer, R., Seymour, J. F., Taylor, K., Arthur, C., 

Schwarer, A., Morton, J., Cooney, J., Leahy, M. F., Rowlings, P., Catalano, J., Hertzberg, M., Filshie, R., Mills, A. K., 

Fay, K., Durrant, S., Januszewicz, H., Joske, D., Underhill, C., Dunkley, S., Lynch, K. and Grigg, A. (2008) Impact 

of early dose intensity on cytogenetic and molecular responses in chronic- phase CML patients receiving 600 

mg/day of imatinib as initial therapy. Blood 112(10): 3965–3973. 

Lane, S., Saal, R., Mollee, P., Jones, M., Grigg, A., Taylor, K., Seymour, J., Kennedy, G., Williams, B., Grimmett, K., 

Griffiths, V., Gill, D., Hourigan, M. and Marlton, P. (2008) A >or=1 log rise in RQ-PCR transcript levels defines 

molecular relapse in core binding factor acute myeloid leukemia and predicts subsequent morphologic 

relapse. Leuk Lymphoma 49(3): 517–523. 

LY06 Mead, G. M., Barrans, S. L., Qian, W., Walewski, J., Radford, J. A., Wolf, M., Clawson, S. M., Stenning, S. P., Yule, C. 

L. and Jack, A. S. (2008) A prospective clinicopathologic study of dose-modified CODOX-M/IVAC in patients with 

sporadic Burkitt lymphoma defined using cytogenetic and immunophenotypic criteria (MRC/NCRI LY10 trial). 

Blood 112(6): 2248–2260. 

SC01 Morrissey, C. O., Bardy, P. G., Slavin, M. A., Ananda-Rajah, M. R., Chen, S. C., Kirsa, S. W., Ritchie, D. S. and Upton, 

A. (2008) Diagnostic and therapeutic approach to persistent or recurrent fevers of unknown origin in adult 

stem cell transplantation and haematological malignancy. Intern Med J 38(6b): 477–495. 

NHL10 Pfreundschuh, M., Ho, A. D., Cavallin-Stahl, E., Wolf, M., Pettengell, R., Vasova, I., Belch, A., Walewski, J., Zinzani, 

P. L., Mingrone, W., Kvaloy, S., Shpilberg, O., Jaeger, U., Hansen, M., Corrado, C., Scheliga, A., Loeffler, M. and 

Kuhnt, E. (2008) Prognostic significance of maximum tumour (bulk) diameter in young patients with goodprognosis 

diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an 

exploratory analysis of the MabThera International Trial Group (MInT) study. Lancet Oncol 9(5): 435–444. 

CML8 Ross, D. M., Watkins, D. B., Hughes, T. P. and Branford, S. (2008) Reverse transcription with random 

pentadecamer primers improves the detection limit of a quantitative PCR assay for BCR-ABL transcripts in 

chronic myeloid leukemia: implications for defining sensitivity in minimal residual disease. Clin Chem 54(9): 

1568–1571. 

– Slavin, M. A. (2008) Introduction to the updated Australian and New Zealand consensus guidelines for the use 

of antifungal agents in the haematology/oncology setting, 2008. Intern Med J 38(6b): 457–467. 

SC01 Slavin, M. A., Heath, C. H., Thursky, K. A., Morrissey, C. O., Szer, J., Ling, L. M., Milliken, S. T. and Grigg, A. P. (2008) 

Antifungal prophylaxis in adult stem cell transplantation and haematological malignancy. Intern Med J 38(6b): 

468–476. 

MM6 Spencer, A., Roberts, A., Kennedy, N., Ravera, C., Cremers, S., Bilic, S., Neeman, T., Copeman, M., Schran, H. and 

Lynch, K. (2008) Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic 

and safety sub-study. BMC Clin Pharmacol 8: 2. 

SC01 Thursky, K. A., Playford, E. G., Seymour, J. F., Sorrell, T. C., Ellis, D. H., Guy, S. D., Gilroy, N., Chu, J. and Shaw, D. R. 

(2008) Recommendations for the treatment of established fungal infections. Intern Med J 38(6b): 496–520. 

PT1 Wilkins, B. S., Erber, W. N., Bareford, D., Buck, G., Wheatley, K., East, C. L., Paul, B., Harrison, C. N., Green, A. R. 

and Campbell, P. J. (2008) Bone marrow pathology in essential thrombocythemia: interobserver reliability and 

utility for identifying disease subtypes. Blood 111(1): 60–70. 

SC01 Worth, L. J., Blyth, C. C., Booth, D. L., Kong, D. C., Marriott, D., Cassumbhoy, M., Ray, J., Slavin, M. A. and Wilkes, J. 

R. (2008) Optimizing antifungal drug dosing and monitoring to avoid toxicity and improve outcomes in patients 

with haematological disorders. Intern Med J 38(6b): 521–537. 

0 

50 

8 

34 

0 

21 

5 

4 

0 

0 

0 

43 

0 

2007 

CML5 

APML4 

LY02 

LS07 

AMLM11 

Branford, S., Hughes, T., Milner, A., Koelmeyer, R., Schwarer, A., Arthur, C., Filshie, R., Moreton, S., Lynch, K. and 

Taylor, K. (2007) Efficacy and safety of imatinib in patients with chronic myeloid leukemia and complete or 

near-complete cytogenetic response to interferon-alpha. Cancer 110(4): 801–808. 

Catalano, A., Dawson, M. A., Somana, K., Opat, S., Schwarer, A., Campbell, L. J. and Iland, H. (2007) The 

PRKAR1A gene is fused to RARA in a new variant acute promyelocytic leukemia. Blood 110(12): 4073–4076. 

Christie, D. R., Gabriel, G. S. and Dear, K. (2007) Adverse effects of a multicentre system for ethics approval 

on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting? Intern 

Med J 37(10): 680–686. 

Gandhi, M. K., Moll, G., Smith, C., Dua, U., Lambley, E., Ramuz, O., Gill, D., Marlton, P., Seymour, J. F. and Khanna, 

R. (2007) Galectin-1 mediated suppression of Epstein-Barr virus specific T-cell immunity in classic Hodgkin 

lymphoma. Blood 110(4): 1326–1329. 

Grigg, A. P., Gibson, J., Bardy, P. G., Reynolds, J., Shuttleworth, P., Koelmeyer, R. L., Szer, J., Roberts, A. W., To, 

L. B., Kennedy, G. and Bradstock, K. F. (2007) A prospective multicenter trial of peripheral blood stem cell 

sibling allografts for acute myeloid leukemia in first complete remission using fludarabine-cyclophosphamide 

reduced intensity conditioning. Biol Blood Marrow Transplant 13(5): 560–567. 

3 

20 

10 

34 

125



2007 

AMLM10 

ALL2 

ALL2 

Manoharan, A., Reynolds, J., Matthews, J., Baxter, H., Di Iulio, J., Leahy, M. and Juneja, S. (2007) Flexible lowintensity 

combination chemotherapy for elderly patients with acute myeloid leukaemia: a multicentre, phase II 

study. Drugs Aging 24(6): 481–488. 

Tavernier, E., Boiron, J. M., Huguet, F., Bradstock, K., Vey, N., Kovacsovics, T., Delannoy, A., Fegueux, N., Fenaux, 

P., Stamatoullas, A., Tournilhac, O., Buzyn, A., Reman, O., Charrin, C., Boucheix, C., Gabert, J., Lheritier, V., 

Vernant, J. P., Dombret, H. and Thomas, X. (2007) Outcome of treatment after first relapse in adults with acute 

lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia 21(9): 1907–1914. 

Tavernier, E., Le, Q. H., de Botton, S., Dhedin, N., Bulabois, C. E., Reman, O., Vey, N., Lheritier, V., Dombret, H. and 

Thomas, X. (2007) Secondary or concomitant neoplasms among adults diagnosed with acute lymphoblastic 

leukemia and treated according to the LALA-87 and LALA-94 trials. Cancer 110(12): 2747–2755. 

CML6 White, D. L., Saunders, V. A., Dang, P., Engler, J., Venables, A., Zrim, S., Zannettino, A., Lynch, K., Manley, P. W. 

and Hughes, T. (2007) Most CML patients who have a suboptimal response to imatinib have low OCT-1 activity: 

higher doses of imatinib may overcome the negative impact of low OCT-1 activity. Blood 110(12): 4064–4072. 

CML6 White, D., Saunders, V., Grigg, A., Arthur, C., Filshie, R., Leahy, M. F., Lynch, K., To, L. B. and Hughes, T. (2007) 

Measurement of in vivo BCR-ABL kinase inhibition to monitor imatinib-induced target blockade and predict 

response in chronic myeloid leukemia. J Clin Oncol 25(28): 4445–4451. 

11 

0 

24 

7 

104 

2006 

NHL_X3 

PT1 

PT1 

ALL2 

LS09 

BM02 

SC01 

NHL10 

CML6 

HD5 

NHLLOW4 

Campbell, J., Seymour, J. F., Matthews, J., Wolf, M., Stone, J. and Juneja, S. (2006) The prognostic impact of 

bone marrow involvement in patients with diffuse large cell lymphoma varies according to the degree of 

infiltration and presence of discordant marrow involvement. Eur J Haematol 76(6): 473–480. 

Campbell, P. J., Baxter, E. J., Beer, P. A., Scott, L. M., Bench, A. J., Huntly, B. J., Erber, W. N., Kusec, R., Larsen, 

T. S., Giraudier, S., Le Bousse-Kerdiles, M. C., Griesshammer, M., Reilly, J. T., Cheung, B. Y., Harrison, C. N. and 

Green, A. R. (2006) Mutation of JAK2 in the myeloproliferative disorders: timing, clonality studies, cytogenetic 

associations, and role in leukemic transformation. Blood 108(10): 3548–3555. 

Campbell, P. J., Griesshammer, M., Dohner, K., Dohner, H., Kusec, R., Hasselbalch, H. C., Larsen, T. S., Pallisgaard, 

N., Giraudier, S., Le Bousse-Kerdiles, M. C., Desterke, C., Guerton, B., Dupriez, B., Bordessoule, D., Fenaux, P., 

Kiladjian, J. J., Viallard, J. F., Briere, J., Harrison, C. N., Green, A. R. and Reilly, J. T. (2006) V617F mutation in 

JAK2 is associated with poorer survival in idiopathic myelofibrosis. Blood 107(5): 2098–2100. 

Dhedin, N., Dombret, H., Thomas, X., Lheritier, V., Boiron, J. M., Rigal-Huguet, F., Vey, N., Kuentz, M., Reman, O., 

Witz, F., Delannoy, A., Kovacsovics, T., Bradstock, K., Charrin, C., Boucheix, C., Gabert, J., Blaise, D., Fiere, D. and 

Vernant, J. P. (2006) Autologous stem cell transplantation in adults with acute lymphoblastic leukemia in first 

complete remission: analysis of the LALA-85, -87 and -94 trials. Leukemia 20(2): 336–344. 

Gandhi, M. K., Lambley, E., Burrows, J., Dua, U., Elliott, S., Shaw, P. J., Prince, H. M., Wolf, M., Clarke, K., Underhill, 

C., Mills, T., Mollee, P., Gill, D., Marlton, P., Seymour, J. F. and Khanna, R. (2006) Plasma Epstein-Barr virus (EBV) 

DNA is a biomarker for EBV-positive Hodgkin's lymphoma. Clin Cancer Res 12(2): 460–464. 

Grigg, A. P., Shuttleworth, P., Reynolds, J., Schwarer, A. P., Szer, J., Bradstock, K., Hui, C., Herrmann, R. and 

Ebeling, P. R. (2006) Pamidronate reduces bone loss after allogeneic stem cell transplantation. J Clin 

Endocrinol Metab 91(10): 3835–3843. 

Morrissey, C. O. and Slavin, M. A. (2006) Antifungal strategies for managing invasive aspergillosis: The 

prospects for a pre-emptive treatment strategy. Medical Mycology 44(suppl.): S333–348. 

Pfreundschuh, M., Trumper, L., Osterborg, A., Pettengell, R., Trneny, M., Imrie, K., Ma, D., Gill, D., Walewski, 

J., Zinzani, P. L., Stahel, R., Kvaloy, S., Shpilberg, O., Jaeger, U., Hansen, M., Lehtinen, T., Lopez-Guillermo, A., 

Corrado, C., Scheliga, A., Milpied, N., Mendila, M., Rashford, M., Kuhnt, E. and Loeffler, M. (2006) CHOP-like 

chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis 

diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. 

Lancet Oncol 7(5): 379–391. 

Ross, D. M., Branford, S., Moore, S. and Hughes, T. P. (2006) Limited clinical value of regular bone marrow 

cytogenetic analysis in imatinib-treated chronic phase CML patients monitored by RQ-PCR for BCR-ABL. 

Leukemia 20(4): 664–670. 

Smith, C., Cooper, L., Burgess, M., Rist, M., Webb, N., Lambley, E., Tellam, J., Marlton, P., Seymour, J. F., Gandhi, 

M. and Khanna, R. (2006) Functional reversion of antigen-specific CD8+ T cells from patients with Hodgkin 

lymphoma following in vitro stimulation with recombinant polyepitope. J Immunol 177(7): 4897–4906. 

van Oers, M. H., Klasa, R., Marcus, R. E., Wolf, M., Kimby, E., Gascoyne, R. D., Jack, A., Van't Veer, M., Vranovsky, 

A., Holte, H., van Glabbeke, M., Teodorovic, I., Rozewicz, C. and Hagenbeek, A. (2006) Rituximab maintenance 

improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with 

and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood 

108(10): 3295–3301. 

21 

115 

91 

16 

32 

15 

4 

485 

20 

15 

250 

Publications 

126



2005 

PT1 

HDNHL3 

AMLM7 

Baxter, E. J., Scott, L. M., Campbell, P. J., East, C., Fourouclas, N., Swanton, S., Vassiliou, G. S., Bench, A. J., Boyd, 

E. M., Curtin, N., Scott, M. A., Erber, W. N. and Green, A. R. (2005) Acquired mutation of the tyrosine kinase JAK2 

in human myeloproliferative disorders. Lancet 365(9464): 1054–1061. 

Biagi, J. J., Herbert, K. E., Smith, C., Abdi, E., Leahy, M., Falkson, C., Wolf, M., Januszewicz, H., Seymour, J. F., 

Richards, K., Matthews, J. P., Dale, B. and Prince, H. M. (2005) A phase II study of dexamethasone, ifosfamide, 

cisplatin and etoposide (DICE) as salvage chemotherapy for patients with relapsed and refractory lymphoma. 

Leuk Lymphoma 46(2): 197–206. 

Bradstock, K. F., Matthews, J. P., Lowenthal, R. M., Baxter, H., Catalano, J., Brighton, T., Gill, D., Eliadis, P., Joshua, 

D., Cannell, P., Schwarer, A. P., Durrant, S., Gillett, A., Koutts, J., Taylor, K., Bashford, J., Arthur, C., Enno, A., 

Dunlop, L., Szer, J., Leahy, M., Juneja, S. and Young, G. A. (2005) A randomized trial of high-versus conventionaldose 

cytarabine in consolidation chemotherapy for adult de novo acute myeloid leukemia in first remission 

after induction therapy containing high-dose cytarabine. Blood 105(2): 481–488. 

PT1 Campbell, P. J., Scott, L. M., Buck, G., Wheatley, K., East, C. L., Marsden, J. T., Duffy, A., Boyd, E. M., Bench, A. 

J., Scott, M. A., Vassiliou, G. S., Milligan, D. W., Smith, S. R., Erber, W. N., Bareford, D., Wilkins, B. S., Reilly, J. T., 

Harrison, C. N. and Green, A. R. (2005) Definition of subtypes of essential thrombocythaemia and relation to 

polycythaemia vera based on JAK2 V617F mutation status: a prospective study. Lancet 366(9501): 1945–1953. 

AMLM8 Grigg, A. P., Reynolds, J., McQuillan, A., Juneja, S. K., Di Iulio, J., Hui, C., Smith, C., Kimber, R. and Bradstock, K. F. 

(2005) Prognostic features for response and survival in elderly patients with de novo acute myeloid leukemia 

treated with mitoxantrone and intermediate dose cytarabine. Leuk Lymphoma 46(3): 367–375. 

PT1 Harrison, C. N., Campbell, P. J., Buck, G., Wheatley, K., East, C. L., Bareford, D., Wilkins, B. S., van der Walt, J. 

D., Reilly, J. T., Grigg, A. P., Revell, P., Woodcock, B. E. and Green, A. R. (2005) Hydroxyurea compared with 

anagrelide in high-risk essential thrombocythemia. N Engl J Med 353(1): 33–45. 

LY03 Johnson, S. A., Owen, R. G., Oscier, D. G., Leblond, V., Levy, V., Jaeger, U. and Seymour, J. F. (2005) Phase III 

study of chlorambucil versus fludarabine as initial therapy for Waldenstrom's macroglobulinemia and related 

disorders. Clin Lymphoma 5(4): 294–297. 

MM5 Spencer, A., Horvath, N., Gibson, J., Prince, H. M., Herrmann, R., Bashford, J., Joske, D., Grigg, A., McKendrick, 

J., Prosser, I., Lowenthal, R., Deveridge, S. and Taylor, K. (2005) Prospective randomised trial of amifostine 

cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell 

transplantation. Bone Marrow Transplant 35(10): 971–977. 

CML6 White, D., Saunders, V., Lyons, A. B., Branford, S., Grigg, A., To, L. B. and Hughes, T. (2005) In vitro sensitivity to 

imatinib-induced inhibition of ABL kinase activity is predictive of molecular response in patients with de novo 

CML. Blood 106(7): 2520–2526. 

HDNHL1 Wirth, A., Prince, H. M., Wolf, M., Stone, J. M., Matthews, J., Gibson, J., Macleod, C., Szer, J., Grigg, A., To, B., Roos, 

D., Schwarer, A. P. and Davis, S. (2005) Optimal scheduling to reduce morbidity of involved field radiotherapy 

with transplantation for lymphomas: a prospective Australasian Leukaemia and Lymphoma Group Study. 

Bone Marrow Transplant 35(3): 291–298. 

2003 

NHL_X3 Campbell, J. K., Matthews, J. P., Seymour, J. F., Wolf, M. M. and Juneja, S. K. (2003) Optimum trephine length in 

the assessment of bone marrow involvement in patients with diffuse large cell lymphoma. Ann Oncol 14(2): 

273–276. 

HD2 Federico, M., Bellei, M., Brice, P., Brugiatelli, M., Nagler, A., Gisselbrecht, C., Moretti, L., Colombat, P., Luminari, S., 

Fabbiano, F., Di Renzo, N., Goldstone, A. and Carella, A. M. (2003) High-dose therapy and autologous stem-cell 

transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to 

front-line therapy. J Clin Oncol 21(12): 2320–2325. 

2002 

APML3 Applegate, T. L., Iland, H. J., Mokany, E. and Todd, A. V. (2002) Diagnosis and molecular monitoring of acute 

promyelocytic leukemia using DzyNA reverse transcription-PCR to quantify PML/RARalpha fusion transcripts. 

Clin Chem 48(8): 1338–1343. 

APML3 Applegate, T. L., Iland, H. J., Mokany, E. and Todd, A. V. (2002) Molecular Monitoring of Acute Promyelocytic 

Leukemia by DzyNA Reverse Transcription-PCR. Clin Chem 48(10): 1858–1860. 

ALL2 Dombret, H., Gabert, J., Boiron, J. M., Rigal-Huguet, F., Blaise, D., Thomas, X., Delannoy, A., Buzyn, A., Bilhou- 

Nabera, C., Cayuela, J. M., Fenaux, P., Bourhis, J. H., Fegueux, N., Charrin, C., Boucheix, C., Lheritier, V., 

Esperou, H., MacIntyre, E., Vernant, J. P. and Fiere, D. (2002) Outcome of treatment in adults with Philadelphia 

chromosome-positive acute lymphoblastic leukemia—results of the prospective multicenter LALA-94 trial. 

Blood 100(7): 2357–2366. 

LY01 Mead, G. M., Sydes, M. R., Walewski, J., Grigg, A., Hatton, C. S., Pescosta, N., Guarnaccia, C., Lewis, M. S., 

McKendrick, J., Stenning, S. P. and Wright, D. (2002) An international evaluation of CODOX-M and CODOX-M 

alternating with IVAC in adult Burkitt's lymphoma: results of United Kingdom Lymphoma Group LY06 study. 

Ann Oncol 13(8): 1264–1274. 

1095 

8 

27 

290 

0 

235 

10 

28 

47 

5 

16 

40 

3 

1 

134 

76 

127

AlLg Publications 


2001 

AMLM7 

AMLM2, 

AMLM4 

NHLLOW5 

MM_X2 

Bradstock, K., Matthews, J., Young, G., Lowenthal, R., Baxter, H., Arthur, C., Bashford, J., Brighton, T., Cannell, P., 

Dunlop, L., Durrant, S., Enno, A., Eliadis, P., Gill, D., Gillett, A., Gottlieb, D., Januszewicz, H., Joshua, D., Leahy, M., 

Schwarer, A. and Taylor, K. (2001) Effects of glycosylated recombinant human granulocyte colony-stimulating 

factor after high-dose cytarabine-based induction chemotherapy for adult acute myeloid leukaemia. Leukemia 

15(9): 1331–1338. 

Matthews, J. P., Bishop, J. F., Young, G. A., Juneja, S. K., Lowenthal, R. M., Garson, O. M., Cobcroft, R. G., Dodds, A. 

J., Enno, A., Gillett, E. A., Herrmann, R. P., Joshua, D. E., Ma, D. D., Szer, J., Taylor, K. M., Wolf, M. and Bradstock, 

K. F. (2001) Patterns of failure with increasing intensification of induction chemotherapy for acute myeloid 

leukaemia. Br J Haematol 113(3): 727–736. 

McManus, M. P. and Seymour, J. F. (2001) Management of localised low-grade follicular lymphomas. 

Austral Radiol. 

The Myeloma Trialists' Collaborative Group (2001) Interferon as therapy for multiple myeloma: an individual 

patient data overview of 24 randomized trials and 4012 patients. Br J Haematol 113(4): 1020–1034. 

21 

10 

– 

108 

Publications 

128

ALSG Publications 


1999 

AMLM6 

1998 

AMLM2, 

AMLM4 

Lowenthal, R. M., Bradstock, K. F., Matthews, J. P., Bishop, J. F., Juneja, S., Cobcroft, R., Eliadis, P., Enno, A., Gill, 

D., Herrmann, R. P., Manoharan, A., Page, F. J., Rooney, K. F., Rosenfeld, D., Seldon, M., Taylor, K. M., Wolf, M. 

M. and Young, G. A. (1999) A phase I/II study of intensive dose escalation of cytarabine in combination with 

idarubicin and etoposide in induction and consolidation treatment of adult acute myeloid leukemia. Australian 

Leukaemia Study Group (ALSG). Leuk Lymphoma 34(5-6): 501–510. 

Bishop, J. F., Matthews, J. P., Young, G. A., Bradstock, K. and Lowenthal, R. M. (1998) Intensified induction 

chemotherapy with high dose cytarabine and etoposide for acute myeloid leukemia: a review and updated 

results of the Australian Leukemia Study Group. Leuk Lymphoma 28(3-4): 315–327. 

1997 

MM2 Joshua, D. E., Penny, R., Matthews, J. P., Laidlaw, C. R., Gibson, J., Bradstock, K., Wolf, M. and Goldstein, D. (1997) 

Australian Leukaemia Study Group myeloma II: a randomized trial of intensive combination chemotherapy 

with or without interferon in patients with myeloma. Br J Haematol 97(1): 38–45. 

1996 

AMLM2, 

AMLM4 

AMLM4 

1995 

APML1 

1994 

AMLM4 

AMLM4 

AMLM4 

MM1 

AMLM6 

Bishop, J., Young, G. A. R., Matthews, J. P. and Bradstock, K. F. (1996) Response: Induction endpoints in AML. 

Blood 88(2): 754–755. 

Bishop, J. F., Matthews, J. P., Young, G. A., Szer, J., Gillett, A., Joshua, D., Bradstock, K., Enno, A., Wolf, M. M., 

Fox, R., Cobcroft, R., Herrmann, R., Van Der Weyden, M., Lowenthal, R. M., Page, F., Garson, O. M. and Juneja, 

S. (1996) A randomized study of high-dose cytarabine in induction in acute myeloid leukemia. Blood 87(5): 

1710–1717. 266 

Wiley, J. S. and Firkin, F. C. (1995) Reduction of pulmonary toxicity by prednisolone prophylaxis during all-trans 

retinoic acid treatment of acute promyelocytic leukemia. Australian Leukaemia Study Group. Leukemia 9(5): 

774–778. 

Bishop, J. F., Matthews, J. P., Young, G., Szer, J., Joshua, D. E., Dodds, A., Laidlaw, C. R., Cobcroft, R., Herrman, R., 

Ma, D. and et al. (1994) The influence of induction chemotherapy dose and dose intensity on the duration of 

remission in acute myeloid leukemia. Australian Leukemia Study Group. Leuk Lymphoma 15(1-2): 79–84. 

Bradstock, K., Matthews, J., Benson, E., Page, F. and Bishop, J. (1994) Prognostic value of immunophenotyping 

in acute myeloid leukemia. Australian Leukaemia Study Group. Blood 84(4): 1220–1225. 

Coghlan, D. W., Morley, A. A., Matthews, J. P. and Bishop, J. F. (1994) The incidence and prognostic significance 

of mutations in codon 13 of the N-ras gene in acute myeloid leukemia. Leukemia 8(10): 1682–1687. 

Joshua, D., Wolf, M., Matthews, J., Tan, L., Sheridan, W., Pilkington, G. and Page, F. (1994) Peripheral blood 

lymphocyte surface antigen expression and prognosis in myeloma: Australian Leukaemia Study Group Study. 

Leuk Lymphoma 14(3-4): 303–309. 

Lowenthal, R. (1994) A new effective drug for treatment of adult acute myeloid leukaemia. Aust J Hosp Pharm 

24: 159–164. 

1992 

AMLM2 Bishop, J. (1992) Etoposide in the management of acute leukaemia. Semin Oncol 19(6): 1–6. – 

1991 

AMLM2 Bishop, J., Lowenthal, R. and Joshua, D. (1991) Etoposide in leukaemia. The Yearbook of Hematology. J. L. 

– 

Spivak and W. R. Bell, Mosby-Year Book. 

AMLM2 Bishop, J. F. (1991) Etoposide in the management of leukemia: a review. Semin Oncol 18(1 (Suppl 2)): 62–69. 9 

– Bishop, J. F., Lowenthal, R., Joshua, D., Matthews, J. P., Wolf, M. M. and Cooper, I. A. (1991) Etoposide in 

leukemia. Cancer 67(1 Suppl): 285–291. 

– Lowenthal, R. M. and Lambertenghi-Deliliers, G. (1991) Oral idarubicin as treatment for advanced 

myelodysplastic syndrome. Haematologica 76(5): 398–401. 

1990 

AMLM2 

AMLM2 

Bishop, J. F., Lowenthal, R. and Joshua, D. (1990) Etoposide in acute non-lymphocytic leukaemia. Haematology 

Digest 5: 13–14. 

Bishop, J. F., Lowenthal, R. M., Joshua, D., Matthews, J. P., Todd, D., Cobcroft, R., Whiteside, M. G., Kronenberg, 

H., Ma, D., Dodds, A. and et al. (1990) Etoposide in acute nonlymphocytic leukemia. Australian Leukemia Study 

Group. Blood 75(1): 27–32. 

23 

6 

32 

1 

266 

57 

57 

9 

86 

36 

4 

6 

10 

– 

189 

129

Alsg Publications 


1989 

AMLM2 

Bishop, J. F., Lowenthal, R. M., Joshua, D. and Wolf, M. (1989) Etoposide in acute myeloid leukaemia. Leukaemia 

Res 42: 332. 

AMLM2 Bishop, J., Lowenthal, R. and Joshua, D. (1989) Prospects for cure in acute leukaemia. J Clin Pathol 42(3): 332. 0 

1987 

– Lowenthal, R. M., Chesterman, C. N., Griffiths, J. D., Manoharan, A., Harris, M. G., Herrmann, R. P., Rooney, K. F., 

Rozenberg, M. C., Salem, H. H., Wolf, M. M. and et al. (1987) Oral idarubicin as single-agent treatment of acute 

nonlymphocytic leukemia in poor-risk patients. Cancer Treat Rep 71(12): 1279–1281. 

1986 

AMLM2 Bishop, J. F., Joshua, D. E., Lowenthal, R. M., Kronenberg, H., Whiteside, M. G., Cobcroft, R., Dodds, A., Wolf, M. 

and Manoharan, A. (1986) A phase I-II study of cytosine arabinoside, daunorubicin, and VP16-213 in adult 

patients with acute non-lymphocytic leukemia. Aust N Z J Med 16(1): 48–51. 

– 

26 

22 

Publications 

130

Anzlg Publications 


1997 

HD1 

NHL5 

1996 

NHLLOW2 

1994 

NHL5 

NHL5 

1992 

NHL4 

1987 

NHL1 

1986 

NHL2 

1982 

NHL1 

Connors, J. M., Klimo, P., Adams, G., Burns, B. F., Cooper, I., Meyer, R. M., O'Reilly, S. E., Pater, J., Quirt, I., Sadura, 

A., Shustik, C., Skillings, J., Sutcliffe, S., Verma, S., Yoshida, S. and Zee, B. (1997) Treatment of advanced 

Hodgkin's disease with chemotherapy--comparison of MOPP/ABV hybrid regimen with alternating courses of 

MOPP and ABVD: a report from the National Cancer Institute of Canada clinical trials group. J Clin Oncol 15(4): 

1638–1645. 

Wolf, M., Matthews, J. P., Stone, J., Cooper, I. A., Robertson, T. I. and Fox, R. M. (1997) Long-term survival 

advantage of MACOP-B over CHOP in intermediate-grade non-Hodgkin's lymphoma. The Australian and New 

Zealand Lymphoma Group. Ann Oncol 8 (Suppl 1): 71–75. 

Morton, J., Taylor, K., Bunce, I., Eliadis, P., Rentoul, A., Moore, D., Kelly, C., Wright, S., Bashford, J., Rodwell, R., 

Rooney, K., Mulligan, S., Firkin, F., Dodds, A., Parkin, J., Lowenthal, R., Kimber, R., Frost, T., Grigg, A., Goldstein, 

D., Stone, J. and Lee, N. (1996) High response rates with short infusional 2-chlorodeoxyadenosine in de novo 

and relapsed low-grade lymphoma. Australian and New Zealand Lymphoma Study Group. Br J Haematol 

95(1): 110–115. 

Cooper, I. A., Wolf, M. M., Robertson, T. I., Fox, R. M., Matthews, J. P., Stone, J. M., Ding, J. C., Dart, G., Matthews, J., 

Firkin, F. C. and et al. (1994) Randomized comparison of MACOP-B with CHOP in patients with intermediategrade 

non-Hodgkin's lymphoma. The Australian and New Zealand Lymphoma Group. J Clin Oncol 12(4): 

769–778. 

Stone, J. M., Page, F. J., Laidlaw, C. R. and Cooper, I. (1994) Selection of patients for randomized trials – a study 

based on the MACOP-B vs CHOP in NHL study. Aust N Z J Med 24(5): 536–540. 

Matthews, J. R., Cooper, I. A., Matthews, J. P. and Ding, J. C. (1992) Failure of intensive chemotherapy in poor 

prognosis non-Hodgkin's lymphoma. Aust N Z J Med 22(2): 123–128. 

Benson, W. J., Ding, J. C. and Cooper, I. A. (1987) Abdominal CT and lymphography in the initial staging of non- 

Hodgkin's lymphoma. Aust N Z J Med 17(2): 253–254. 

Ding, J. C., Cooper, I. A., Firkin, F., Matthews, J. P. and Robertson, T. I. (1986) Investigation of the additive 

potential of teniposide and vincristine in non-Hodgkin's lymphoma. Canc Treat Rep 70(8): 985–990. 

Cooper, I. A. (1982) A comparison of the use of teniposide and vincristine in combination chemotherapy for 

non-Hodgkin's lymphoma. Canc Treat Rep 66(1): 49–55. 

90 

21 

14 

86 

3 

3 

11 

2 

0 

131

Meeting presentations 

and abstracts 

ALLG meeting presentations and abstracts 

Trial Title 

2011 

NHL16 Bouteloup, M., Seymour, J., Feugier, P., Offner, F., Lopez-Guillermo, A., Bouabdallah, R., Pedersen, L. M., Brice, P., Belada, D. 

and Salles, G. (2011) Pattern of infections observed during the maintenance phase in the PRIMA study. Ann Oncol 22(suppl 

4): iv189. 11th International Conference on Malignant Lymphoma. abstract 318. 

NHL21 Gandhi, M. K., Hertzberg, M., Han, E., Seymour, J. F., Hicks, R., Gill, D., Keane, C., Crooks, P., Radford, K. and Vari, F. (2011) 

Monocytes are associated with impaired T-cell immunity and residual interim-PET/CT avidity after 4 cycles of CHOP-R 

in patients with high-risk DLBCL. Blood 118(21). 53rd Annual Meeting of the American Society of Hematology (ASH). 

abstract 3673. 

NHL21 Gandhi, M., Hertzberg, M., Han, E., Keane, C., Lopez, A., Radford, K., Seymour, J., Gill, D. and Vari, F. (2011) The kinetics of 

systemic cellular immunosuppression in patients with poor-risk diffuse large B-cell lymphoma during treatment with 

'CHOP-R': A prospective study from the ALLG. Haematologica 96(suppl. 2): 143. 16th Congress of the European Hematology 

Association. abstract 0345. 

NHL16 Ghesquieres, H., Seymour, J. F., Offner, F., Feugier, P., Brice, P., Haioun, C., Casasnovas, O., Catalano, J., Jardin, F., Xerri, L. and 

Salles, G. (2011) FC Y R3A polymorphism does not significantly affect response and outcome of follicular lymphoma patients 

treated in the PRIMA study with rituximab and chemotherapy followed by rituximab maintenance or observation. Ann Oncol 

22(suppl. 4): iv187-188. 11th International Conference on Malignant Lymphoma abstract 313. 

NHL13 Gisselbrecht, C., Glass, B., Fournier, M., Gill, D., Linch, D., Trneny, M., Bosly, A., Shpilberg, O., Hagberg, H., Ketterer, N., Ma, D., 

Gaulard, P. and Moskowitz, C. (2011) Salvage regimen with autologous stem cell transplantation with or without rituximab 

maintenance for relapsed diffuse large B-cell lymphoma (DLBCL): CORAL final report. Ann Oncol 22(suppl. 4): iv107. 11th 

International Conference on Malignant Lymphoma. abstract 075. 

NHL13 Gisselbrecht, C., Glass, B., Laurent, G., Gill, D. S., Linch, M. D., Trneny, M., Bron, D., Shpilberg, O., Hagberg, H., Bargetzi, M., Ma, 

D., Briere, J., Moskowitz, C. and Schmitz, N. (2011) Maintenance with rituximab after autologous stem cell transplantation in 

relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis. J Clin Oncol 29(15 suppl.). 2011 

Annual Meeting of the American Society of Clinical Oncology. abstract 8004. 

CML9 Goyne, J., Ross, D., Dang, P., Slader, C., Yeung, D., Mills, A., Grigg, A., Hughes, T. P. and White, D. L. (2011) BCR-ABL DNA PCR for 

the monitoring of CP-CML patients treated with imatinib: A TIDEL II sub-study. Haematology Society of Australia and New 

Zealand (HSANZ) Annual Scientific Meeting 2011. abstract P209. 

MDS3 Kenealy, M., Giri, P., Filshie, R., Ho, S.-J., Nicol, A., Cowan, L., Link, E. and Seymour, J. F. (2011) Results of a phase II study of 

thalidomide (Thal) and azacitidine (Aza) in patients with clinically advanced myelodysplastic syndromes (MDS) Leuk Res 35 

(suppl. 1): S22. 11th International Symposium on Myelodysplastic Syndromes (MDS). abstract 60. 

MDS3 Kenealy, M., Wong, N., Maksimovic, J., Filshie, R. and Seymour, J. F. (2011) Do genome scale methylation changes in patients 

with MDS treated with azacitidine and thalidomide correlate with response to treatment? Leuk Res 35(suppl. 1): S69. 11th 

International Symposium on Myelodysplastic Syndromes (MDS) abstract 176. 

LY03 Leblond, V., Lejeune, J., Tournilhac, O., Morel, P., Dihuydy, M. S., Dartigeas, C., Malphette, M., Royer, B., Seymour, J. F., Chevret, 

S., Johnson, S. and Owen, R. G. (2011) International phase III study of chlorambucil versus fludarabine as initial therapy for 

Waldenström’s macroglobulinemia and related disorders: Results of 414 patients on behalf of FCG CLL/WM, GOELAMS, 

GELA, NCRI, ALLG. Blood 118(21). 53rd Annual Meeting of the American Society of Hematology (ASH). abstract 776. 

LY03 Leblond, V., Lejeune, J., Tournilhac, O., Morel, P., Dihuydy, M., Dartigeas, C., Malphette, M., Royer, B., Chevret, S., Johnson, S. 

and Owen, R. (2011) International Phase III study of chlorambucil versus fludarabine as initial therapy for Waldenstrom's 

macroglobulinemia and related disorders: Results in 414 patients on behalf of FCGCLL/WM, GOELAMS, GELA and NCRI. Ann 

Oncol 22(suppl. 4): iv128. 11th International Conference on Malignant Lymphoma. abstract 134. 

NHL14 Lowry, L., Pule, M., Ardeshna, K., Qian, W., Smith, P., Pocock, C., Miall, F., Cunningham, D., Davies, J., Bradstock, K. and Linch, 

D. C. (2011) FCgR polymorphisms do not influence response to rituximab in a symptomatic, non-bulky follicular lymphoma; 

Results from intergroup trial of rituximab vs "watch and wait". Ann Oncol 22(suppl. 4): iv131. 11th International Conference 

on Malignant Lymphoma. abstract 142. 

MM8 Mollee, P., Tiley, C., Cunningham, I., Moore, J., Prince, M., Cannell, P., Gibbons, S., Tate, J., Paul, S. and Gill, D. (2011) A phase 

II study of risk-adapted intravenous melphalan in patients with AL amyloidosis. Haematologica 96(suppl. 1): S155. 13th 

International Myeloma Workshop. abstract P427. 

MM8 Mollee, P., Tiley, C., Cunningham, I., Moore, J., Prince, M., Cannell, P., Gibbons, S., Tate, J., Paul, S. and Gill, D. S. (2011) A phase 

II study of risk-adapted intravenous melphalan in patients with AL amyloidosis. Blood 118(21). 53rd Annual Meeting of the 

American Society of Hematology (ASH). abstract 3973. 

Meetings, Presentations 

and Abstracts 

132

ALLG Meeting presentations and abstracts 

Trial 

2011 

NHL16 

CLL5 

NHL19 

LY05 

Title 

Morschhauser, F., Seymour, J., Feugier, P., Offner, F., Lopez-Guillermo, A., Bouabdallah, R., Pedersen, L., Brice, P., Belada, D., 

Xerri, L. and Salles, G. (2011) Impact of induction chemotherapy regimen on response, safety and outcome in the PRIMA 

study. Ann Oncol 22(suppl. 4): iv89. 11th International Conference on Malignant Lymphoma. abstract 022. 

Mulligan, S. P., Gill, D., Turner, P., Renwick, W., Harrup, R., Latimer, M., Berkahn, L., Simpson, D., Sulda, M., Best, G., Kuss, 

B. and Cull, D. (2011) Safety and tolerability of oral fludarabine, with or without oral cyclophosphamide and intravenous 

rituximab rherapy, in previously untreated patients with chronic lymphocytic leukaemia aged 65 years or older: second 

interim analysis from the Australasian Leukaemia and Lymphoma Group and CLL Australian Research Consortium CLL5 

study Clinical Lymphoma, Myeloma and Leukemia 11(suppl. 2): S259-S260. 14th International Workshop on Chronic 

Lymphocytic Leukemia. abstract 5.25. 

Pfreundschuh, M., Kuhnt, E., Truemper, L., Osterborg, A., Trneny, M., Shepherd, L., Gill, D., Walewski, J., Pettengell, R., Jaeger, 

U., Zinzani, P. L., Shpilberg, O., Grass, S., Murawski, N., Poeschel, V. and Loeffler, M. (2011) 6-year follow-up of the MINT study 

suggests a role for radiotherapy to bulky disease. Ann Oncol 22(suppl. 4): iv91. 11th International Conference on Malignant 

Lymphoma. abstract 029. 

Rule, S., Smith, P., Johnson, P. W., Bolam, S., Follows, G. A., Gambell, J., Hillmen, P., Jack, A., Johnson, S. A. N., Kirkwood, 

A., Kruger, A., Seymour, J. F., Toncheva, M., Walewski, J. and Linch, D. C. (2011) The addition of rituximab to fludarabine 

and cyclophosphamide (FC) improves overall survival in newly diagnosed mantle cell lymphoma (MCL): Results of the 

randomised UK National Cancer Research Institute (NCRI). Blood 118(21). 53rd Annual Meeting of the American Society of 

Hematology (ASH). abstract 440. 

– Stone, J. M. (2011) Lost in space? Long term follow-ups, survivorship and archiving. 20th Australian Health and Research 

Data Managers Association (AHRDMA) Annual Scientific Meeting. 

NHL16 Tychyj-Pinel, C., Ricard, F., Meignan, M., Lamy, T., Estell, J., Shpilberg, O., Gyan, E., Decaudin, D., Tilly, H., Forsyth, C., Garin, E., 

Fulham, M., Salles, G. and Trotman, J. (2011) PET-CT of follicular lymphoma in patients treated in the PRIMA study: Central 

review of scans using the 5PS. Ann Oncol 22(suppl. 4). 11th International Conference on Malignant Lymphoma. abstract 046. 

CML9 Wang, J., Hughes, T. P., Kok, C. H., D’Andrea, R. J. and White, D. L. (2011) PPARγ ligands modulate OCT-1 activity in BCR-ABL+ 

cell lines and primary CML cells. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 

2011. abstract O146. 

CML9 Wang, J., Hughes, T. P., Kok, C. H., Saunders, V. A., Frede, A., Groot Obbink, K., Osborn, M. P., Somogyi, A. A., D'Andrea, R. J. and 

White, D. L. (2011) Non-steroidal anti-inflammatory drugs and imatinib; drug interactions that may impact efficacy. Blood 

118(21). 53rd Annual Meeting of the American Society of Hematology (ASH). abstract 3501. 

CML9 Watkins, D., Kok, C., Hughes, T., D’Andrea, R. and White, D. (2011) Development of a predictive classifier for poor risk chronicphase 

CML patients at diagnosis using immunophenotyping. Haematology Society of Australia and New Zealand (HSANZ) 

Annual Scientific Meeting 2011. abstract O143. 

CML9 Watkins, D. B., Kok, C. H., Hughes, T. P., Slader, C., D'Andrea, R. and White, D. L. (2011) Differential lineage involvement 

between very low and higher OCT-1 activity chronic-phase CML patients. Blood 118(21). 53rd Annual Meeting of the 


CML9 White, D. L., Saunders, V. A., Frede, A., Groot Obbink, K., Slader, C., Yeung, D. T., Osborn, M., Mills, A. K., Grigg, A. and Hughes, 

T. P. (2011) The strategy of early nilotinib switch based on failure to achieve optimal molecular targets on imatinib may not 

overcome the negative impact of a low OCT-1 activity in de-novo CP-CML patients. Blood 118(21). 53rd Annual Meeting of 

the American Society of Hematology (ASH). abstract 1690. 

CML9 White, D. L., Saunders, V. A., Frede, A. K., Groot Obbink, K., Slader, C., Yeung, D., Osborn, M., Mills, A., Grigg, A. and Hughes, T. 

P. (2011) The TIDEL II strategy of imatinib dose intensification and nilotinib switch may not overcome the negative impact 

of a low OCT-1 activity in de-novo CP-CML patients. Haematology Society of Australia and New Zealand (HSANZ) Annual 

Scientific Meeting 2011. abstract O145. 

CML9 Yeung, D., Osborn, M., White, D., Branford, S., Kornhauser, M., Slader, C., Hiwase, D., Hertzberg, M., Schwarer, A., Filshie, D., 

Arthur, C., Kwan, Y., Forsyth, C., Ross, D., Mills, A., Grigg, P. and Hughes, T. (2011) CML patients failing to achieve MMR by 12 

months may benefit from dose escalation or switching to nilotinib: A 24 month update of results from the TIDEL-II trial. 

Hematologica 96(suppl. 2): 55. 16th Congress of the European Haematology Association. abstract 0137. 

CML9 Yeung, D. T., Osborn, M., White, D. L., Branford, S., Kornhauser, M., Slader, C., Issa, S., Hiwase, D. K., Hertzberg, M. S., Schwarer, 

A. P., Filshie, R., Arthur, C. K., Kwan, Y. L., Forsyth, C. J., Ross, D., Mills, A. K., Grigg, A. and Hughes, T. P. (2011) Upfront imatinib 

therapy in CML patients with rapid switching to nilotinib for failure to achieve molecular targets or intolerance achieves 

high overall rates of molecular response and a low risk of progression - an update of the TIDEL-II trial. Blood 118(21). 53rd 

Annual Meeting of the American Society of Hematology (ASH). abstract 451. 

NHL16 Zhou, X., Wang, J., Zhang, J., Copley-Merriman, K., Torigoe, Y., Reyes, C., Seymour, J. F., Lopez-Guillermo, A., Offner, F., Trneny, 

M. and Salles, G. A. (2011) Symptoms and toxicity of rituximab maintenance (R-M) versus observation (OBS) following 

rituximab plus chemotherapy in patients with follicular lymphoma. Blood 118(21). 53rd Annual Meeting of the American 

Society of Hematology (ASH). abstract 3661. 

133

ALLG Meeting Presentations and Abstracts 

Trial 

2010 

MDS3 

APML4 

APML4 

HD9 

HD9 

MM8 

SC01 

SC01 

Title 

Gangatharen, S., Carney, D., Prince, M., Kenealy, M. and Seymour, J. (2010) Cytogenetic changes in myelodysplastic 

syndromes treated with Azacitidine: Illuminating mechanisms of action. Haematology Society of Australia and New Zealand 

(HSANZ) Annual Scientific Meeting 2010. abstract P082. 

Iland, H. J., Firkin, F., Supple, S., Catalano, J., Bashford, J., Filshie, R., Grigg, A., Hertzberg, M., Moore, J., Rowlings, P., Taylor, K., 

Tiley, C. and Seymour, J. F. (2010) Interim analysis of the APML4 trial incorporating all-trans retinoic acid (ATRA), idarubicin 

and intravenous arsenic trioxide (ATO) as initial therapy in acute promyelocytic leukaemia (APL): An Australasian Leukaemia 

and Lymphoma Group study. Hong Kong Society of Haematology. 

Iland, H. J., Firkin, F., Supple, S., Catalano, J., Bashford, J., Filshie, R., Grigg, A., Hertzberg, M., Moore, J., Rowlings, P., Taylor, K., 

Tiley, C. and Seymour, J. F. (2010) Interim analysis of the APML4 trial incorporating all-trans retinoic acid (ATRA), idarubicin 

and intravenous arsenic trioxide (ATO) as initial therapy in acute promyelocytic leukaemia (APL): An Australasian Leukaemia 

and Lymphoma Group study. The Second Asian Oncology Summit 2010. 

Koh, E., Wirth, A., Seymour, J., Barton, M. and Gabriel, G. (2010) Variability in long-term follow-up of Hodgkin survivors: 

an Australian and New Zealand patterns of care study (ALLG HD9). Haematology Society of Australia and New Zealand 

(HSANZ) Annual Scientific Meeting 2010. abstract O119. 

Koh, E., Wirth, A., Seymour, J., Barton, M. B. and Gabriel, G. S. (2010) Variability in long-term follow-up care for Hodgkin 

lymphoma (HL) survivors: An Australian and New Zealand (ANZ) patterns of care study (ALLG HD9). Asia-Pacific Journal of 

Clinical Oncology 6(suppl. 3): 139. COSA 37th Annual Scientific Meeting. abstract 159. 

Mollee, P., Tate, J., Weiss, D. and Solomon, A. (2010) Assessment of a monoclonal antibody-based free light chain ELISA and 

the polyclonal antibody-based Freelite assay in AL amyloidosis. Amyloid 17(suppl. 1): 199. XII International Symposium on 

Amyloidosis. abstract P-206. 

Morrissey, C. O. (2010) Biological markers of invasive aspergillosis and outcomes. 1st ASEAN Federation of Haematology 

Scientific Meeting. 

Morrissey, C. O. (2010) Molecular testing for Aspergillus: The ASPID Trial. 1st Biannual Clinical Mycology Meeting. 

CLL5 Mulligan, S. P., Gill, D. S., Renwick, W. E. P., Sulda, M. L., Best, O. G., Kuss, B. J. and Seymour, J. F. (2010) The safety and 

tolerability of oral fludarabine ± oral cyclophosphamide and iv rituximab therapy in previously untreated patients with 

chronic lymphocytic leukaemia (CLL) aged ≥65 years - interim analysis from the Australasian Leukaemia and Lymphoma 

Group (ALLG) and the CLL Australian Research Consortium (CLLARC) CLL5 study. Blood 116(21). 52nd Annual Meeting of the 


CLL5 Mulligan, S., Gill, D., Renwick, W. and Seymour, J. (2010) The safety and tolerability of oral fludarabine, oral 

cyclophosphamide and iv rituximab therapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) aged 

>65 years: an interim report from the Australasian Leukaemia and Lymphoma Group (ALLG) and CLL Australian Research 

Consortium (CLLARC) study. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2010. 

abstract O077. 

LY03 Owen, R. G., Johnson, S. A., Lejeune, J., Tournilhac, O., Morel, P., Ewings, M., Chevret, S. and Leblond, V. (2010) International 

Phase III study of chlorambucil versus fludarabine as initial therapy for Waldenstrom macroglobulinemia and related 

disorders: results in 414 patients. 6th International Workshop on Waldenstrom's Macroglobulinemia. 

NHL16 Salles, G. A., Catalano, J., Feugier, P., Offner, F. C., Bouabdallah, R., Caballero, D., Brice, P., Pedersen, L. M., Haioun, C., Belada, 

D., Delmer, A., Simpson, D., Tilly, H., Leppa, S., Hagenbeek, A., Casasnovas, O., Intragumtornchai, T., Fermé, C., Gomes Da 

Silva, M., Sebban, C., Lister, A., Estell, J., Milone, J., Sonnet, A., Lopez-Guillermo, A., Seymour, J. F. and Xerri, L. (2010) Updated 

results with 36 months follow-up of the PRIMA study confirms the benefit of 2-years rituximab maintenance in follicular 

lymphoma patients responding to immunochemotherapy. Blood 116(21). 52nd Annual Meeting of the American Society of 


NHL16 Salles, G. A., Seymour, J. F., Feugier, P., Offner, F., Lopez-Guillermo, A., Bouabdallah, R., Pedersen, L. M., Brice, P., Belada, D. 

and Xerri, L. (2010) Rituximab maintenance for 2 years in patients with untreated high tumor burden follicular lymphoma 

after response to immunochemotherapy. J Clin Oncol 28(15 (suppl.)). 2010 American Society of Clinical Oncology (ASCO) 

Annual Meeting. abstract 8004. 

NHL16 Salles, G., Catalano, J., Feugier, P., Offner, F., Bouabdallah, R., Caballero, D., Brice, P., Moller-Pedersen, L., Haioun, C., Belada, 

D., Delmer, A., Simpson, D., Tilly, H., Leppa, S., Soubeyran, P., Hagenbeek, A., Casasnovas, O., Tanin, I., Ferme, C., Gomes Da 

Silva, M., Sebban, C., Pettengell, R., Estell, J., Milone, G., Sonnet, A., López-Guillermo, A., Seymour, J. and Xerri, L. (2010) 

Rituximab maintenance for 2-years significantly improves the outcome of patients with untreated high tumor burden 

follicular lymphoma after response to immunochemotherapy. Results of the PRIMA study. Haematologica 95(suppl. 2): 229. 

15th Congress of the European Hematology Association. abstract 557. 

– Stone, J. and Lindenmayer, M. (2010) An interactive database to manage trials and processes for the Australasian 

Leukaemia and Lymphoma Group (ALLG). 19th Australian Health and Research Data Managers Association (AHRDMA) 

Annual Scientific Meeting. 

NHL16 Trotman, J., Fournier, M., Lamy, T., Estell, J., Sonet, A., Janikova, A., Tilly, H., Decaudin, D., Gabarre, J., Seymour, J. F., 

Forsyth, C., Garin, E., Fulham, M., Vander Borght, T., Shpilberg, O. and Salles, G. (2010) Result of PET-CT imaging after 

immunochemotherapy induction is a powerful and independent prognostic indicator of outcome for patients with follicular 

lymphoma: An analysis of the PRIMA Study. Blood 116(21). 52nd Annual Meeting of the American Society of Hematology 

(ASH). abstract 855. 

Meeting Presentations 

and Abstracts 

134


Trial 

2010 

AMLM7 

CML9 

CML9 

Title 

Wei, A., Ling, V., Bradstock, K. and Seymour, J. (2010) A clinical risk score identifies patients with AML and intermediate-risk 

karyotype but poor clinical outcome after HiDAC-based induction. Haematology Society of Australia and New Zealand (HSANZ) 

Annual Scientific Meeting 2010. abstract O079. 

White, D., Saunders, V., Frede, A., GrootObbink, K., Slader, C., Branford, S., Osborn, M., Yeung, D., Mills, A., Grigg, A. and Hughes, 

T. (2010) Imatinib intolerant CML patients respond better to nilotinib than imatinib refractory patients, and this may be due 

to underlying intrinsic factors: A TIDEL II sub study. Haematology Society of Australia and New Zealand (HSANZ) Annual 

Scientific Meeting 2010. abstract O032. 

White, D., Saunders, V., Menelaou, A., Rofe, A., Stader, C., Yeung, D., Osborn, M., Mills, A. and Grigg, A. (2010) Imatinib PK: 

Observations from the TIDEL II study. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific 

Meeting 2010. abstract O034. 

CML9 White, D. L., Saunders, V., Andrew, M., Rofe, A., Slader, C., Yeung, D. T., Osborn, M., Mills, A. K., Grigg, A. and Hughes, T. 

(2010) Imatinib PK: Observations from the TIDEL II study. Blood 116(21). 52nd Annual Meeting of the American Society of 


CML9 White, D. L., Saunders, V., Frede, A., GrootObbink, K., Slader, C., Yeung, D. T., Osborn, M., Mills, A. K., Grigg, A. and Hughes, T. 

(2010) Early switching from imatinib to nilotinib In CML patients failing to achieve early molecular targets may not be an 

effective approach in patients with very low OCT-1 activity: A TIDEL II sub-study. Blood 116(21). 52nd Annual Meeting of the 


CML9 Yeung, D., Osborn, M., White, D., Branford, S., Haswell, L., Slader, C., Hertzberg, M., Schwarer, A., Filshie, R., Arthur, C., Grigg, A. 

and Hughes, T. (2010) Selective escalation of Imatinib therapy and early switching to Nilotinib leads to superior outcomes in 

de novo CML patients: Interim results from cohort 1 of the TIDEL-II trial. Haematology Society of Australia and New Zealand 

(HSANZ) Annual Scientific Meeting 2010. abstract O031. 

CML9 Yeung, D. T., Osborn, M., White, D. L., Branford, S., Haswell, L., Slader, C., Issa, S., Hiwase, D. K., Hertzberg, M. S., Schwarer, 

A. P., Filshie, R., Arthur, C. K., Kwan, Y. L., Forsyth, C. J., Ross, D. M., Mills, A. K., Grigg, A. and Hughes, T. (2010) Selective 

escalation of imatinib therapy and early switching to nilotinib in de novo chronic phase CML patients: Interim results from 

the TIDEL-II trial. Blood 116(21). 52nd Annual Meeting of the American Society of Hematology (ASH). abstract 209. 

APML4 Yuen, S. L. S., Catalano, A., Brown, C., Iland, H., Cowley, M. J. and Kaplan, W. (2010) Identifying microRNA regulatory targets in 

acute promyelocytic leukaemia. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2010. 

2009 

APML4 

APML4 

MDS3 

Brown, C., Catalano, A., Supple, S., Hugman, A., Cowley, M. J., Kaplan, W. and Iland, H. (2009) A distinct set of microRNAs 

differentiates acute promyelocytic leukaemia according to FLT3 mutation status. Haematology Society of Australia and 

New Zealand (HSANZ) Annual Scientific Meeting 2009. 

Firkin, F., Lincz, L., Supple, S. and Iland, H. (2009) Arsenic pharmacodynamic factors impact on efficacy of treatment with 

arsenic trioxide (ATO) in combination with idarubicin plus all-trans retinoic acid for acute promyelocytic leukaemia (APML). 

Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2009. 

Kenealy, M. K., Seymour, J. F., Linda, C., Milner, A., Giri, P., Ho, S.-J., Benson, W., Nicol, A., Campbell, P., Prosser, I., Underhill, 

C., Cunningham, I., Mills, A. K., Szer, J., Presgrave, P. and Filshie, R. (2009) The tolerability of combination therapy with 

thalidomide and 5-azacitidine in patients with advanced myelodysplastic syndromes (MDS). Blood 114(22 (suppl.)). 51st 


SC01 Morrissey, C. O. (2009) Biological markers – Do they improve outcomes? The Australian Society for Microbiology, Mycology 

Master Class IV. 

CLL5 Mulligan, S. P., McInnes, S., Gill, D. and Seymour, J. F. (2009) The safety and tolerability of oral fludarabine, +/- oral 

cyclophosphamide and IV rituximab therapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) 

aged


Trial 

2008 

CML6 

APML4 

CML8 

CML8 

CML8 

NHL13 

Title 

Branford, S., Lawrence, R., Grigg, A., Seymour, J. F., Schwarer, A., Arthur, C., Rudzki, Z. and Hughes, T. (2008) Long term 

follow up of patients with CML in chronic phase treated with first-line imatinib suggests that earlier achievement of a major 

molecular response leads to greater stability of response. Blood 112 (11 (suppl.)). 50th Annual Meeting of the American 


Brown, C., Catalano, A., Supple, S., Hugman, A., Cowley, M. J., Kaplan, W. and Iland, H. (2008) Up-regulated expression of 

a large microRNA gene cluster in acute promyelocytic leukaemia. Haematology Society of Australia and New Zealand 

(HSANZ) Annual Scientific Meeting 2008. 

Ross, D. D. M., Grigg, A., Schwarer, A., Arthur, C., Loftus, K., Mills, A. K., Filshie, R., Columbus, R., Reynolds, J., Seymour, J. F., 

Branford, S. and Hughes, T. (2008) The majority of chronic myeloid leukaemia patients who cease imatinib after achieving 

a sustained complete molecular response (CMR) remain in CMR, and any relapses occur early. Blood 112(11 (suppl.)). 50th 


Ross, D., Grigg, A., Loftus, K., Seymour, J. F. and Hughes, T. (2008) High rate of sustained complete molecular response of chronic 

myeloid leukaemia after withdrawal of imatinib: progress of the ALLG CML8 study. Haematology Society of Australia and 

New Zealand (HSANZ) Annual Scientific Meeting 2008. abstract A148. 

Ross, D., Schafranek, L., Seymour, J. F., Branford, S. and Hughes, T. (2008) Heterogeneity of genomic BCR-ABL fusion 

sequences in chronic myeloid leukaemia patients. Haematology Society of Australia and New Zealand (HSANZ) Annual 

Scientific Meeting 2008. 

Schmitz, N., Ma, D., Mounier, N., Trneny, M., Linch, D., Bosly, A., Hagberg, H., Shpilberg, O., Ketterer, N., Glass, B., Gill, D., 

Gaulard, P., Moskowitz, C. and Gisselbrecht, C. (2008) Early relapses and failure to achieve complete remission are the main 

prognostic factors in CD20 diffuse large B-cell lymphoma (DLBCL) treated with R-ICE or R-DHAP followed by stem cell 

transplantation in the CORAL study. Ann Oncol 19(suppl. 4): 149-150. 10th International Conference on Malignant Lymphoma. 

NHL10 Trneny, M., Rieger, M., Osterborg, A., Pettengel, R., White, D. J., Gill, D., Walewski, J., Kuhnt, E., Loeffler, M., Pfreundschuh, M. 

and Ho, A. D. (2008) The addition of rituximab eliminates the negative prognostic impact of PMBCL compared to DLBCL 

in young patients with CD20-positive aggressive lymphomas receiving a CHOP-like chemotherapy: Results of a subgroup 

analysis of the Mabthera International Trial Group (MInT) study. Blood 112(11 (suppl.)). 50th Annual Meeting of the American 


NHLLOW4 van Oers, M. H. J., Van Glabbeke, M., Baila, L., Giurgia, L., Klasa, R., Marcus, R. E., Wolf, M., Kimby, E. and Hagenbeek, A. (2008) 

Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: Long-term outcome of the 

EORTC 20981 phase III randomized intergroup study. Blood 112(11 (suppl.)). 50th Annual Meeting of the American Society 

of Hematology (ASH). abstract 836. 

2007 

MM6 Brown, R., Spencer, A., Kennedy, N., Dolotin, M., Ho, P. J., Sze, D. M., Gibson, J. and Joshua, D. (2007) The presence of T cell 

clones is increased after thalidomide maintenance therapy (ALLG MM6) and is associated with an improved survival. 

Haematologica 92(suppl. 2): 168. XIth International Myeloma Workshop. 

LS08 Ho, P. J., Brown, R. D., Spencer, A., Jeffels, M., Daniher, D., Gibson, J. and Joshua, D. E. (2007) Thalidomide post-autologous 

stem cell transplant (ASCT) improves progression-free survival (PFS) in myeloma with normal but not upregulated FGFR3 

expression and may overcome the poor prognostic effect of T(4:14). Haematology Society of Australia and New Zealand 


CLL2 Karlsson, K. A., Stromberg, M., Jonsson, V., Mulligan, S. P., Liliemark, J. and Juliusson, G. (2007) Cladribine (CdA) gives longer 

response duration than fludarabine (F) and high-dose intermittent chlorambucil (Chl) as first-line treatment of symptomatic 

chronic lymphocytic leukemia (CLL). First results from the international randomized phase III trial. Blood 110(11 (suppl.)). 

49th Annual Meeting of the American Society of Hematology (ASH). abstract 630. 

CLL2 Karlsson, K., Stromberg, M., Jonsson, V., Mulligan, S., Liliemark, J. and Juliusson, G. (2007) Improved response duration 

from first-line treatment with cladribine (CdA) as compared to fludarabine (F) or high-dose intermittent chlorambucil (Chl). 

First results from the prospective international randomized phase III CLL study. 12th International Workshop on Chronic 

Lymphocytic Leukaemia. 

MDS3 Kenealy, M. K. and Seymour, J. F. (2007) Treatment of myelodysplastic syndromes with azacitidine and thalidomide Leuk Res 

31(suppl. 1): S7-8. 9th International Symposium on Myelodysplastic Syndromes abstract 12. 

– Lowenthal, R. M. and Seymour, J. F. (2007) O01 Twenty-five years of clinical trials for adult Acute Myeloid Leukaemia (AML) 

in Australia. Blood Reviews 21(suppl. 1): S67. International Society of Haematology Congress of the European & African 

Division. 

CML8 Ross, D. D., Bartley, P. A., Morley, A. A., Seymour, J., Branford, S. and Hughes, T. (2007) Detection of patient-specific BCR- 

ABL genomic DNA in CML patients with no detectable BCR_ABL by quantitative reverse transcriptase PCR. Haematologica 

92(suppl. 1): 212. 12th Congress of the European Hematology Association. 

CML8 Ross, D., Bartley, P. A., Morley, A. A., Seymour, J. F., Branford, S. and Hughes, T. P. (2007) Patient-specific BCR-ABL genomic 

DNA can be detected in CML patients in a complete molecular response defined by quantitative RT-PCR. Haematology 

Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2007. 

– Slavin, M. A., Thursky, K., Morrissey, O. C., Bardy, P. G., Worth, L., Blyth, C., Seymour, J. F. and Szer, J. (2007) Development of 

Australasian consensus antifungal guidelines. Proc Aust Soc Infect Dis Australian Society for Infectious Diseases Annual 



and Abstracts 

136


Trial 

2007 

MM6 

NHLLOW4 

Title 

Spencer, A., Prince, H. M., Roberts, A., Bradstock, K. and Porsser, I. (2007) Thalidomide improves survival when used following 

ASCT. Haematologica 92(suppl. 2): 41. XIth International Myeloma Workshop. 

van der Reijden, B. A., Van Oers, M. H. J., Tonnissen, E., Van Glabbeke, M., Giurgea, L., Klasa, R., Marcus, R. E., Wolf, M., Kimby, 

E., Van t Veer, M., Vranovsky, A., Holte, H. and Hagenbeek, A. (2007) BCL-2/IgH PCR values at the end of induction treatment 

are not predictive for progression free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized 

phase III intergroup trial. Blood 110(11 (suppl.)). 49th Annual Meeting of the American Society of Hematology (ASH). abstract 791. 

2006 

– Branford, S., Seymour, J. F., Grigg, A., Arthur, C., Lynch, K. and Hughes, T. (2006) Increasing frequency and marked stability of 

complete molecular response is observed in imatinib-treated CML patients with long-term follow up. Blood 108(11 (suppl.)). 

48th Annual Meeting of the American Society of Hematology (ASH). abstract 430. 

APML4 Campbell, L. J., Somana, K., Catalano, A., Dawson, M., Opat, S., Schwarer, A. and Iland, H. (2006) Unusual FISH patterns 

in APL lead to identification of a novel fusion gene. Haematology Society of Australia and New Zealand (HSANZ) Annual 


APML4 Catalano, A., Dawson, M. A., Somana, K., Opat, S. S., Campbell, L. J., Schwarer, A. and Iland, H. (2006) A novel fusion of RARA 

to the PRKAR1A gene, encoding the regulatory subunit type-Ia of cyclic AMP dependent protein linase A, in a variant acute 

promyelocytic leukaemia. Blood 108(11 (suppl.)). 48th Annual Meeting of the American Society of Hematology (ASH). 

abstract 2343. 

APML4 Catalano, A., Dawson, M. A., Somana, K., Opat, S., Campbell, L., Schwarer, A. and Iland, H. (2006) The PRKAR1A gene, encoding 

the regulatory subunit type-Ia of cyclic AMP dependent protein kinase A, is fused to RARA in a new variant acute promyelocytic 

leukaemia. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2006. 

AMLM13 Lane, S. W., Saal, R., Mollee, P., Grigg, A., Taylor, K., Seymour, J. F., Kennedy, G., Williams, B., Jones, M., Grimmett, K., Griffiths, 

V., Gill, D., Hourigan, M. and Marlton, P. (2006) Real-time quantitative polymerase chain reaction (RQ-PCR) monitoring of 

minimal residual disease (MRD) in core binding factor acute myeloid leukaemia (CBF AML). Blood 108(11 (suppl.)). 48th 


CML6 Ross, D. M., Branford, S., Reynolds, J., Koelmeyer, R. and Hughes, T. P. (2006) Molecular response at 6 months is a good early 

predictor of duration of treatment response in imatinib-treated chronic phase chronic myeloid leukaemia. Haematologica 

91(S1): 145-146. 11th Congress of the European Hematology Association. 

CML6 Seymour, J. F., Grigg, A., Reynolds, J., Schwarer, A. P., Herrmann, R., McDonald Taylor, K., Bradstock, K. F., Mills, A. K., 

Koelmeyer, R., Lynch, K. and Hughes, T. (2006) Two year data from a prospective safety study analyzing the consequences 

of imatinib mesylate inhibition of sensitive kinases other than bcr-abl in patients with previously untreated chronic phase 

CML. Blood 108(11 (suppl.)). 48th Annual Meeting of the American Society of Hematology (ASH). abstract 2147. 

MM6 Spencer, A., Prince, M., Roberts, A., Bradstock, K. and Prosser, I. (2006) First analysis of the Australasian Leukaemia and 

Lymphoma Group (ALLG) trial of thalidomide and alternate day prednisolone following autologous stem cell transplantation 

(ASCT) for patients with multiple myeloma (ALLG MM6). Blood 108(11 (suppl.)). 48th Annual Meeting of the American Society 


ALL2 Tavernier, E., Boiron, J.-M., Huguet, F., Bradstock, K., Vey, N., Kovacsovics, T., Delannoy, A., Fegueux, N., Fenaux, P., 

Stamatoullas, A., Tournilhac, O., Buzyn, A., Reman, O., Charrin, C., Boucheix, C., Gabert, J., Lheritier, V., Vernant, J.-P. and 

Thomas, X. (2006) Outcome of Treatment after First Relapse in Adults Patients with Acute Lymphoblastic Leukemia (ALL) 

Initially Treated by the LALA-94 Trial. Blood 108(11 (suppl.)). 48th Annual Meeting of the American Society of Hematology 


LY06 Walewski, J., Mead, G. M., Jack, A., Barrans, S. L., Radford, J., Clawson, S. M., Stenning, S. P. and Qian, W. (2006) Defining 

Burkitt's lymphoma with cytogenetics: LY10, a prospective clinicopathological study of dose-reduced CODOX-M/IVAC in 

patients with 100% Ki-67 staining B-cell non-Hodgkin's lymphoma. J Clin Oncol 24(18S). 2006 American Society of Clinical 

Oncology (ASCO) Annual Meeting. abstract 7557. 

HD3 Wirth, A., Grigg, A., Wolf, M., Davis, S., Hertzberg, M., Joseph, D., Johnston, C. and Reynolds, J. (2006) 2525: An Australasian 

Leukaemia Lymphoma Group- Trans Tasman Radiation Oncology Group Prospective Multicentre Study of Limited Chemotherapy 

and Involved Field Radiotherapy (IFRT) for Clinical Stage I-II Hodgkin Lymphoma (HL). International journal of radiation 

oncology, biology, physics 66(3): S502. 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology. 

2005 

MM6 Brown, R. D., Murray, A., Sze, D. M., Spencer, A., Ho, P. J., Gibson, J. and Joshua, D. E. (2005) The immunomodulatory action 

of thalidomide in patients with multiple myeloma involves a clonal expansion of late-differentiated cytotoxic effector cells. 

Blood 106(11 (suppl.)). 47th Annual Meeting of the American Society of Hematology (ASH). abstract 5108. 

LS09 Gandhi, M., Lambley, E., Marlton, P., Gill, D., Seymour, J., Wolf, M., Prince, M., Elliott, S. and Khanna, R. (2005) LAG-3 expressing 

lymphocytes suppress EBV latent membrane protein-specific T cell function in Hodgkin's lymphoma patients. Ann Oncol 

16(suppl. 5): v84. 9th International Conference on Malignant Lymphoma. 

NHLLOW4 Hagenbeek, A., Van Glabbeke, M., Teodorovic, I., Rozewicz, C., Klasa, R., Marcus, R. E., Wolf, M., Kimby, E. and van Oers, M. 

H. J. (2005) The role of rituximab maintenance treatment in relapsed follicular NHL: An interim analysis of the EORTIC 

randomized intergroup trial. Ann Oncol 16(suppl. 5): v52. 9th International Conference on Malignant Lymphoma. 

137


Trial 

2005 

CML6 

APML3 

Title 

Hughes, T. P., Branford, S., Reynolds, J., Koelmeyer, R., Seymour, J., Taylor, K., Guzzo-Pernell, N., Filshie, R., Arthur, C., 

Schwarer, A., Hertzberg, M., Copeman, M., Lynch, K. and Grigg, A. (2005) Maintenance of imatinib dose intensity in the first 

six months of therapy for newly diagnosed patients with CML is predictive of molecular response, independent of the ability 

to increase dose at a later point. Blood 106(11 (suppl.)). 47th Annual Meeting of the American Society of Hematology (ASH). 

abstract 164. 

Iland, H., Bradstock, K., Di Iulio, J. and Reynolds, J. (2005) Failure-free survival analysis of the ALLG APML3 trial incorporating 

ATRA, intensive idarubicin and triple maintenance combined with molecular monitoring in previously untreated acute 

promyelocytic leukemia. Haematologica Rep 1(7): 84. 4th International Symposium on Acute Promyelocytic Leukemia. 

LS08 Joshua, D., Sze, D., Jeffels, M., Brown, R., Spencer, A., Gibson, J. and Ho, P. J. (2005) Fibroblast growth factor receptor 3 

expression maintenance thalidomide treatment following high dose therapy in myeloma. Haematologica 90(suppl. 1): 79. 

10th International Myeloma Workshop. 

LS11 Murray, A., Brown, R., Ho, P. J., Sze, D., Gibson, J., Spencer, A. and Joshua, D. (2005) Increased number of T-cell receptor 

Vbeta expansions in patients on thalidomide maintenance therapy provides further evidence of the immunomodulatory 

action of thalidomide. Haematologica 90(suppl. 1): 182. 10th International Myeloma Workshop. 

LY04 O'Brien, P. (2005) Primary CNS lymphoma. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific 

Meeting 2005. 

NHL10 Pfreundschuh, M., Nickenig, C., Kannourakis, G., Erlanson, M., Hunter, A., Pytlik, R., White, D., Hellmann, A., Mandelli, F., Stahel, 

R., Kvaloy, S., Shpilberg, O., Jaeger, U., Hansen, M., Lopez-Guillermo, A., Lehtinen, T., Corrado, C., Scheliga, A., Milpied, N., 

Kuhnt, E., Loeffler, M. and al., e. (2005) Rituximab as a "chemo-equalizer" in the MINT (Mabthera International Trial Group) 

study: Treatment results of CHOP-21, CHOEP-21, MACOP-B and PMITCEBO with and without rituximab in young goodprognosis 

patients with aggressive lymphomas. Ann Oncol 16(suppl. 5): v98. 9th International Conference on Malignant 

Lymphoma. abstract 208. 

LY05 Rule, S., Burton, C., Waleski, J., Jack, A. and Seymour, J. (2005) A randomised phase II study of fludarabine/ 

cyclophosphamide +/- rituximab in patients with untreated mantle cell lymphoma. Ann Oncol 16(suppl. 5): v95. 9th 

International Conference on Malignant Lymphoma. 

MM6 Spencer, A., Kennedy, N., Roberts, A., Neeman, T., Schran, H. and Lynch, K. (2005) Interim safety analysis of the randomized 

multicenter ALLG MM6 trial of post-autologous stem cell transplant triple maintenance therapy. Haematologica 90(suppl. 

1): 133. 10th International Myeloma Workshop. 

NHLLOW4 Van Oers, M. H. J., Van Glabbeke, M., Teodorovic, I., Rozewicz, C., Klasa, R., Marcus, R. E., Wolf, M., Kimby, E. and Hagenbeek, A. 

(2005) Chimeric anti-CD20 monoclonal antibody (rituximab;mabthera) in remission induction and maintenance treatment 

of relapsed/resistant follicular non-Hodgkin's lymphoma: Final analysis of a phase III randomized intergroup clinical trial. 


CML6 White, D. L., Branford, S., Saunders, V. A., Lynch, K., Grigg, A., To, L. B. and Hughes, T. P. (2005) In imatinib treated CML patients 

with low baseline IC50, early molecular response is highly predictive of longer term molecular outcome. In patients with 

high IC50, other prognostic indicators are needed. Blood 106(11 (suppl.)). 47th Annual Meeting of the American Society 


CML6 White, D. L., Saunders, V. A., Branford, S., Lynch, K., To, L. B. and Hughes, T. P. (2005) The in-vivo level of imatinib induced 

kinase inhibition achieved in de-novo CML patients during the first 28 days of therapy is a powerful predictor of molecular 

outcome. Blood 106(11 (suppl.)). 47th Annual Meeting of the American Society of Hematology (ASH). abstract 436. 

CML6 White, D., Saunders, V., Branford, S., Lynch, K., To, L. B. and Hughes, T. (2005) Predictive value of two assays measuring kinase 

inhibition by imatinib in CML patients. Haematology Society of Australia and New Zealand (HSANZ) Annual Scientific 

Meeting 2005. 

HD3 Wirth, A., Grigg, A., Wolf, M., Davis, S., Hertzberg, M., Joseph, D., Johnson, C. and Reynolds, J. (2005) Risk and response 

adapted treatment for early stage Hodgkin's lymphoma (ESHL): Three year results of an Australasian Leukaemia and 

Lymphoma Group/Trans-Tasman Radiation Oncology Group study. Haematology Society of Australia and New Zealand 


2004 

CML6 Branford, S., Rudzki, Z., Grigg, A., Seymour, J., Browett, P., Taylor, K., Herrmann, R., Schwarer, A., Arthur, C., Lynch, K. and 

Hughes, T. (2004) The frequency of detection of BCR-ABL mutations in imatinib treated patients with chronic phase CML 

who attain a complete cytogenetic response (CCR) does not diminish with increasing duration of CCR but the associated 

loss of response is usually gradual. Blood 104(11 (suppl.)). 46th Annual Meeting of the American Society of Hematology 


PT1 Green, A., Campbell, P., Buck, G., Wheatley, K., East, C., Bareford, D., Wilkins, B., Van der Walt, J., Reilly, J. and Harrison, C. 

(2004) The Medical Research Council PT1 trial in essential thrombocythemia. Blood 104(11 (suppl.)). 46th Annual Meeting 

of the American Society of Hematology (ASH). abstract 6. 

AMLM11 Grigg, A. P., Shuttleworth, P., Bardy, P., Gibson, J., Durrant, S. and Bradstock, K. (2004) Non-myeloablative allografts in adults 

with intermediate prognosis acute myeloid leukaemia (AML) in first complete remission (CR1). Hematol J 89(5): S160. 9th 

Congress of the European Hematology Association. abstract 461. 

CML6 Hughes, T., Branford, S., Reynolds, J., Seymour, J., Taylor, K., Guzzo-Pernell, N., Filshie, R., Arthur, C., Schwarer, A., Hertzberg, 

M., Rudzki, Z., Copeman, M., Lynch, K. and Grigg, A. (2004) Higher-dose imatinib (600 mg/Day) with selective intensification 

in newly diagnosed CML patients in chronic phase; Cytogenetic response rates at 12 months are superior to IRIS. Blood 

104(11 (suppl.)). 46th Annual Meeting of the American Society of Hematology (ASH). abstract 1001. 


and Abstracts 

138


Trial 

2004 

CLL2 

Title 

Karlsson, K., Stromberg, M., Jonsson, V., Gill, D., Hammerstrom, J., Wallvik, J., Mulligan, S., Bradstock, K., Liliemark, J. and 

Juliusson, G. (2004) Cladribine (CdA) or fludarabine (F) or high-dose intermittent chlorambucil (Chl) as first-line treatment 

of symptomatic chronic lymphocytic leukemia? First interim analysis of data from the international randomized phase III 

trial. Blood 104(11 (suppl.)). 46th Annual Meeting of the American Society of Hematology (ASH). abstract 3470. 

– Lickliter, J., Arthur, C., D'Rozario, J., Hui, C.-H., Szer, J., Taylor, K., Watson, A.-M., McCarron, J., Lynch, K. and Bradstock, K. 

(2004) Phase II pilot study of imatinib mesylate combined with induction chemotherapy in blast-phase CML and Ph+ ALL. 


NHL10 Pfreundschuh, M. G., Trümper, L., Ma, D., Österborg, A., Pettengell, R., Trneny, M., Shepherd, L., Walewski, J., Zinzani, P.-L. 

and Loeffler, M. (2004) Randomized intergroup trial of first line treatment for patients


Trial 

Title 

2003 

APML3 Iland, H., Bradstock, K., Li, C., Springall, F., Ayling, J., Catalano, A., Supple, S., Todd, A., Applegate, T. and Mokany, E. (2003) 

Results of the APML3 trial of ATRA, intensive idarubicin and triple maintenance combined with molecular monitoring in 

acute promyelocytic leukemia (APL): a study by the Australasian Leukaemia and Lymphoma Group (ALLG). 45th Annual 

Meeting of the American Society of Hematology (ASH). 

NHL10 Pfreundschuh, M. G., Trümper, L., Ma, D., Österborg, A., Pettengell, R., Trneny, M., Shepherd, L., Walewski, J., Zinzani, P.-L. 

and Loeffler, M. (2003) Randomised intergroup trial of first line treatment for patients


Trial 

2001 

HDNHL3 

HDNHL2 

AMLM7 

APML3 

APML3 

APML3 

Title 

Biagi, J. J., Prince, H. M., Smith, C., Abdi, E., Leahy, M., Falkson, C., Wolf, M., Januszewicz, H., Seymour, J. F., Stone, J. and Dale, 

B. (2001) Modified DICE chemotherapy in patients with lymphoma: Results of phase II ALLG study. Haematology Society 

of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2001. 

Bosly, A., Lepage, E., Grigg, A., Salles, G., Gisselbrecht, C., Radford, J., Rossi, A., Trneny, M., Lopez-Guillermo, A., Holte, H., 

Sebban, C., Hagberg, H., Leal da Costa, F., Lafleur, F. and Coiffier, B. (2001) Interferon alfa2b does not prolong response after 

intensive therapy and autologous stemm cell transplantation for relapsing lymphoma. An international randomized study 

on 221 patients. 43rd Annual Meeting of the American Society of Hematology (ASH). 

Bradstock, K., Young, G., Lowenthal, R. and Matthews, J. (2001) Intensive chemotherapy in induction and consolidation for 

de novo adult acute myeloid leukemia using sequential courses of high dose cytarabine, idarubicin and etoposide: Randomized 

trial of the Australasian Leukaemia and Lymphoma Group (ALLG). Blood 98(11 (suppl.)). 43rd Annual Meeting of the American 

Society of Hematology (ASH). abstract 462a. 

Iland, H. and Bradstock, K. (2001) APML3: An Australasian Leukaemia and Lymphoma Group (ALLG) trial of ATRA and 

intensive idarubicin in acute promyelocytic leukaemia (APL). Joint International Congress on APL and Differentiation 

Therapy. 

Iland, H., Ayling, J., Li, C. and Catalano, A. (2001) Internal tandem duplication (ITD) mutations of FLT3 in APL. Australasian 

Leukaemia and Lymphoma Group (ALLG) and the Kanematsu Laboratories. Haematology Society of Australia and New 

Zealand (HSANZ) Annual Scientific Meeting 2001. 

Iland, H., Ayling, J., Li, C. and Catalano, A. (2001) Internal tandem duplication (ITD) mutations of FLT3 in APL. Australasian 

Leukaemia and Lymphoma Group (ALLG) and the Kanematsu Laboratories. Joint International Congress on APL and 

Differentiation Therapy. 

– Saal, R., Marlton, P., Timson, G., Waugh, M., Springall, F., Grimmett, K., Gill, D. and Iland, H. (2001) Rapid RT-PCR screening 

assay incorporating multiplexed validated control genes for CBF rearrangements at diagnosis in AML. Haematology Society 

of Australia and New Zealand (HSANZ) Annual Scientific Meeting 2001. 

HDNHL1 Wirth, A., Wolf, M., Prince, M., MacCleod, C., Gibson, J., Roos, D., Dart, G., Davis, S., Schwarer, T. and Grigg, A. (2001) Optimal 

timing of involved-field radiotherapy (IFRT) with transplantation for Hodgkin's disease (HD) and non-Hodgkin's lymphoma 

(NHL): An Australasian Leukaemia and Lymphoma Group pilot study. International Society of Radiation Oncology. 

– Wolf, M. (2001) Report of the ALLG trials in diffuse large cell lymphoma. 1st International Lunenberg Lymphoma Workshop. 

– Wolf, M. (2001) Update on the intermediate-grade lymphoma trials of the ALLG. Haematology Society of Australia and New 

Zealand (HSANZ) Annual Scientific Meeting 2001. 

2000 

NHL7 

Wolf, M., Matthews, J., Stone, J., Benson, W., Browett, P., Dart, G., Abdi, E., Grigg, A., Ding, J., Gurney, H., Bonaventura, A., 

Marlton, P., Herrmann, R. and Ellis, D. (2000) Dose intensification does not improve outcome in aggressive non-Hodgkin's 

lymphoma (NHL). Report of a randomized trial by the Australasian Leukaemia and Lymphoma Group (ALLG). 42nd Annual 

Meeting of the American Society of Hematology (ASH). 

ALSG Meeting Presentations and Abstracts 

Trial 

1995 

CLL1 

1993 

AMLM2 

Title 

Mulligan, S. P., Eliadis, P., Dale, B., Bunce, I., Bashford, J., Page, F., Matthews, J. and Bradstock, K. (1995) 2-Chlorodeoxyadenosine 

(2-CDA) in previously untreated chronic lymphocytic leukaemia (CLL). Blood 86(suppl.1): 349a. 37th Annual Meeting of the 

American Society of Hematology (ASH). 

Lowenthal, R. M., Matthews, J. P., Bishop, J. F., Bunce, I. H., Cobcroft, R. G., Eliadis, P., Harvey, M. P., Herrmann, R. P., 

Januszewicz, E. H., Kimber, R. I., Lindenmann, R., Manoharan, A., Page, F. J., Rooney, K. F., Rosenfeld, D., Taylor, K. M., 

Wiley, J. S., Wolf, M. M. and Young, G. A. R. (1993) Idarubicin, cytosine arabinoside in standard or high dose, and etoposide: 

combinations giving high remission rates in adult acute myeloid leukemia (AML). Pilot studies of the Australian Leukaemia 

Study Group (ALSG). 35th Annual Meeting of the American Society of Hematology (ASH). 

1987 

– Lowenthal, R. M. (1987) A possible special role for oral idarubicin in the treatment of leukemia following myelodysplastic 

syndrome.: 50–55. 4th International Symposium on Therapy of Leukemia. Proceedings of the session in idarubicin in the 

treatment of acute leukemia. 

141

Abbreviations 

ADR 

Adverse drug reaction 

CRF 

Case report form 

MRD 

Minimal residual disease 

AE 

Adverse event 

CSF 

Cerebral spinal fluid 

MSD 

Merck Sharp and Dohme 

AGITG 

ALL 

ALLG 

ALTG 

AML 

ANZ BCTG 

ANZCHOG 

ANZGOG 

ANZCTR 

ANZMTG 

ANZUP 

APML 

ASSG 

BaCT 

BCR–ABL 

BM 

BMAT 

BMS 

BMT 

CA 

CBF 

CLL 

CML 

CMR 

CNS 

CNSL 

COGNO 

COSA 

Australasian Gastro- 

Intestinal Trials Group 

Acute lymphoblastic 

leukaemia 

Australasian Leukaemia 


Australasian Lung Cancer 

Trials Group 

Acute myeloid leukaemia 

Australian New Zealand 

Breast Cancer Trials Group 

Australian and New Zealand 

Children’s Haematology 

Oncology Group 

Australia New Zealand 

Gynaecological Oncology 

Group 

Australian New Zealand 

Clinical Trials Registry 

Australia and New Zealand 

Melanoma Trials Group 

Australian and New Zealand 

Urogenital and Prostate 

Cancer Trials Group 

Acute promyelocytic 

leukaemia 

Australasian Sarcoma 

Study Group 

Centre for Biostatistics 

and Clinical Trials 

An oncogene fusion protein 

consisting of BCR and ABL 

Bone marrow 

Bone Marrow Aspirate 

and trephine 

Bristol Myers Squibb 

Bone Marrow Transplant 

Cancer Australia 

Core binding factor 

Chronic lymphocytic 

leukaemia 

Chronic myeloid leukaemia 

Complete Molecular 

Response 

Central nervous system 

Central nervous system 

lymphoma 

Cooperative Trials Group 

for Neuro-Oncology; 

Clinical Oncology Society 

of Australia 

CT Computed Tomography 

(=CAT scan) 

CTA Clinical Trials Australia 

CTN Clinical trial notification 

CTRA Clinical trial research 

agreement 

DGC Disease Group Committee 

DLT Dose limiting toxicity 

DNA Deoxyribonucleic acid 

EC Ethics Committee 

ECOG Eastern Co-operative 


eCRF Electronic case report form 

EORTC European Organisation for 

Research and Treatment 

of Cancer 

FAC Finance Audit Committee 

FCR Fludarabine, 

cyclophosphamide, 

rituximab chemotherapy 

Flt3 Fms-like tyrosine kinase 3 

GCP Good Clinical Practice 

GELA Groupe d’Etude des 

Lymphomes de l’Adulte. Trial 

Cooperative group France 

GSK GlaxoSmithKline 

HCVAD Hyper-CVAD 

(Cyclophosphamide, 

Vincristine, Doxorubicin, 

Dexamethasone) 

HD Hodgkins Disease 

HE Health Economics 

HOMER Harmonisation of multi-centre 

ethical review 

HREC Human Research Ethics 

Committee 

IB Investigator’s Brochure 

ICE Chemotherapy regimen- 

Ifosfamide, carboplatin 

and etoposide 

ICH GCP International Conference 

on Harmonisation, 

Good Clinical Practice 

IIT Investigator-initiated trial 

MBVP Chemotherapy regimen- 

Methotrexate, Teniposide, 

BCNU and Prednisolone 

MDS Myelodysplastic Syndrome 

MM Multiple myeloma 

MMR Major molecular response 

MOU 

NCI CTC 

NHL 

NHMRC 

OS 

PBAC 

PBS 

PC4 

PCNSL 

PET 

PFS 

PI 

PICF 

PK 

POCOG 

QOL 

SAC 

SAE 

SDMC 

STIM 

SUSAR 

TB 

TCDM 

TGA 

TMC 

TROG 

VCA 

VMIA 

WHO 

Memorandum of 

Understanding 

National Cancer Institute 

Common Toxicity Criteria 

Non hodgkin lymphoma 

National health and medical 

research council 

Overall survival 

Pharmaceutical Benefits 

Advisory Committee 

Pharmaceutical Benefit 

Scheme 

Primary Care Collaborative 

Cancer Clinical Trials Group 

Primary central nervous 

system lymphoma 

Positive emission 

tomography 

Progression free survival 

Principal Investigator 

Patient Information and 

Consent Form 

Pharmacokinetics 

Psycho-Oncology 

Co-operative Research Group 

Quality of Life 

Scientific Advisory 

Committee 

Serious adverse event 

Safety and data 

monitoring committee 

French trial: Stop Imatinib 

Suspected unexpected 

serious adverse reaction 

Tissue Bank 

Trial Centre Data Manager 

Therapeutic Goods 

Administration 

Trial Management Committee 

Trans-Tasman Radiation 


Victorian Cancer Agency 

Victorian-Managed 

Insurance Authority 

World Health Organization 

Publications Abbreviations 

142

The Australasian Leukaemia 

and Lymphoma Group’s 2011 

Research Report received 

funding from the Australian 

Government through Cancer 

Australia. 

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East Melbourne VIC 3002

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