Mid-term report 2013 - The European LeukemiaNet
Mid-term report 2013 - The European LeukemiaNet
Mid-term report 2013 - The European LeukemiaNet
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<strong>Mid</strong>-<strong>term</strong> <strong>report</strong><br />
08-RNP-071
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Content<br />
1. ELN objectives ..................................................................................................................................... 3<br />
2. ELN activities: scientific quality and impact ......................................................................................... 4<br />
2.1. Scientific visibility .......................................................................................................................... 4<br />
2.1.1. WP1 (NMC) ........................................................................................................................... 4<br />
2.1.2. WP2 (ELIC)............................................................................................................................ 4<br />
2.1.3. WP 3 (CICS): ......................................................................................................................... 4<br />
2.1.4. WP 4 (CML in cooperation with WP 17 Registry and Biometry): .......................................... 5<br />
2.1.5. WP5 (AML): ........................................................................................................................... 5<br />
2.1.6. WP6 (ALL): ............................................................................................................................ 6<br />
2.1.7. WP7 (CLL ERIC): .................................................................................................................. 6<br />
2.1.8. WP8 (MDS):........................................................................................................................... 7<br />
2.1.9. WP9 (MPD):........................................................................................................................... 8<br />
2.1.10. WP10 (Diagnostics): ............................................................................................................ 8<br />
2.1.11. WP11 (cytogenetics): .......................................................................................................... 9<br />
2.1.12. WP12 (minimal residual disease): ....................................................................................... 9<br />
2.1.13. WP13 (Next generation sequencing): ............................................................................... 10<br />
2.1.14. WP14 (SCT): ..................................................................................................................... 10<br />
2.1.15. WP 15 (infectious diseases): ............................................................................................. 11<br />
2.2. Meeting and exchange activities ................................................................................................ 12<br />
2.3. Establishment of databases, registries, studies or similar infrastructures ................................. 13<br />
2.4. Collaboration with other scientific networks, organizations and industry ................................... 13<br />
3. <strong>European</strong> added value and ELN visibility .......................................................................................... 14<br />
4. ELN management and finances ........................................................................................................ 15<br />
5. Publicity and publications: scientific quality and impact .................................................................... 16<br />
6. Future planning, recommendations and conclusions ........................................................................ 16<br />
7. Appendices ........................................................................................................................................ 17<br />
7.1. Appendix I - List of Steering Committee ELN – ELN/ESF .......................................................... 17<br />
7.2. Appendix II - List of the supporting ESF Member Organisations ............................................... 18<br />
7.3. Appendix III – ELN activities ....................................................................................................... 19<br />
7.3.1. Meeting and exchange activities ......................................................................................... 19<br />
7.3.2. Lectures ............................................................................................................................... 20<br />
7.4. Appendix IV – <strong>European</strong> added value and ELN visibility ........................................................... 22<br />
7.4.1. New trials in the ELTR ......................................................................................................... 22<br />
7.4.2. Registries ............................................................................................................................. 23<br />
7.5. Appendix V – ELN management and finances........................................................................... 24<br />
7.6. Appendix VI – Publicity and publications: scientific quality and impact ..................................... 25<br />
7.6.1. Recommendations and guidelines ...................................................................................... 25<br />
7.6.2. Public outreach founded by ESF ......................................................................................... 27<br />
7.6.3. Public outreach not-founded by ESF ................................................................................... 27<br />
7.6.4 Scientific publications ........................................................................................................... 28<br />
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1. ELN objectives<br />
<strong>The</strong> major objectives of the ELN are to promote research on leukemias with the goal to cure<br />
these diseases. International cooperation, communication and networking between<br />
researchers are key to successful progress. This is achieved by novel approaches in<br />
research and treatment strategies among 113 leading national leukemia study groups and<br />
their 109 interdisciplinary partner groups. During the funding period ELN has expanded its<br />
network to outside Europe with new cooperation partners in Armenia, Kirgistan, Israel, and<br />
the USA. Prospective partners that are interested to join the ELN in the next months are<br />
located in Uruguay, Australia, Canada, Taiwan, Korea, China, Japan, Egypt, and Saudi<br />
Arabia. All in all, the ELN brings together about 1180 researchers and physicians in 193<br />
participating institutions in 39 countries, improving research on leukemia.<br />
<strong>The</strong> support of international leukemia working groups and the advanced communication and<br />
networking structures have led to joint leukemia research activities as e.g. the initiation of<br />
new research projects, clinical studies and leukemia registries (see appendix 7.3.2.), and the<br />
implementation of ELN management recommendations (see appendix 7.5.1.).<br />
Other projects improved the standardized evaluation and monitoring to optimize diagnosis<br />
and treatment of leukemia across Europe (for instance the harmonized molecular monitoring<br />
of CML in Europe) and the definitions of relevant study endpoints (e.g. for MPN).<br />
<strong>European</strong> clinical trials are important to gain a broad patient collective, to discuss and<br />
compare results and offer optimal treatment for patients. Current activities include consensus<br />
decisions on further study endpoints, registries for each leukemia, common standardization<br />
procedures and classification systems at diagnosis and follow up (molecular monitoring,<br />
cytogenetics, minimal residual disease assessment) during treatment as well as<br />
harmonization of data evaluation and <strong>report</strong>ing.<br />
<strong>The</strong> ELN offers innovative ideas, a portfolio of new disease markers, novel targets, drugcombinations<br />
and dose-optimization studies, vaccination approaches and high-throughput<br />
technologies such as next generation sequencing in a harmonized setting of <strong>European</strong><br />
collaborations. All WPs and their projects are the basis for high quality research, for<br />
<strong>European</strong> excellence in the field of leukemia and for cure of leukemia. This impacts patients,<br />
health care economics and society and results in faster implementation of new treatments for<br />
patients across Europe.<br />
For the successful transfer of new research and treatment results from bench to bedside, the<br />
training of hematologists is essential. <strong>The</strong> ELN has regularly organized educational<br />
workshops for interested hematologists, with a special focus on young physicians from all<br />
over Europe (see appendix 7.2.1.). In addition, educational and research symposia and<br />
workshops have been held at major hematologic congresses (see appendix 7.2.1.).<br />
Spread of excellence was mediated by original articles published in medical journals (full list<br />
see appendix 7.5.4) and printing brochures and books. <strong>The</strong> ELN promotes the standard<br />
treatment recommendations by distributing reprints of recommendations free of charge.<br />
Interactions with other organizations that have an interest in the leukemias like EHA, EBMT,<br />
WBMT and WHO regarding clinical trial guidelines and infrastructures are already ongoing.<br />
<strong>The</strong> ELN has connected the <strong>European</strong> Trial Registry (ELTR) to the WHO website, supports<br />
further interactions and streamlines common goals.<br />
No deviation of project goals occurred so far.<br />
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2. ELN activities: scientific quality and impact<br />
<strong>The</strong> project has fostered the internationally visible ELN-activities, and the established<br />
communication and networking structures could be extended.<br />
2.1. Scientific visibility<br />
<strong>The</strong> implementation of ELN management recommendations was successfully promoted to<br />
improve the understanding and treatment of the different leukemia entities in Europe (entire<br />
list see attached). This is achieved by novel approaches in management and research<br />
among 113 leading national leukemia study groups and their 109 interdisciplinary partner<br />
groups. <strong>The</strong> network integrates more than 1000 researchers and physicians in 193<br />
participating institutions in 39 countries, promoting research on all types of leukemia.<br />
2.1.1. WP1 (NMC)<br />
<strong>The</strong> central office of the <strong>European</strong> <strong>LeukemiaNet</strong> is the operational headquarter. <strong>The</strong><br />
organisation of the regular meetings and the assistance in the preparation of working group<br />
meetings was one of the main tasks. NMC also took care of financial matters, funding, help<br />
with applications to network members and <strong>report</strong>ing on their activities.<br />
NMC also manages the ELN Foundation in <strong>term</strong>s of promotion, financing and administration.<br />
Goal of the ELN foundation is the collection of donations in support of activities of the ELN.<br />
Target groups of the ELN foundation are (pharmaceutical) companies, private persons and<br />
major Foundations. A fundraiser is in charge to contact these target groups.<br />
2.1.2. WP2 (ELIC)<br />
WP2 has prepared a sponsoring concept together with WP1 to gain funding for the ELN. This<br />
will enable the ELN to accept funding for service in return. <strong>The</strong> ELN will in future have the<br />
possibility for sponsoring contracts as an additional tool to get financial support. Aim of the<br />
sponsoring concept is to generate a budget for the ELN which is distributed according to<br />
transparent criteria. Target groups will be pharmaceutical companies (one-stop-shop).<br />
ELIC is continuously updating the ELN homepage in regards to meetings and conferences,<br />
clinical trials, project updates, dissemination of news and the set-up of new project sites.<br />
<strong>The</strong> leukemia trial registry (ELTR) has currently registered approximately 90 <strong>European</strong><br />
leukemia trials and was recently restructured. ELIC also links to and updates the homepage<br />
of the public-private partnership “<strong>European</strong> treatment and outcome study (EUTOS) for CML”.<br />
Yearly, an Information Letter is prepared for the symposium in January (in cooperation with<br />
WP1, NMC), highlighting the current progress on projects, collaborations, meetings, website<br />
content and lists upcoming meetings (see appendix 7.2.1.). It fosters cooperation amongst<br />
network members and informs the public on hot topics in leukemia.<br />
In the name of the ELN ELIC together with the NMC coordinate ELN activities around a<br />
response to the ‘clinical trials directive’ 2001/20/ec concept paper.<br />
2.1.3. WP 3 (CICS):<br />
WP 3 is providing expertise in informatics and statistics to the ELN, in particular in the field of<br />
AML and CML. Statistical advice regarding registries and clinical trials are offered to all ELN<br />
members. A multilingual portal for medical forms is provided to support design of case <strong>report</strong><br />
forms in ELN studies.<br />
In collaboration with WP13 expertise for planning and analysis of biomarker studies is<br />
provided with a focus on next-generation-sequencing. <strong>The</strong> leukemia gene atlas<br />
(http://www.leukemia-gene-atlas.org/) is available for ELN members to support interpretation<br />
of gene profiling findings.<br />
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2.1.4. WP 4 (CML in cooperation with WP 17 Registry and Biometry):<br />
Recommendations: An update of the ELN management recommendations for CML has<br />
recently been accepted for publication in Blood (June <strong>2013</strong>). <strong>The</strong> second version of the<br />
recommendations published in 2009 in JCO was listed under the 50 most cited papers of<br />
JCO (see http://jco.ascopubs.org/content/30/28/3431.full).<br />
Studies<br />
• EURO-SKI (EURO-StopKinaseInhibitors): a multinational effort in CML, which is<br />
planned in 10 countries. In this study an expensive medication planned for life will be<br />
stopped under controlled conditions and the time free of disease (major molecular<br />
response) will be assessed. <strong>The</strong> study is based on the experience of the French<br />
STIM trial (Mahon et al. Lancet Onc 2010). <strong>The</strong> study could result in a major impact<br />
on the quality of life of patients and on the socio-economic burden. <strong>The</strong> study design<br />
was discussed in several meetings. In June 2012 the 1 st patient was recruited. As of<br />
May 31 st , nearly 200 patients are preregistered in 5 countries. Additional countries will<br />
open the study soon. A first interim analysis is planned at the end of <strong>2013</strong> after the<br />
inclusion of the first 200 patients with a minimum follow-up of 6 months. <strong>The</strong> study will<br />
give major insights on when best to stop TKI therapy in CML patients.<br />
• First-line studies with 2 nd generation TKI in combination with IFN were started in<br />
France, Germany (in cooperation with Switzerland and the Czech Republic) and the<br />
Nordic CML Study group<br />
Registries:<br />
• <strong>The</strong> EUTOS population-based prospective CML registry has registered 2936 CML<br />
patients by 31.12.2012 provided by 27 study groups from 25 <strong>European</strong> countries.<br />
Over a 3-year period the study is performed via the EUTOS for CML project, a<br />
collaborating project of WP 4 and Novartis. In <strong>2013</strong>, the final evaluation of the project<br />
will be carried out to be published in 2014. <strong>The</strong> validation of the EUTOS score based<br />
on these cohorts was prepublished in LEUKEMIA on June 11, <strong>2013</strong>.<br />
• A registry on pregnancies in female and male patients with CML is planned on a<br />
<strong>European</strong> basis. This was discussed at several WP4 meetings. CML Pregnancy<br />
Registries from Russia and Italy were launched as a joint ELN project in February<br />
<strong>2013</strong>. In March-May an information letter about the ELN CML Registry was provided<br />
to colleagues of all ELN countries. In June, representatives from 17 countries had<br />
expressed interest to join this registry.<br />
Other projects:<br />
<strong>The</strong> standardization of molecular monitoring in CML especially on deep molecular response<br />
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Other topics<br />
• Further progress and experience in the field of molecular markers and new drugs<br />
targets have been achieved. A major goal is still the implementation of minimal<br />
residual disease measurements in clinical trials improving the risk stratification in AML<br />
and the integrated risk-score. A cooperation between HOVON (the Haemato<br />
Oncology Foundation for Adults in the Netherlands), SAKK (schweizerische<br />
Arbeitsgemeinschaft für klinische Studien in der Krebsforschung), and the German<br />
AML-Cooperative Group on joint trials and analyses was started first results were<br />
published<br />
• Registry: Good progress was made in the <strong>European</strong> APL registry. A total of xx<br />
patients are registered so far. In addition in Germany several registry are running to<br />
collect data outside of clinical studies.<br />
• A web based scoring system for older AML patients was developed on the basis of<br />
meta-analysis (Krug et al Lancet 2010).<br />
• Multiple approaches and experiences were <strong>report</strong>ed on the field of allogeneic SCT<br />
2.1.6. WP6 (ALL):<br />
<strong>The</strong> successful national <strong>European</strong> study groups for ALL, (EWALL) aim to combine their<br />
efforts in order to create a world-wide leading research group for adult ALL. Integrating<br />
activities are of major importance and include the development of standardized laboratory<br />
procedures for diagnostic confirmation, an overview on prognostic factors and on ongoing<br />
<strong>European</strong> studies in ALL within a study registry. Phase I-III intergroup studies and the<br />
combination and standardization of methods, definitions and clinical application of MRD are<br />
jointly executed research activities.<br />
Recommendations:<br />
<strong>The</strong> EWALL has recently published the value of pre-autologous SCT MRD in Ph+ and Phnegative<br />
ALL patients (S. Giebel, Eur J Cancer. 2012)<br />
Studies:<br />
Different national ALL study groups of the EWALL (<strong>European</strong> Working group on ALL) are<br />
leading in the exploration of new antibodies in the treatment of adult ALL with antibody<br />
studies on Blinatumomab and Inotuzumab. <strong>The</strong>re are several studies on Ph+ ALL going on,<br />
focusing on elderly patients and Nilotinib and Imatinib in rotation. <strong>The</strong>re are various pilot<br />
studies with new substances going on in the EWALL.<br />
New studies with the application of Peg-asparaginase have been presented for the different<br />
national EWALL study groups .<br />
New joined retrospective analyses within the EWALL are planned:<br />
• T-ALL risk factors:<br />
• Value of pre-allogeneic SCT MRD level in Ph-negative ALL patients:<br />
• Retrospective analysis the value of pre-allogeneic SCT MRD.<br />
• Pre-allogeneic SCT molecular status in Ph+ ALL patients<br />
• Value of monosomal karyotypes in adult ALL patients<br />
• CNS prophylaxis in patients receiving SCT<br />
• CNS relapse incidence and management in Ph+ ALL patients<br />
• Secondary malignancies after ALL therapy in adult<br />
2.1.7. WP7 (CLL ERIC):<br />
<strong>The</strong> <strong>European</strong> Research Initiative on CLL (ERIC) has fostered scientific credibility,<br />
competence and excellence of ERIC as a <strong>European</strong> non-profit organization. Furthermore, it<br />
connects the <strong>European</strong> <strong>LeukemiaNet</strong> and EHA as interacting <strong>European</strong> promoters of<br />
competence in hematology and leukemia. Now there are 366 members from 36 countries<br />
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involved in ERIC.<br />
Molecular studies:<br />
<strong>The</strong> accreditation programme for IGHV gene analysis: focus was on external quality<br />
assessment in diagnostic laboratories and how to provide certificates<br />
Clinical Studies<br />
• ERIC Phase IV trial on Ofatumumab in CLL therapy. international CLL registry for<br />
spontaneous regression in CLL. <strong>The</strong> aims of the project were shown such as to<br />
facilitate studies in ERIC.<br />
Completed and on-going projects are shared on the website www.ericll.org.<br />
2.1.8. WP8 (MDS):<br />
WP 8 is now integrated into the Working group of the <strong>European</strong> Hematology association,<br />
EHA MDS Working group.<br />
<strong>The</strong> results provided by the WP8 of the ELN have major impact on new diagnostic strategies<br />
in MDS. This is of particular importance since new drugs are emerging in both lower and<br />
higher risk MDS. In addition, the Working Group may provide evidence that flow cytometry<br />
may add in new prognostic scoring systems. To this end the Pavia Meeting in 2011 and<br />
Amsterdam meeting in 2012 focused on designing prospective multicenter studies to<br />
emphasize diagnostics and prognostics in MDS which might be included in the new WHO<br />
classification of hematopoietic neoplasms in [anticipated] 2015.<br />
A major goal of WP8 is to set up an international MDS clinical trial platform to standardize<br />
methodology of diagnosis (flow cytometry), therapy (Vidaza, Lenalinomide) and follow up in<br />
MDS and to allow better comparison of results.<br />
<strong>The</strong> platform is now active EMSCO (<strong>European</strong> Leukemia Net Myelodysplastic Syndromes<br />
Studies Coordination Office)<br />
Recommendations:<br />
• <strong>The</strong>rapeutic guidelines on treatment of MDS can be found on the website:<br />
http://mds.haematologica.org<br />
• In addition, in the almost finalized diagnostic and therapeutic guidelines in MDS as<br />
provided by WP8, flow cytometric assessment is now recognized as one of the<br />
recommended approached in the diagnostic work-up (Leukemia, 2012; Leukemia &<br />
Lymphoma, <strong>2013</strong>)<br />
Studies: Prospective multicenter studies to emphasize diagnostics and prognostics in MDS<br />
were initiated.<br />
Registry: Another project is the successful registry for MDS (EUMDS) a collaboration<br />
between WP8 and Novartis. In total 1000 patients in 14 countries were registered, first<br />
results were presented at ASH 2011 and 2012 (de Witte et al.).<br />
Other topics:<br />
Collaborations with the MDS Foundation were initiated<br />
Finally, as can be depicted from the reference list below, the working group is successful in<br />
translating the workgroup conferences into published documents on behalf of ELN.<br />
1) Progress studies in EU‐MDS Registry<br />
General overview of EU‐MDS registry: Currently more than 1,457 patients have been<br />
<strong>report</strong>ed in the registry. Serbia and Croatia have joined the Registry and it will start <strong>report</strong>ing<br />
patients in a few months. Several manuscripts are in preparation, including the general<br />
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demographic paper which will include the impact of the new IPSS-R.<br />
2) <strong>The</strong> fifth international ELN workshop of FCM in MDS,Amsterdam, Netherlands<br />
October 26‐27, 2012<br />
3) Progress of the Trial Platform: EMSCO and planned trial(s)<br />
<strong>The</strong> ELN-based MDS clinical trial coordinating office (EMSCO) has been established in<br />
Dresden. <strong>The</strong> first trial in France and Germany is expected to start before the end of <strong>2013</strong>.<br />
4) ELN diagnostic and therapeutic guidelines and new plans, including specific guidelines for<br />
allogeneic SCT in MDS<br />
<strong>The</strong> manuscript has been submitted to Blood and it is under revision after having received<br />
the comments of the reviewers.<br />
2.1.9. WP9 (MPD):<br />
Projects:<br />
Clinically relevant end-points in contemporary trials for Ph-neg classical MPNs: A joint project<br />
of the ELN and IWG-MRT Groups<br />
<strong>The</strong> rationale of this project is that the selection of best variables for measuring benefits<br />
or harms of new interventions in Philadelphia negative classic MPNs is a complex and<br />
open to debate task. <strong>The</strong>re is a major need to develop clearly defined endpoints to<br />
support claims of efficacy of therapies for MPNs. <strong>The</strong>se endpoints need to be developed<br />
and utilized by investigators leading clinical trials in MPNs. <strong>The</strong> goal of this project is to<br />
provide guidance in the definition of clinically relevant end-points that can expedite new<br />
drug approvals for MPNs in the appropriate trial design settings.<br />
Registries:<br />
A new registry of patients with MPD and splanchnic vein thrombosis (Budd-Chiari syndrome,<br />
portal or mesenteric vein thrombosis) has been launched in <strong>2013</strong>.<br />
A new project was presented in <strong>2013</strong> and was opened in May <strong>2013</strong> to collect the cases of<br />
cerebral venous thrombosis in patients with MPD.<br />
<strong>The</strong> registry of pregnancies in patients with MPD was closed for inclusions in <strong>2013</strong>? And the<br />
analysis for a final <strong>report</strong> and publication is ongoing.<br />
A MPN&MPNr-EuroNet registry is in planning.<br />
Recommendations:<br />
Several recommendations have been released on behalf of the ELN, as described in the<br />
appendix 7.5.1.<br />
<strong>The</strong> leading project for recommendation in <strong>2013</strong> is the definition of resistance and<br />
intolerance to ruxolitinib.<br />
Another consensus conference is ongoing in <strong>2013</strong> to define and harmonize<br />
histomorphological response criteria to JAK inhibitors. Two face-to-face meetings have been<br />
organized and the redaction of the final consensus is in progress, with a publication planed<br />
for Q3 <strong>2013</strong>.<br />
2.1.10. WP10 (Diagnostics):<br />
WP10 aims at pursuing the exploration of the best methods for diagnosis and MRD detection<br />
in morphology and flow cytometry.<br />
<strong>The</strong> morphology faculty, driven by Pr Gina Zini, still works at implementing the atlas of bone<br />
marrow cells morphology, accessible on the ELN Website.<br />
In flow, recommendations about accreditation of the flow cytometry laboratory are in<br />
progress. Part of this will soon be in press in Cytometry Part B, as the result of an<br />
international workshop where WP10 members participated. Guidelines have been issued in<br />
France and discussed in Mannheim in February. <strong>The</strong> February <strong>2013</strong> annual meeting of the<br />
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group was organized jointly with WP9. A two days course of morphology and flow cytometry<br />
took place in Munich on March 15 and 16, <strong>2013</strong>.<br />
WP10 is recognized as a scientific working group of the <strong>European</strong> Hematology Association<br />
and organized its second session in Stockholm on June 13, <strong>2013</strong>.<br />
<strong>The</strong> working group has also agreed that flow cytometry (FC) adds significantly to MDS<br />
characterization, diagnosis and prognosis together with ELN WP8. It may also be useful in<br />
predicting and monitoring disease during treatment with new and standard therapeutic<br />
regimens. Repeated FC assessments are strongly recommended not only in cases such as<br />
ICUS and IDUS, but also to monitor the natural course of the disease in patients with<br />
untreated low and in<strong>term</strong>ediate-1 risk MDS. <strong>The</strong> same holds true for patients treated with<br />
currently available drugs, preferably within clinical trials as conducted by national and<br />
international collaborating groups.<br />
2.1.11. WP11 (cytogenetics):<br />
WP11 cooperates with other WPs on the following projects<br />
• comprehensive molecular profiling of T-ALL<br />
• whole-genome sequencing in CLL<br />
• new cytogenetic risk score in MDS<br />
• update of the leukemia gene atlas<br />
WP 11 had several quality management activities in 2012 (Round tests for FISH and<br />
chromosome banding).<br />
During the WP11 meeting results from several new studies conducted by WP11-members<br />
were introduced: A novel solely molecular prognostic scoring system for AML based on 1000<br />
pts. was presented by C. Haferlach. New data from an international study were shown<br />
proving that the monosomal karyotype is no independent prognostic marker but is closely<br />
associated with the complexity of cytogenetic changes (D. Haase). Interim results from a<br />
multicentric German registry-study of clinical features, treatment and prognosis in patients<br />
with Monosomy 7 (world-wide the largest data set) were presented b J. Schanz. A. Fabarius<br />
discussed the relevance of secondary cytogenetic changes in MDS based on a dataset of<br />
1,544 pts. from the German CML V-study. C. Ganster presented data from an international<br />
study (supported by the EUGESMA and the ELN Foundation) of MDS cases with<br />
der(1;7)(p10:q10) a rare abnormality in MDS and could prove that this anomaly has a much<br />
better prognosis as assumed before. H. Rieder and C. Haferlach presented important data of<br />
quality management in cytogenetics based on the evaluation of several round interlaboratory<br />
robin test of FISH- and chromosome banding analysis. C. Haferlach recommended several<br />
strategies to support the Atlas of Genetics and Cytogenetics in Oncology and Haematology<br />
which is an inalienable tool for every tumor cytogeneticist worldwide. Finally D. Haase<br />
enumerated future activities of WP 11 one of which will be the delineation of further rare<br />
abnormalities in MDS by international cooperations which was very successful for the<br />
der(1;7) project.<br />
2.1.12. WP12 (minimal residual disease):<br />
<strong>The</strong> minimal residual disease (MRD) working group (WP12) established assays from which<br />
patients with myeloid leukemias/myeloproliferative neoplasms (MPNs) can benefit from. <strong>The</strong><br />
key approach is the monitoring of minimal residual disease (MRD) using real-time<br />
quantitative PCR. In addition to standardization of assays (e.g. WT1 and NPM1 mutation in<br />
AML, and BCR-ABL and JAK2-V617F in MPNs), an important emphasis has been placed on<br />
standardizing all steps of MRD assessment, including development of a software package to<br />
allow consistent <strong>report</strong>ing of MRD results, improving communication between laboratories<br />
and clinicians, as well as facilitating comparison of results between laboratories (Østergaard<br />
et al, Leukemia 2011). Having established the optimal MRD assays, their clinical utility is<br />
now being evaluated in patients. In particular we have recently shown that the selected ELN<br />
JAK2-V617F assay can predict outcome in informative MPN patients following allogeneic<br />
transplant, allowing earlier intervention with donor lymphocyte infusion in case of impending<br />
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relapse, as compared to conventional post-transplant surveillance using chimerism assays<br />
(manuscript submitted). Moreover, quantitative PCR assays which were subject to intensive<br />
validation efforts during the ELN program have now been implemented into multicenter<br />
clinical trials e.g. conducted by the French ALFA, German AMLSG and UK NCRI<br />
collaborative groups in which they are used to guide treatment approach, including informing<br />
the application of allogeneic transplantation in first remission.<br />
2.1.13. WP13 (Next generation sequencing):<br />
WP13 was first interested in using gene expression profiling for investigating basic research<br />
topics and the application of microarrays in a clinical setting.<br />
However, since 2010 next generation sequencing is of much higher interest and takes over<br />
the focus. <strong>The</strong> evaluation of both screening methodologies is strongly supported by<br />
biostatisticians. Microarray data as well as more and more NGS data very recently were<br />
collected within the ELN network and involved respective subgroups in WP13 as well as<br />
other WPs in close collaborations. <strong>The</strong> DACH and the MILE studies are published and data<br />
is publicly available in the GEO database.<br />
WP13 cooperates with other WPs on the following projects:<br />
• comprehensive molecular profiling of T-ALL<br />
• whole-genome sequencing in CLL, CML<br />
• update of the leukemia gene atlas<br />
<strong>The</strong> IRON-II project is an ongoing major task of WP13. Next generation sequencing studies<br />
with the goal to harmonize diagnostics and procedures were performed and presented at<br />
several meetings including ASH 2012 (poster). <strong>The</strong> next meeting will be held in 7/<strong>2013</strong> in<br />
Munich to combine all efforts from more than 26 labs in europe and other countries (n=13) in<br />
6 disease related working groups.<br />
Many other new projects are established in close cooperation with FP-7: http://www.ngsptl.com/.<br />
This is the "NGS for Targeted Personalized <strong>The</strong>rapy of Leukemia" headed by G.<br />
Martinelli in Bologna.<br />
In addition, the WP13 will start in summer <strong>2013</strong> the IRON-III study to bring NGS to routine<br />
diagnostics in other laboratories based on shared SOPs and with bioinformatic support.<br />
2.1.14. WP14 (SCT):<br />
Main focus of the WP is the harmonization process especially between Europe and the US,<br />
providing valid information on changes in indications, frequencies among the different<br />
countries but also among diseases. WP14 makes use of synergies with the <strong>European</strong> Group<br />
for Blood and Marrow Transplantation (EBMT) and the Worldwide Network for Blood and<br />
Marrow Transplantation (WBMT). <strong>The</strong> main activities include regular surveys on the<br />
transplantation activity in Europe, recommendations for the use of stem cell transplantation<br />
assessment of key factors responsible for outcome and, as a current focus, the adaptation of<br />
transplantation conditions to the needs of elderly patients, mainly with AML and ALL.<br />
Studies:<br />
• HCT vs. CT in elderly AML.<br />
Recommendations:<br />
• Several recommendations on stem cell transplantation have been released on behalf<br />
of the ELN, as described in the appendix 7.5.1.<br />
• A consensus on the treatment of Graft-versus-Host-Disease was reached and<br />
published. Participants of WP14 participate to the ELN recommendations team for<br />
CML.<br />
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2.1.15. WP 15 (infectious diseases):<br />
WP15 initiated collaboration with IDSA regarding guidelines for vaccination of patients with<br />
hematological malignancies in general and after stem cell transplantation.<br />
WP15 will participate in the ECIL-5 conference in September.<br />
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2.2. Meeting and exchange activities<br />
12 meetings, symposia and workshops which reached 902 participants were directly<br />
financed by ESF. Additional educational meetings (n= 8) were performed with funding<br />
through unrestricted grants.<br />
4-5 yearly information booths (see appendix 7.2.1.), ELN, DGIM, ASH, EHA, and DKG-<br />
Kongress provided information on the ELN to interested visitors.<br />
• Annual Symposia (8 th to 10 th Annual Symposia of the <strong>European</strong> <strong>LeukemiaNet</strong>),<br />
annual ELN-meetings at EHA and ASH from 2011 to <strong>2013</strong>)<br />
• Scientific working meetings<br />
o<br />
4th and 5 th international ELN Workshop on Standardization of Flow Cytometry<br />
in MDS 2011 and 2012<br />
o EWALL Meeting Gravenbruch/Frankfurt 2011 and 2012<br />
o ELN WP10 “Diagnostics” Meeting Munich 2011<br />
o ELN Recommendation Meeting at ASH 2011 and 2012<br />
o AML Intergroup Reisensburg Symposium <strong>2013</strong>)<br />
o CML workshop (every year in the end of June in Mannheim, Germany<br />
• Educational meetings:<br />
o ELN Frontiers Meetings<br />
Vienna 2010<br />
Berlin 2011<br />
Istanbul 2012<br />
Prague <strong>2013</strong> (in planning) the meeting will take place in Prague)<br />
o Naples CML fellow days (educational workshop on chronic myeloid leukemia<br />
for young hematologists 2010-<strong>2013</strong><br />
• Spread of excellence by<br />
o multiple educational activities,<br />
o newsletters (RB 15, September 2010; RB 16, december 2011; RB 17,<br />
December 2012<br />
o 82 published manuscripts since 2010 (see appendix 7.5.4)<br />
o information booths at the annual congresses of the American Society of<br />
Hematology (ASH), the <strong>European</strong> Society of Hematology (EHA) and National<br />
Hematology Congresses, the Annual ELN Symposium, the annual ELN<br />
frontiers meeting, and the Naples Fellows day 2010 to <strong>2013</strong> (5 information<br />
booths per year).<br />
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2.3. Establishment of databases, registries, studies or similar<br />
infrastructures<br />
Trials on a <strong>European</strong> level were discussed, initiated and evaluated in international working<br />
groups (full list see appendix 7.3.1.). For a complete overview of <strong>European</strong> leukemia trials<br />
see also<br />
http://www.leukemia-net.org/content/leukemias/trial_registry/trial_registry/index_eng.html<br />
Properly designed and executed patient registries enhance clinical practice, patient<br />
outcomes, safety, and comparability between studies. <strong>The</strong> goal of <strong>European</strong> registries is to<br />
provide information and to facilitate the analysis and interpretation of data from leukemia<br />
clinical trials.<br />
<strong>The</strong> ELN fostered the initiation and continuation of the following <strong>European</strong> registries<br />
(complete list see appendix 7.3.2.):<br />
• EUTOS registry for CML patients<br />
• pregnancy registry for CML patients<br />
• MDS registry<br />
• APL registry<br />
• MPN registry<br />
ELN guidelines for different leukemia entities (in international cooperation) were compiled by<br />
international panels of experts. <strong>The</strong> most recent recommendations deal with stem cell<br />
transplantation, CML, flow cytometry, diagnostic standardization, response criteria for ET and<br />
PV; and on supportive care (see appendix 7.5.1.).<br />
2.4. Collaboration with other scientific networks, organizations and<br />
industry<br />
Partnerships of the ELN were enhanced, launched or renewed with<br />
• CML Patient Advocates Network<br />
• EHA (<strong>European</strong> Hematologic Association) Scientific working groups with<br />
WP5,6,7,8,12<br />
• EBMT (<strong>European</strong> Group for Blood and Marrow Transplantation) WP14<br />
• IACRLRD (International Association for Comparative Research on Leukemia and<br />
Related Diseases) WP4, WP5<br />
• Kompetenznetz “akute und chronische Leukämien“<br />
• HOVON WP4,5<br />
• SAKK WP4<br />
• GIMEMA WP4<br />
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3. <strong>European</strong> added value and ELN visibility<br />
<strong>The</strong> ELN will continue to set high standards for the investigation of all leukemias in Europe<br />
and qualify medical doctors and scientists with educational activities on treatment<br />
recommendations, new insights in the emergence of the disease and innovative research.<br />
<strong>The</strong> ELN brings together in a collaborative action across Europe<br />
113 leading national leukemia study groups (Fig. 1)<br />
109 interdisciplinary partner groups (diagnostics, treatment research, registry, guidelines)<br />
(more than 1000 physicians and scientists<br />
193 centers in 39 countries<br />
Major achievements include:<br />
• Cooperation to overcome fragmentation within the <strong>European</strong> leukemia research area<br />
• International cooperation with centers and scientists in US, Japan and Australia.<br />
• Accomplishment of a unique leukemia specific infrastructure given by the three<br />
network centers responsible for management (NMC), information (ELIC) and<br />
statistics/biometry (CICS) (WP1-3,17).<br />
• Clinical trials on a <strong>European</strong> scale through collaboration of the leading national<br />
leukemia trial groups on the different leukemia entities (WP4-9) and the<br />
interdisciplinary partner groups in diagnostics and therapy research (WP10-15)<br />
• Standardized protocols for clinical trials with uniform diagnostic procedures to achieve<br />
comparable data, resulting in better and equal treatment options across national<br />
borders<br />
• Networks of reference laboratories in leukemia diagnostics and pharmacogenetics<br />
across Europe (WP12, EUTOS for CML)<br />
• Management recommendations for all leukemias<br />
• Registries for information on current treatment and best treatment options (EUTOS<br />
for CML, EU-MDS, APL, CLL, MPN)<br />
• Improvement of patient care due to personalized treatment options<br />
• Spread of excellence (ELN Website and publications) and high level training and<br />
education to all physicians and researchers within leukemia research.<br />
<strong>The</strong> ELN is committed to sustain the collaborations within and outside the network and to<br />
further develop high quality standards in leukemia research, diagnosis and treatment.<br />
Global collaboration will strengthen the ELN Network within and outside Europe.<br />
<strong>The</strong> ELN is already collaborating with networks outside ESF countries. International<br />
collaborations are currently ongoing in the US, Uruguay, Australia, Canada, Israel, Japan,<br />
Korea and Russia.<br />
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4. ELN management and finances<br />
As agreed with ESF the funding of year 1 was not fully used in the first half of ESF funding in<br />
order to prolong the project until the beginning of 2015 and due to the fact that EU funding<br />
was available until 2010.<br />
All expenditures were justified by the SC (last meeting June <strong>2013</strong>, Stockholm at EHA).<br />
<strong>The</strong> following Table summarizes the funding and expenditures.<br />
Year Meeting Participants<br />
2011 ELN WP Meetings at 16 th Congress of EHA 105<br />
4th international ELN Workshop on Standardization of Flow Cytometry 71<br />
in MDS<br />
ELN WP10 Diagnostics Meeting 71<br />
EWALL Meeting Frankfurt 20<br />
2012 9th Annual Symposium of the ELN 446<br />
ELN WP Meetings at 17 th Congress of EHA 172<br />
5th international ELN Workshop on Standardization of Flow Cytometry 30<br />
in MDS<br />
EWALL Meeting Gravenbruch/Frankfurt 15<br />
ELN Recommendation Meeting at ASH Congress 27<br />
<strong>2013</strong> 10th Annual Symposium of the ELN 420<br />
Reisensburg Symposium AML Intergroup 51<br />
ELN WP Meetings at 18 th Congress of EHA 75<br />
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5. Publicity and publications: scientific quality and impact<br />
<strong>The</strong> ELN recommendations have major impact within the scientific community as shown here<br />
by two examples.<br />
1) <strong>The</strong> ELN management recommendations for CML are considered internationally<br />
influential by experts in the field. <strong>The</strong> first two editions have been cited by close to<br />
600 articles each. <strong>The</strong> 2009 edition in the JCO ranks on position 7 of the “top 50<br />
Most-cited JCO articles from 2009”. <strong>The</strong> update of the CML recommendations was<br />
revised by an international panel and is released in July <strong>2013</strong>. Since interest in these<br />
guidelines is high among hematologists and experts, they will be published as “pocket<br />
card” as the preceding editions. Pocket cards show the diagnosis and treatment<br />
synopsis in a comfortable pocket style format and can be ordered from the NMC.<br />
2) <strong>The</strong> ELN diagnosis and management recommendations for AML, published in 2010<br />
in Blood (Doehner et al.), have been successful with 383 citations overall (and nearly<br />
100 citations per year, respectively).<br />
6. Future planning, recommendations and conclusions<br />
<strong>The</strong> ELN is likely to have a durable impact on leukemia research in Europe. Infrastructure<br />
and the productive collaboration provided by the ELN have accomplished a valuable<br />
contribution to progress in the field of leukemia. <strong>The</strong> ELN will continue in the forefront of<br />
leukemia research, sharing activities with EHA through scientific groups, COST-, ESF<br />
Research Networking - and EU 7th framework programmes (e.g. the project “Next<br />
Generation Sequencing platform for targeted Personalized <strong>The</strong>rapy of Leukemia" headed by<br />
Prof. Martinelli, Bologna (http://www.ngs-ptl.com)), but also public- private partnerships and<br />
other research activities, challenging current knowledge and aiming for a cure of leukemias.<br />
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7. Appendices<br />
7.1. Appendix I - List of Steering Committee ELN – ELN/ESF<br />
Status* Title** Firstname Surname Gender Institute Universitá di Bologna- Unita Address<br />
Postal<br />
Code Town<br />
Country<br />
Complessa di Istituti di Cardiologia<br />
ELN Prof. Dr. Michele Baccarani M ed Ematologia Via Massarenti 9 40138 Bologna ITALY<br />
ELN Prof. Dr. Tiziano Barbui M<br />
ELN Prof. Dr. Marie C. Béné F Université Henri Poincare Nancy 1<br />
ELN Prof. Dr. Thomas Büchner M University of Münster<br />
ELN/ESF Dr. Daniel Coriu M<br />
ELN Prof. Dr. <strong>The</strong>o J.M. de Witte M<br />
Azienda Ospedaliera - Ospedali<br />
Riuniti di Bergamo Largo Barozzi 1 24128 Bergamo ITALY<br />
Fundeni Clinical Institute - University<br />
of Medicine and Pharmacy "Carol<br />
Davila"<br />
ELN Prof. Dr. Martin Dugas M University of Münster<br />
9 Avenue de la Foret<br />
Vandoevre les<br />
de Haye 54500 Nancy<br />
FRANCE<br />
Albert-Schweitzer-<br />
Campus 1 48129 Münster GERMANY<br />
258, Fundeni Street,<br />
sector 2 22328 Bucharest ROMANIA<br />
Stichting Katholieke Universiteit,<br />
University Medical Centre Nijmegen Geert Grooteplein 10 6500 HB Nijmegen<br />
THE<br />
NETHERLANDS<br />
Albert-Schweitzer-<br />
Campus 1 48149 Münster GERMANY<br />
ELN/ESF Prof. Dr. Günther Gastl M Innsbruck Medical University Anichstrasse 35 6020 Innsbruck AUSTRIA<br />
ELN Dr. Nicola Gökbuget F University of Frankfurt <strong>The</strong>odor-Stern-Kai 8th Floor, Guy's 7<br />
Frankfurt am<br />
60590 Main<br />
GERMANY<br />
Tower, St.<br />
ELN - ELN/ESF Dr. David Grimwade M King's College London<br />
Thomas`Street SE1 9RT London UNITED KINGDOM<br />
ELN Prof. Dr. Francois Guilhot M Université Universitätsmedizin de PoitiersGöttingen - 2, Rue de la Milétrie 86021 Poitiers cedex FRANCE<br />
Georg-August-Universität Göttingen - Robert-Koch-Straße<br />
ELN Prof. Dr. Detlef Haase M Stiftung Öffentlichen Rechts 40 37075 Göttingen GERMANY<br />
ELN Prof. Dr. Torsten Haferlach M<br />
ELN Prof. Dr. Joerg Hasford M<br />
MLL Münchner Leukämielabor<br />
GmbH<br />
ELN - ELN/ESF Prof. Dr. Rüdiger Hehlmann M III. Medizinische Universitätsklinik<br />
ELN/ESF Prof. Dr. Henrik Hjorth-Hansen M<br />
ELN Prof. Dr. Andreas Hochhaus M<br />
ELN Prof. Dr. Dieter Hoelzer M<br />
Max-Lebsche-Platz<br />
31 81377 München GERMANY<br />
Ludwig-Maximilians-University<br />
Munich Marchioninistr. 15 81377 Munich GERMANY<br />
Pettenkofer Straße<br />
22 68169 Mannheim GERMANY<br />
Norwegian University of Science and<br />
Technology Hogskoleringen 1 7491 Trondheim NORWAY<br />
Universitätsklinikum Jena, Klinik und<br />
Poliklinik für Innere Medizin II Erlanger Allee 101 7740 Jena GERMANY<br />
ONKOLOGIKUM Frankfurt am<br />
Frankfurt am<br />
Museumsufer Schaubstr. 16 60596 Main<br />
GERMANY<br />
ELN Prof. Dr. Per Ljungman M Karolinska Hospital and Institutet n.a. 14186 Stockholm SWEDEN<br />
ELN Prof. Dr. Emili Montserrat M<br />
Hospital Clinic Provincial de<br />
Barcelona Villarroel, 170 8036 Barcelona SPAIN<br />
ELN Prof. Dr. Dietger Niederwieser M Universität Leipzig Johannisallee 32A 4103 Leipzig GERMANY<br />
ELN - ELN/ESF Prof. Dr. G.J. Ossenkoppele M VU Academic Medical Center<br />
De Boelelaan 1117,<br />
Postbus 7057<br />
ELN/ESF Prof. Dr. Tapani Ruutu M Helsinki University Central Hospital Haartmaninkatu 4<br />
ELN Dr. Susanne Saußele F Universität<br />
ELN - ELN/ESF Prof. Dr. Bengt Simonsson M Uppsala Universitet<br />
1007 MB Amsterdam<br />
00029<br />
HUS Helsinki<br />
THE<br />
NETHERLANDS<br />
FINLAND<br />
Pettenkofer Straße<br />
22 68169 Mannheim GERMANY<br />
Sankt Olofsgatan<br />
10B 75185 Uppsala SWEDEN<br />
ELN/ESF Prof. Dr. André Tichelli M Kantonsspital Basel Petersgraben 4 4031 Basel SWITZERLAND<br />
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7.2. Appendix II - List of the supporting ESF Member Organisations<br />
Austrian Science Fund (FWF)<br />
<strong>The</strong> Czech Leukemia Study Group – for life (CZ-CELL)<br />
(withdraw support in 2012)<br />
Austria<br />
Czech Republic<br />
Haimaom Foundation (withdraw support in 2012)<br />
Academy of Finland, Research Council for Health<br />
Deutsche Forschungsgemeinschaft (DFG)<br />
Nederlandse Organisatie voor Wetenschappelijk Onderzoek<br />
(NWO)<br />
Research Council of Norway<br />
Consiliul National al Cercetarii Stiintifice din Invatamantul<br />
Superior (CNCSIS)<br />
Swedish Research Council (VR)<br />
Swiss National Science Foundation (SNSF)<br />
Medical Research Council (MRC)<br />
Finland<br />
Germany<br />
Netherlands<br />
Norway<br />
Romania<br />
Sweden<br />
Switzerland<br />
United Kingdom<br />
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7.3. Appendix III – ELN activities<br />
7.3.1. Meeting and exchange activities<br />
Year Meeting Participants<br />
2011 ELN WP Meetings at 16 th Congress of EHA 105<br />
4th international ELN Workshop on Standardization of Flow Cytometry 71<br />
in MDS<br />
ELN WP10 Diagnostics Meeting 71<br />
EWALL Meeting Frankfurt 20<br />
2012 9th Annual Symposium of the ELN 446<br />
ELN WP Meetings at 17 th Congress of EHA 172<br />
5th international ELN Workshop on Standardization of Flow Cytometry 30<br />
in MDS<br />
EWALL Meeting Gravenbruch/Frankfurt 15<br />
ELN Recommendation Meeting at ASH Congress 27<br />
<strong>2013</strong> 10th Annual Symposium of the ELN 420<br />
Reisensburg Symposium AML Intergroup 51<br />
ELN WP Meetings at 18 th Congress of EHA 75<br />
see also p. 15<br />
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7.3.2. Lectures<br />
Date City Title of the congress or symposia Title of the lecture Speaker<br />
09.04.2010 Kiew<br />
Workshop " Modern diagnostic and treatment<br />
approach to chronic myeloid leukemia"<br />
On the path to cure CML - New developments<br />
Prof. R. Hehlmann, ELN Coordinator<br />
09.04.2010 Kiew<br />
Workshop "Modern diagnostic and treatment Should first line imatinib treatment be optimized by combination<br />
Prof. R. Hehlmann, ELN Coordinator<br />
approach to CML"<br />
with IFN or by higher imatinib dose?<br />
12.04.2010 Genova International Meeting on CML Updated ELN recommendations for the management of CML Prof. R. Hehlmann, ELN Coordinator<br />
18.04.2010 Washington<br />
AACR - session on coordination of translational <strong>European</strong> <strong>LeukemiaNet</strong>,<br />
cancer research at the EU<br />
enabling personalized Leukemia diagnosis in Europe and beyond<br />
Prof. R. Hehlmann, ELN Coordinator<br />
24.04.2010 Warsaw Polish School of Hematology First and second line therapy of CML Prof. R. Hehlmann, ELN Coordinator<br />
08.05.2010 Split<br />
CML Symposium at Croatian Cooperative Group for <strong>European</strong> cooperation in leukemia research. Challenges and<br />
Heamtologycal disorders<br />
perspectives<br />
Prof. R. Hehlmann, ELN Coordinator<br />
17.05.2010 Naples <strong>European</strong> fellows educational day<br />
EUTOS for CML. An innovative collaboration between ELN and<br />
Novartis<br />
Prof. R. Hehlmann, ELN Coordinator<br />
17.05.2010 Naples<br />
<strong>The</strong> management of CML: current treatment<br />
Stem cell transplantation in CML treatment, and accelerated and<br />
paradigms and future perspectives. An educational<br />
blast phase management<br />
day for <strong>European</strong> fellows<br />
Dr. Susanne Saußele<br />
18.05.2010 Naples <strong>European</strong> fellows educational day <strong>The</strong> revised ELN recommendations Prof. R. Hehlmann, ELN Coordinator<br />
04.06.2010 Chicago ASCO<br />
Current best practices for management of accelerated / blast<br />
phase CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
01.10.2010 Venice Viruses, Genes and Cancer workshop Viral expression and pathogenesis Prof. R. Hehlmann, ELN Coordinator<br />
13.10.2010 Brussels<br />
<strong>European</strong> Cancer Patient Coalition (ECPC) Cancer <strong>The</strong> <strong>European</strong> <strong>LeukemiaNet</strong> Cooperative research to cure<br />
Summit: Making the Cancer Partnership work leukemia<br />
Prof. R. Hehlmann, ELN Coordinator<br />
20.10.2010 Vienna<br />
ELN Frontiers Meeting 2010 ‘New benchmarks in<br />
leukemia: Focus on CML, AML and MDS’<br />
Improving CML Management and the path to cure<br />
Prof. R. Hehlmann, ELN Coordinator<br />
23.10.2010 Vienna<br />
ELN Frontiers Meeting 2010 ‘New benchmarks in<br />
leukemia: Focus on CML, AML and MDS’<br />
<strong>The</strong> concept of cure and the path to cure<br />
Prof. R. Hehlmann, ELN Coordinator<br />
28.10.2010 Sinaia Society of Hematology, Romania<br />
Current options for first line treatment of CML and impact on<br />
prognosis<br />
Prof. R. Hehlmann, ELN Coordinator<br />
04.12.2010 Orlando CML Workshop How to optimize TKI treatment Dose? Schedule? Interferon? Prof. R. Hehlmann, ELN Coordinator<br />
07.12.2010 Mission Inn Fifth International Workshop in CML and MPN<br />
Treatment optimization in CML by tolerability adapted high dose<br />
imatinib<br />
Prof. R. Hehlmann, ELN Coordinator<br />
20.01.2011 Bologna<br />
Nuovi Traguardi nella Cura della Leucemia Mieloide<br />
Chronic myeloid leukemia - Once upon a time<br />
Cronica<br />
Prof. R. Hehlmann, ELN Coordinator<br />
26.03.2011 Warsaw Polish School of Hematology New first line approaches to a cure of CML Prof. R. Hehlmann, ELN Coordinator<br />
31.03.2011 Brüssel Hearing zur Clinical trial directive Clinical trials directive Prof. R. Hehlmann, ELN Coordinator<br />
03.05.2011 Wiesbaden<br />
117. Kongress der Deutschen Gesellschaft für<br />
Innere Medizin e.V.<br />
Neues in der <strong>The</strong>rapie der chronischen myeloischen Leukämien Dr. S. Saußele<br />
16.05.2011 Neapel <strong>European</strong> fellows educational day How to manage blast crisis Dr. Susanne Saußele<br />
16.05.2011 Neapel <strong>European</strong> fellows educational day<br />
Management of special CML populations: pregnant, paedriatric<br />
and elderly patients<br />
Dr. Susanne Saußele<br />
17.05.2011 Naples <strong>European</strong> fellows educational day Successes and perspectives of treatment optimization Prof. R. Hehlmann, ELN Coordinator<br />
17.05.2011 Naples <strong>European</strong> fellows educational day<br />
EUTOS for CML - the collaboration between ELN and Novartis<br />
continues<br />
Prof. R. Hehlmann, ELN Coordinator<br />
17.05.2011 Naples <strong>European</strong> fellows educational day<br />
Advanced methods and clinical application of disease monitoring:<br />
Prof. Dr. Martin Müller<br />
BCR-ABL quantification and mutation detection<br />
20.05.2011 St. Petersburg Symposium <strong>The</strong> goals of CML therapy Prof. R. Hehlmann, ELN Coordinator<br />
02.07.2011 Mannheim EUTOS-Meeting EURO-SKI Dr. S. Saußele<br />
02.07.2011 Mannheim EUTOS-Meeting Variant chromosomal aberrations Dr. S. Saußele<br />
09.09.2011 Berlin<br />
1st International Congress on Controversies in<br />
Stem Cell and Cellular <strong>The</strong>rapies (COSTEM)<br />
Allogenic SCT for CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
10.09.2011 Bonn<br />
Fortbildungsveranstaltung: Fortschritte in der<br />
<strong>The</strong>rapie Hämatologischer Neoplasien,<br />
Erstlinientherapie der CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
Universitätsklinikum Bonn<br />
12.09.2011 Kurashiki Invited speech at the University Approaching cure in chronic myeloid Leukemia Prof. R. Hehlmann, ELN Coordinator<br />
13.09.2011 Fukuoka Invited speech at the University New standards of care in CML Prof. R. Hehlmann, ELN Coordinator<br />
14.09.2011 Tsukuba Invited speech at the University Approaching cure in chronic myeloid Leukemia Prof. R. Hehlmann, ELN Coordinator<br />
15.09.2011 Tokyo XXV. Symposia of the IACRLRD Prognostic factors in CML Dr. S. Saußele<br />
16.09.2011 Tokyo<br />
XXV. Symposia of the IACRLRD, 50 years Jubilee<br />
lecture<br />
Approaching a cure in chronic myeloid Leukemia<br />
Prof. R. Hehlmann, ELN Coordinator<br />
19.09.2011 Dubrovnik<br />
“LEUKEMIA AND LYMPHOMA - East and West Are<br />
Together”<br />
Prognostic tools in CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
28.09.2011 Kiew Workshop "Perspectives of frontline <strong>The</strong>rapy" First-line treatment options for CML in 2011 Prof. R. Hehlmann, ELN Coordinator<br />
08.10.2011 Berlin ELN Frontiers Meeting Imatinib optimisation strategies – can we improve outcomes? Prof. R. Hehlmann, ELN Coordinator<br />
08.10.2011 Berlin ELN Frontiers Meeting Quality of life of patients with CML Dr. S. Saußele<br />
09.10.2011 Berlin ELN Frontiers Meeting New treatment approaches aiming at cure Prof. R. Hehlmann, ELN Coordinator<br />
14.10.2011 Bergamo<br />
Independent Clinical Research in Oncology, Revision of the Clinical Trials Directive 2001 – challenges and<br />
Fondazione Internazionale Menarini<br />
chances<br />
Prof. R. Hehlmann, ELN Coordinator<br />
14.10.2011 Bergamo<br />
Independent Clinical Research in Oncology,<br />
Fondazione Internazionale Menarini<br />
Chronic myeloid leukemia<br />
Prof. R. Hehlmann, ELN Coordinator<br />
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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Date City Title of the congress or symposia Title of the lecture Speaker<br />
28.10.2011<br />
Sofia National Congress of Hematology of the Bulgarian<br />
(Pravets) Society of Hematology<br />
First-line treatment options for CML in 2011<br />
Prof. R. Hehlmann, ELN Coordinator<br />
03.11.2011 New York<br />
6th International Congress on Myeloproliferative<br />
Diseases and Myelodysplastic Syndromes<br />
Update of management of advanced phase CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
12.12.2011 San Diego ASH CML <strong>The</strong> role of 2nd generation TKI Prof. R. Hehlmann, ELN Coordinator<br />
13.12.2011 La Jolla 6th Post-ASH International CML and MPN Workshop Prognostic prediction in CML Prof. R. Hehlmann, ELN Coordinator<br />
25.02.2012 Berlin 30. Deutscher Krebskongresses Aktuelle Prognosefaktoren und Erstlinien-<strong>The</strong>rapie bei CML Prof. Dr. M. Müller<br />
10.03.2012 Orlando Global Biomarkers Consortium Cancer biomarkers History and Overview Prof. R. Hehlmann, ELN Coordinator<br />
03.04.2012 Washington AACR Meeting<br />
Towards harmonised diagnosis and treatment options for<br />
leukemia subtypes in Europe and beyond (EUROPEAN<br />
LEUKEMIANET)<br />
Dr. S. Saußele<br />
20.04.2012 Warsaw Polish School of Haematology Rationale for the management of CML in 2012 Prof. R. Hehlmann, ELN Coordinator<br />
20.05.2012 Naples<br />
<strong>The</strong> management of CML: current treatment Stem cell transplantation in CML chronic, accelerated and blast<br />
paradigms and future perspectives. An educational phase management<br />
Dr. Susanne Saußele<br />
20.05.2012 Naples<br />
<strong>The</strong> management of CML: current treatment<br />
paradigms and future perspectives. An educational Quality of life in patients with CML<br />
Dr. Susanne Saußele<br />
day for <strong>European</strong> fellows<br />
20.05.2012 Naples <strong>European</strong> fellows educational day<br />
Advanced methods and clinical application of disease monitoring:<br />
Prof. Dr. Martin Müller<br />
BCR-ABL quantification and mutation detection<br />
20.05.2012 Naples <strong>European</strong> fellows educational day<br />
Cytogenetics and/or Molecular Response: What are the new<br />
standards of monitoring<br />
Prof. Dr. Martin Müller<br />
14.06.2012 Amsterdam EHA<br />
New EU Clinical Trials Directive: Revision 2012 - Measures taken by<br />
Prof. R. Hehlmann, ELN Coordinator<br />
the ELN to support clinical trials<br />
22.06.2012 Schwedt I. International Symposium in Oncology Schwedt Prevention of blast crisis Prof. R. Hehlmann, ELN Coordinator<br />
22.06.2012 Schwedt I. International Symposium in Oncology Schwedt CML-Mangament 2012 Prof. R. Hehlmann, ELN Coordinator<br />
29.06.2012 Mannheim CML-Studientreffen<br />
Follow up 2012 / Blastenkrise, 2nd generation TKI 2nd line / EURO-<br />
Dr. S. Saußele<br />
SKI Initiierung / QOL in der CML-Studie V (Tiger)<br />
03.07.2012 Moscow<br />
Annual Meeting of the Moscow Russian Society of Response prediction and treatment strategy with 2nd generation<br />
Prof. R. Hehlmann, ELN Coordinator<br />
Hematology<br />
TKI 2nd line<br />
04.07.2012 Moscow<br />
Annual Meeting of the Moscow Russian Society of<br />
Hematology<br />
Current best options for 1st line treatment of CP-CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
04.07.2012 Moscow<br />
Annual Meeting of the Moscow Russian Society of<br />
Hematology<br />
New frontline options of TKI treatment in CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
08.09.2012 Barcelona<br />
2nd World Congress on Controversies in<br />
Hematology (COHEM)<br />
Preferred first-line treatment of CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
14.09.2012 St. Petersburg CML-day at the Raisa Gorbatcheva conference 2012 Optimized imatinib Management of blast crisis Prof. R. Hehlmann, ELN Coordinator<br />
15.09.2012 St. Petersburg CML-day at the Raisa Gorbatcheva conference <strong>2013</strong> Management of blast crisis Prof. R. Hehlmann, ELN Coordinator<br />
15.09.2012 St. Petersburg CML-day at the Raisa Gorbatcheva conference <strong>2013</strong> CML blast crisis Dr. S. Saußele<br />
22.10.2012 Stuttgart<br />
Gemeinsame Jahrestagung der Deutschen,<br />
Österreichischen und Schweizerischen<br />
CML - TKI lebenslang oder absetzen!?<br />
Dr. S. Saußele<br />
Gesellschaften für Hämatologie und Onkologie<br />
27.10.2012 Venice Int. Workshop on “Viruses, Genes and Cancer “ From Abelson virus to targeted therapy of CML Prof. R. Hehlmann, ELN Coordinator<br />
11.11.2012 Istanbul ELN-Frontiers-Meeting TKI alone vs. other options Prof. R. Hehlmann, ELN Coordinator<br />
09.12.2012 Atlanta ASH<br />
Proposal of a Clinical Trial Regulation to replace Clinical Trial<br />
Directive 2001<br />
Prof. R. Hehlmann, ELN Coordinator<br />
14.03.<strong>2013</strong> Bejing<br />
Collaboration between Chinese hematologists and Cooperating with the <strong>European</strong> <strong>LeukemiaNet</strong> (Speech at the<br />
the <strong>European</strong> <strong>LeukemiaNet</strong><br />
Hematology Oncology Center of Beijing Children’s Hospital)<br />
Prof. R. Hehlmann, ELN Coordinator<br />
16.03.<strong>2013</strong> Seoul<br />
Asia CML Study Alliance (ACSA)-ELN Consensus<br />
meeting<br />
ELN-Recommendations <strong>2013</strong> and their impact on clinical practice Prof. R. Hehlmann, ELN Coordinator<br />
15.04.<strong>2013</strong> Bologna<br />
International Meeting on "New drugs in<br />
Hematology"<br />
CML - Status of the art of treatment<br />
Prof. R. Hehlmann, ELN Coordinator<br />
13.05.<strong>2013</strong> Naples <strong>European</strong> fellows educational day Current treatment paradigments Prof. R. Hehlmann, ELN Coordinator<br />
17.05.<strong>2013</strong> Novosibirsk II Eurasian Hematology Forum Biology of CML Prof. R. Hehlmann, ELN Coordinator<br />
17.05.<strong>2013</strong> Novosibirsk II Eurasian Hematology Forum Optimal treatment strategy for chronic myeloid leukemia today Prof. R. Hehlmann, ELN Coordinator<br />
21.05.<strong>2013</strong> Naples <strong>European</strong> fellows educational day Early prediction of prognosis by diagnostic and response markers Prof. R. Hehlmann, ELN Coordinator<br />
22.05.<strong>2013</strong> Naples <strong>European</strong> fellows educational day Prevention of blast crisis Prof. R. Hehlmann, ELN Coordinator<br />
All Russian Scientific Conference with International<br />
24.05.<strong>2013</strong><br />
Participation «Innovative Technologies in<br />
St. Petersburg<br />
Neuroendocrinology, Neuroscience and<br />
<strong>The</strong> modern concept of CML<br />
Prof. R. Hehlmann, ELN Coordinator<br />
Hematology», Almazov Centre<br />
Educational event “Managing and Integrating<br />
26.05.<strong>2013</strong> Hamburg<br />
Allogeneic Stem Cell Transplantation in the<br />
Biology and natural course of CML<br />
Management of Myeloproliferative Neoplasms” of<br />
Prof. R. Hehlmann, ELN Coordinator<br />
the CMWP<br />
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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.4. Appendix IV – <strong>European</strong> added value and ELN visibility<br />
7.4.1. New trials in the ELTR<br />
UKALL 14<br />
MARALL<br />
AMLSG 16-10<br />
EuroSKI<br />
HOMB 114242<br />
ARD12042<br />
BUM-5/GVH<br />
C AMN107 Y 2101<br />
JAKARTA<br />
HCT vs CT<br />
B1931022<br />
ARCADE<br />
ENESTFreedom<br />
EPIC<br />
RELIEF<br />
I3X-MC-JHTB<br />
JAKARTA2<br />
PIRON01<br />
OCEAN<br />
A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia<br />
Phase I/II study combining humanised anti-CD20 (veltuzumab), anti-CD22 (epratuzumab) or both<br />
monoclonal antibodies with chemotherapy in adults with recurrent B-precursor acute lymphoblastic leukaemia<br />
(ALL) – MARALL<br />
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic<br />
blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3<br />
internal tandem duplication<br />
Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic<br />
Syndrome and Secondary Disorders of Haematopoiesis<br />
Multicenter prospective trial estimating the persistence of molecular remission in chronic myeloid leukemia after<br />
stopping TKI<br />
An open-label, multi-center study investigating the safety and efficacy of Ofatumumab therapy versus physicians'<br />
choice in patients with bulky Fludarabine refractory chronic lymphocytic leukaemia (CLL)<br />
A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in<br />
Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to<br />
Hydroxyurea<br />
Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase<br />
on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic<br />
GvHD<br />
A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in<br />
Combination With Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Failed Prior<br />
<strong>The</strong>rapy With Other BCR-ABL Tyrosine-kinase Inhibitors<br />
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients<br />
with In<strong>term</strong>ediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential<br />
Thrombocythemia Myelofibrosis with Splenomegaly<br />
Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based<br />
Conditioning and HCT From Related and Unrelated Donors as Consolidation <strong>The</strong>rapy for Older Patients With<br />
AML in 1st Complete Remission<br />
An Open-Label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's<br />
Choice In Adult Patients With Relapsed Or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)<br />
A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of<br />
Anaemic Subjects With Low or In<strong>term</strong>ediate-1 Risk Myelodysplastic Syndrome (MDS)<br />
A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive<br />
Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease<br />
(MRD) Status on First Line Nilotinib Treatment<br />
A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed<br />
Chronic Myeloid Leukemia in Chronic Phase<br />
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter,<br />
Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes<br />
A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms<br />
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With<br />
Ruxolitinib and With a Current Diagnosis of In<strong>term</strong>ediate or High-Risk Primary Myelofibrosis, Post-Polycythemia<br />
Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis<br />
Iron overload in MDS patients: <strong>The</strong> value of new iron parameters and MRI T2* of heart and liver as predictor of<br />
iron overload<br />
A non-interventional observational post authorisation study to evaluate safety and efficacy in patients receiving<br />
azacitidine in daily clinical practice in the Netherlands<br />
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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.4.2. Registries<br />
Entity Title Start registry Website<br />
<strong>European</strong> Registries<br />
APL<br />
PROMYSE: A pan-<strong>European</strong> registry for relapsed Acute<br />
Promyelocytic Leukemia patients<br />
2009<br />
http://www.leukemianet.org/content/leukemias/aml/apl/apl_register/index_eng.html<br />
CLL<br />
International CLL registry for spontaneous regression in CLL of the<br />
<strong>European</strong> Research Initiative on CLL (ERIC)<br />
2011<br />
http://www.ericll.org/projects/registry_CLL_spontaneous_regressio<br />
n_delGiudice.php<br />
CLL<br />
<strong>European</strong> Online registry and support for Immunoglobulin gene<br />
sequence interpretation of ERIC<br />
http://www.ericll.org/projects/index.php<br />
CML <strong>European</strong> EUTOS for CML Register 2007 http://www.eutos.org/content/registry/index_eng.html<br />
Out-study (Patients diagnosed between 2002 and 2006 treated wih<br />
imatinib frontline and enrolled in prospective studies)<br />
In-study (Patients diagnosed between 2002 and 2006 treated wih<br />
imatinib frontline and already registed in national existing<br />
databases)<br />
Prospective poulation based (Newly diagnosed CVML patients with<br />
a specificed country/region irrespective of the treatment they<br />
recieved)<br />
MDS<br />
EUMDS: A Prospective, Multicenter <strong>European</strong> Registry for Newly<br />
Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low<br />
and In<strong>term</strong>ediate-1 Subtypes<br />
2008 http://www.eumds.org/<br />
MPN<br />
ERNEST: <strong>European</strong> Registry for Myeloproliferative Neoplasms<br />
towards a better understanding of Epidemiology, Survival and<br />
Treatment<br />
Patients with diagnosis of Ph- MPNs [ ET, PV, PMF, PPV-M, PET-MF];<br />
diagnosis according to 2008 WHO criteria. Diagnosis of MPN after<br />
2001.<br />
in planning<br />
ALL<br />
National Registries<br />
Biomaterial and prospective data collection for<br />
diagnosis, treatment and clinical course of ALL of the<br />
adults (German GMALL Register)<br />
2010<br />
AML German AML Register of the Study Alliance Leukemia (SAL) 2010 http://www.sal-aml.org/aml-register/einfuehrung<br />
CML<br />
German CML Register study (CML Study VI): Epidemiological study<br />
looking at the medical situation of CML patients<br />
<strong>2013</strong><br />
(will start<br />
soon)<br />
MDS German MDS Register Düsseldorf 1999 http://www.mds-register.de/<br />
MPN<br />
Trials<br />
German Register for rare myeloproliferative neoplasms<br />
diseases of mast cells 2010<br />
diseases of eosinophils 2009<br />
Osteomyelofibrosis 2012<br />
Trial registries<br />
<strong>European</strong> Leukemia Trial Registry of the <strong>European</strong> <strong>LeukemiaNet</strong><br />
http://www.leukemianet.org/content/leukemias/trial_registry/database/index_eng.html<br />
http://www.kompetenznetzleukaemie.de/trial/pdf/knl_en/shortprotocol_knl_LN_NN_2011_452.pdf<br />
?id=452<br />
Trials<br />
CLL trials registry for improvement in the long-<strong>term</strong> follow-up of CLL<br />
patients in <strong>European</strong> Trials: an ERIC Initiative<br />
upcoming<br />
http://www.ericll.org/pdf/slides/100610_barcelona/trials_registry_u<br />
pdt_hillmen.pdf<br />
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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.5. Appendix V – ELN management and finances<br />
Budget 2010<br />
Budget '10<br />
Budget '11<br />
Budget '11<br />
Budget '12<br />
Budget '12<br />
Budget '13<br />
Tentative '13<br />
Budget '14<br />
Tentative '14<br />
Budget '15<br />
Tentative '15<br />
Total Budget<br />
Budget Heading<br />
(revised<br />
proposal)<br />
issued<br />
(revised<br />
proposal)<br />
issued<br />
(proposal)<br />
issued<br />
(proposal)<br />
Budget<br />
(proposal)<br />
Budget<br />
(proposal)<br />
Budget<br />
for 5 years<br />
(May 2010 to<br />
(EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) (EUR) May 2015)<br />
Committee meetings 30.000 506 5.000 0 30.000 0 30.000 30.000<br />
<strong>Mid</strong>-<strong>term</strong> review (*) 0<br />
Science meetings: 35.000 0 35.000 35.000 35.000<br />
- Workshops 15.000 10.794 10.500 15.000 15.000 5.000 5.000<br />
- Conferences 20.000 20.000 80.000 61.500 55.000 60.000 33.000<br />
- School<br />
Grants:<br />
- Exchange visits 0 2000 0<br />
- Short visits<br />
Publication & dissemination 7.000 0 20.000 20.000 7.000 20.000 7.000 20.000 7.000 20.000 10.000 10.000<br />
External administrative costs 3.240 0 0 0 0 0<br />
Data base<br />
Coordination<br />
Miscellaneous<br />
Total of the proposal 75.240 62.000 72.000 72.000 72.000 353.240 €<br />
Total of the REAL plans * 506 50.794 110.500 96.500 90.000 48.000<br />
Expected annual budget<br />
for networking 84.218 84.218 79.293 74.368 74.368 396.463 €<br />
Unallocated funds (left over) 83.712 83.712 33.424 117.136 -31.208 85.928 -22.133 63.796 -15.633 48.163 -48.000 163,32<br />
ESF administrative costs (**) 14.283 14.283 19.208 24.133 24.133<br />
Total budget (incl **) 98.500 98.500 98.500 98.500 98.500 492.500<br />
(*) Chair's participation at the EMRC Standing Committee Plenary Meeting in order to present the mid-<strong>term</strong> <strong>report</strong><br />
(**) ESF administrative costs of 14.5% of requested contributions w ill be levied<br />
Estimated values<br />
* Funding since joining of the Netherlands not only 77 380€/year (as of 03.08.2010) but 84.220 € for networking<br />
24
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.6. Appendix VI – Publicity and publications: scientific quality and<br />
impact<br />
7.6.1. Recommendations and guidelines<br />
25
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
26
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.6.2. Public outreach founded by ESF<br />
Type of Activity Target group Description of activity<br />
RNP website<br />
broad scientific<br />
community<br />
Website of the <strong>European</strong> <strong>LeukemiaNet</strong> (Personnel, Hosting, Domain<br />
Fees)<br />
Circulation/distribution<br />
(Nbr of subscribers/<br />
prints etc.)<br />
na<br />
Monitored/<br />
maintained by<br />
<strong>European</strong><br />
Leukemia<br />
Information<br />
Center (ELIC)<br />
web/email address if<br />
applicable<br />
leukaemianet.eu,<br />
YES leukeaemia.eu<br />
mailing list<br />
RNP research<br />
community<br />
Design and printing Invitation and Programm of the ELN Symposia<br />
2012<br />
all registrated Network<br />
associates members of management<br />
the ELN<br />
center (NMC)<br />
YES<br />
newsletter<br />
broad scientific<br />
community Design and printing of the ElN information letter No. 8 and No. 9<br />
all registrated<br />
associates members of Network<br />
the ELN and anyone management<br />
online via website center (NMC)<br />
YES<br />
RNP website<br />
other<br />
RNP research<br />
community<br />
broad scientific<br />
community<br />
website of <strong>European</strong> Leukemia Trial Registry<br />
information booths at all important scientifc congresses in the field<br />
of hematology (EHA; ASH, DGHO) - not funded bythe ESF<br />
<strong>European</strong><br />
all registrated Leukemia<br />
associates members of Information<br />
the ELN<br />
Center (ELIC)<br />
participants of the<br />
congress<br />
Network<br />
management<br />
center (NMC)<br />
ESF acknowledged<br />
www.leukemiatrials.eu;<br />
www.studienregisteronline.de<br />
YES<br />
YES<br />
7.6.3. Public outreach not-founded by ESF<br />
Type of Activity Target group Description of activity<br />
Circulation/<br />
distribution<br />
(Nbr of<br />
subscribers/<br />
prints etc.) Monitored/ maintained by<br />
ESF acknowledged<br />
web/email address if applicable<br />
Newsletter of the ELN Hematologists Every year we <strong>report</strong>ed about the scientific news of the ELN<br />
Network management<br />
center (NMC)<br />
yes (since the<br />
funding of the ESF)<br />
New flyer about the ELN<br />
Hematologists<br />
Update of information about key activities of the ELN incl. an<br />
overview about the workpackages and a description how to join the<br />
ELN as well as contact details<br />
Network management<br />
center (NMC)<br />
no<br />
Newsletter of the ELN<br />
Foundation in different<br />
languages<br />
Physicians and patients;<br />
sponsors<br />
Information about the excellence of the ELN with the target to find<br />
sponsors<br />
Network management<br />
center (NMC)<br />
no<br />
ELN Foundation website<br />
Physicians and patients;<br />
sponsors<br />
Information about the excellence of the ELN with the target to find<br />
sponsors<br />
<strong>European</strong> Leukemia<br />
Information Center (ELIC) no<br />
http://www.elnfoundation.or<br />
g<br />
Flyer about the EUTOS for<br />
CML project Physicians and patients (CML) Information about the achievements 2007-2010<br />
Network management<br />
center (NMC)<br />
no<br />
EUTOS for CML website Physicians and patients (CML) Imformation about CML<br />
<strong>European</strong> Leukemia<br />
Information Center (ELIC) no<br />
http://www.eutos.org<br />
Pocket cards CML<br />
recommendations<br />
<strong>The</strong> ELN recommendations in compact form for physicians treating<br />
CML patients on a card in a size which can be put in the pocket of a<br />
Physicians treating CML patients doctors white coat<br />
Network management<br />
center (NMC)<br />
no<br />
Ballpoints<br />
New ELN booth<br />
Online Newsletter<br />
List of the ELN<br />
recommendations<br />
Physicians treating patients<br />
with leukemia; sponsors<br />
Visitors of hematological<br />
congresses<br />
all registered associated<br />
members of the ELN<br />
Physicians treating patients<br />
with leukemia<br />
Ballpoints with the contact information of the ELN or the ELN<br />
Foundation, "means of advertising" for the booth at scientific<br />
congresses and meetings<br />
Updating the information on the ELN booth with less but more<br />
targeted informations<br />
Every second months informations by E-Mail about new clinical trials,<br />
publications out of the ELN, and news of the ELN<br />
Print out of the List of the ELN treatment recommendations for the<br />
different entities of Leukemia published on the ELN Website,<br />
distribute on the ELN information booth at congresses and meetings<br />
Network management<br />
center (NMC)<br />
no<br />
Network management<br />
center (NMC)<br />
no<br />
no (but will be<br />
<strong>European</strong> Leukemia acknowledged in<br />
Information Center (ELIC) the future)<br />
Network management<br />
center (NMC)<br />
yes, on the<br />
website<br />
http://www.leukemianet.org/content/physicians/re<br />
commendations/index_eng.ht<br />
ml<br />
27
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.6.4 Scientific publications<br />
Author(s)<br />
Abdel-Wahab O, Pardanani A, Bernard OA,<br />
Finazzi G, Crispino JD, Gisslinger H, Kralovics<br />
R, Odenike O, Bhalla K, Gupta V, Barosi G,<br />
Gotlib J, Guglielmelli P, Kiladjian JJ, Noel P,<br />
Title<br />
Unraveling the genetic underpinnings of<br />
myeloproliferative neoplasms and<br />
understanding their effect on disease<br />
Type of<br />
Publication<br />
Cazzola M, Vannucchi AM, Hoffman R, Barbui course and response to therapy:<br />
T, Thiele J, Van Etten RA, Mughal T, Tefferi<br />
A.<br />
proceedings from the 6th International<br />
Post-ASH Symposium. article Am J Hematol.<br />
ECIL-3 classical diagnostic procedures for<br />
the diagnosis of invasive fungal diseases<br />
Bone Marrow<br />
Arendrup MC, Bille J, Dannaoui E, Ruhnke M, Heussel in patients CP, with Kibbler leukaemia. C<br />
article<br />
Transplant.<br />
Barbui T, Barosi G, Birgegard G, Cervantes F,<br />
Finazzi G, Griesshammer M, Harrison C,<br />
Hasselbalch HC, Hehlmann R, Hoffman R, Philadelphia-negative classical<br />
Kiladjian JJ, Kröger N, Mesa R, McMullin MF, myeloproliferative neoplasms: critical<br />
Pardanani A, Passamonti F, Vannucchi AM, concepts and management<br />
Reiter A, Silver RT, Verstovsek S, Tefferi A; recommendations from <strong>European</strong><br />
<strong>European</strong> <strong>LeukemiaNet</strong>.<br />
<strong>LeukemiaNet</strong>. article J Clin Oncol.<br />
If Other,<br />
specify In (journal title…) Volume, pages, year…<br />
Peer-reviewed<br />
ESF acknow-ledged<br />
Open Access (OA)<br />
If OA,<br />
enter<br />
web<br />
address<br />
Funde<br />
d by<br />
ELN<br />
Recomm Meeti<br />
endation ESF ng<br />
Pubme<br />
d<br />
recher<br />
che<br />
2012 May;87(5):562-8. doi:<br />
10.1002/ajh.23169. Epub 2012<br />
Mar 28.<br />
x<br />
2012 Aug;47(8):1030-45. doi:<br />
10.1038/bmt.2011.246. Epub<br />
2012 Jan 9. x x<br />
2011 Feb 20;29(6):761-70. doi:<br />
10.1200/JCO.2010.31.8436.<br />
Epub 2011 Jan 4. x x<br />
Barbui T, Thiele J, Passamonti F, Rumi E,<br />
Boveri E, Ruggeri M, Rodeghiero F, d'Amore Survival and disease progression in<br />
ES, Randi ML, Bertozzi I, Marino F, Vannucchi essential thrombocythemia are<br />
AM, Antonioli E, Carrai V, Gisslinger H,<br />
Buxhofer-Ausch V, Müllauer L, Carobbio A,<br />
Gianatti A, Gangat N, Hanson CA, Tefferi A.<br />
significantly influenced by accurate<br />
morphologic diagnosis: an international<br />
study. article J Clin Oncol.<br />
2011 Aug 10;29(23):3179-84.<br />
doi:<br />
10.1200/JCO.2010.34.5298.<br />
Epub 2011 Jul 11.<br />
x<br />
Barosi G, Birgegard G, Finazzi G,<br />
A unified definition of clinical resistance<br />
Griesshammer M, Harrison C, Hasselbalch H, and intolerance to hydroxycarbamide in<br />
Kiladijan JJ, Lengfelder E, Mesa R, Mc Mullin polycythaemia vera and primary<br />
MF, Passamonti F, Reilly JT, Vannucchi AM,<br />
Barbui T.<br />
myelofibrosis: results of a <strong>European</strong><br />
<strong>LeukemiaNet</strong> (ELN) consensus process. article Br J Haematol.<br />
Barosi G, Mesa R, Finazzi G, Harrison C,<br />
Kiladjian JJ, Lengfelder E, Mc Mullin MF,<br />
Passamonti F, Vannucchi AM, Besses C, Revised response criteria for<br />
Gisslinger H, Samuelsson J, Verstovsek S, polycythemia vera and essential<br />
Hoffman R, Pardanani A, Cervantes F, Tefferi thrombocythemia: a ELN and IWG-MRT<br />
A, Barbui T.<br />
consensus project. article Blood.<br />
Barosi G, Tefferi A, Barbui T; ad hoc<br />
committee ‘Definition of clinically relevant Do current response criteria in classical<br />
outcomes for contemporarily clinical trials in Ph-negative myeloproliferative<br />
Ph-neg MPNs’.<br />
neoplasms capture benefit for patients? article<br />
Leukemia.<br />
Béné MC, Nebe T, Bettelheim P, Buldini B,<br />
Bumbea H, Kern W, Lacombe F, Lemez P,<br />
Marinov I, Matutes E, Maynadié M,<br />
Oelschlagel U, Orfao A, Schabath R,<br />
Solenthaler M, Tschurtschenthaler G,<br />
Vladareanu AM, Zini G, Faure GC, Porwit A.<br />
Immunophenotyping of acute leukemia<br />
and lymphoproliferative disorders: a<br />
consensus proposal of the <strong>European</strong><br />
<strong>LeukemiaNet</strong> Work Package 10. review Leukemia.<br />
<strong>The</strong>rapeutic drug monitoring of imatinib<br />
Bouchet S, Titier K, Moore N, Lassalle R, in chronic myeloid leukemia:<br />
Ambrosino B, Poulette S, Schuld P, Belanger experience from 1216 patients at a<br />
C, Mahon FX, Molimard M.<br />
centralized laboratory.<br />
Buechner, Thomas; Schlenk, Richard F.;<br />
Schaich, Markus; et al.<br />
Carobbio, Alessandra; Finazzi, Guido;<br />
Antonioli, Elisabetta; et al.<br />
article<br />
Acute Myeloid Leukemia (AML):<br />
Different Treatment Strategies Versus a<br />
Common Standard Arm-Combined<br />
Prospective Analysis by the German<br />
AML Intergroup<br />
article<br />
Fundam Clin<br />
Pharmacol.<br />
Hydroxyurea in essential<br />
thrombocythemia: rate and clinical<br />
relevance of responses by <strong>European</strong><br />
<strong>LeukemiaNet</strong> criteria article BLOOD<br />
ECIL 3-2009 update guidelines for<br />
Castagna L, Bramanti S, Sarina B, Todisco E, Ibatici antifungal A, Santoro management. A.<br />
Castagnetti, Fausto; Testoni, Nicoletta;<br />
Luatti, Simona; et al.<br />
Deletions of the Derivative<br />
Chromosome 9 Do Not Influence the<br />
Response and the Outcome of Chronic<br />
Myeloid Leukemia in Early Chronic<br />
Phase Treated With Imatinib Mesylate:<br />
GIMEMA CML Working Party Analysis<br />
article<br />
article<br />
JOURNAL OF CLINICAL<br />
ONCOLOGY<br />
Bone Marrow<br />
Transplant.<br />
JOURNAL OF CLINICAL<br />
ONCOLOGY<br />
<strong>The</strong> <strong>European</strong> <strong>LeukemiaNet</strong> AML<br />
Cornelissen JJ, Gratwohl A, Schlenk RF,<br />
Sierra J, Bornhäuser M, Juliusson G, Råcil Z,<br />
Working Party consensus statement on<br />
allogeneic HSCT for patients with AML in<br />
Rowe JM, Russell N, Mohty M, Löwenberg B, remission: an integrated-risk adapted<br />
Socié G, Niederwieser D, Ossenkoppele GJ. approach. review Nat Rev Clin Oncol.<br />
Cross, N. C. P.; White, H. E.; Mueller, M. C.;<br />
et al.<br />
Della Porta et al.,<br />
2010 Mar;148(6):961-3. doi:<br />
10.1111/j.1365-<br />
2141.2009.08019.x. Epub 2009<br />
Nov 23. x x<br />
<strong>2013</strong> Apr 16. [Epub ahead of<br />
print] x x<br />
2012 May;26(5):1148-9. doi:<br />
10.1038/leu.2011.337. Epub<br />
2011 Nov 22. No abstract<br />
available.<br />
x<br />
2011 Apr;25(4):567-74. doi:<br />
10.1038/leu.2010.312. Epub<br />
2011 Jan 21. Review. x x<br />
2012 Oct 31. doi:<br />
10.1111/fcp.12007. [Epub<br />
ahead of print]<br />
Volume: 30 Issue: 29 Pages:<br />
3604-3610 DOI:<br />
10.1200/JCO.2012.42.2907<br />
Published: OCT 10 2012<br />
Volume: 116 Issue: 7 Pages:<br />
1051-1055 DOI:<br />
10.1182/blood-2010-03-<br />
272179 Published: AUG 19<br />
2010 x<br />
2012 Jun;47(6):866. doi:<br />
10.1038/bmt.2011.154. Epub<br />
2011 Aug 8. x x<br />
Volume: 28 Issue: 16 Pages:<br />
2748-2754 DOI:<br />
10.1200/JCO.2009.26.7963<br />
Published: JUN 1 2010<br />
2012 Oct;9(10):579-90. doi:<br />
10.1038/nrclinonc.2012.150.<br />
Epub 2012 Sep 4. Review. x x<br />
Volume: 26 Issue: 10 Pages:<br />
2172-2175 DOI:<br />
10.1038/leu.2012.104<br />
Published: OCT 2012 x x<br />
Standardized definitions of molecular<br />
response in chronic myeloid leukemia review LEUKEMIA<br />
Multicentre validation of a reproducible<br />
flow cytometric score for the diagnosis<br />
of low-risk myelodysplastic syndromes:<br />
results of a <strong>European</strong> LeukemiaNET<br />
study. article Haematologica.. 2012 Aug;97(8):1209-17 x<br />
x<br />
x<br />
x<br />
Deschler, Barbara; Ihorst, Gabriele;<br />
Platzbecker, Uwe; et al.<br />
Parameters detected by geriatric and<br />
quality of life assessment in 195 older<br />
patients with myelodysplastic<br />
syndromes and acute myeloid leukemia<br />
are highly predictive for outcome article HAEMATOLOGICA<br />
Volume: 98 Issue: 2 Pages:<br />
208-216 DOI:<br />
10.3324/haematol.2012.06789<br />
2 Published: FEB <strong>2013</strong> x<br />
28
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Author(s)<br />
Title<br />
Emanuel RM, Dueck AC, Geyer HL, Kiladjian<br />
JJ, Slot S, Zweegman S, te Boekhorst PA,<br />
Commandeur S, Schouten HC, Sackmann F,<br />
Kerguelen Fuentes A, Hernández-Maraver D,<br />
Pahl HL, Griesshammer M, Stegelmann F,<br />
Doehner K, Lehmann T, Bonatz K, Reiter A,<br />
Boyer F, Etienne G, Ianotto JC, Ranta D, Roy<br />
L, Cahn JY, Harrison CN, Radia D, Muxi P, Myeloproliferative neoplasm (MPN)<br />
Maldonado N, Besses C, Cervantes F, symptom assessment form total<br />
Johansson PL, Barbui T, Barosi G, Vannucchi symptom score: prospective<br />
AM, Passamonti F, Andreasson B, Ferrari ML,<br />
Rambaldi A, Samuelsson J, Birgegard G,<br />
Tefferi A, Mesa RA.<br />
Engelhard D, Mohty B, de la Camara R,<br />
Cordonnier C, Ljungman P.<br />
Fabarius, Alice; Leitner, Armin; Hochhaus,<br />
Andreas; et al.<br />
Faber, Edgar; Friedecky, David; Micova,<br />
Katerina; et al.<br />
Foa, Robin; Vitale, Antonella; Vignetti,<br />
Marco; et al.<br />
Giebel S, Thomas X, Hallbook H, Geissler K,<br />
Boiron JM, Huguet F, Koller E, Jaeger U,<br />
Smedmyr B, Hellmann A, Holowiecki J.<br />
Giehl, Michelle; Leitner, Armin; Haferlach,<br />
Claudia; et al.<br />
Gökbuget et al.,<br />
Gökbuget N, Hartog CM, Bassan R, Derigs HG,<br />
Dombret H, Greil R, Hernández-Rivas JM,<br />
Huguet F, In<strong>term</strong>esoli T, Jourdan E,<br />
Junghanss C, Leimer L, Moreno MJ, Reichle<br />
A, Ribera J, Schmid M, Serve H, Stelljes M,<br />
Stuhlmann R, Hoelzer D; German<br />
Multicenter Study Group for Adult ALL and<br />
the <strong>European</strong> Working Group for Adult ALL.<br />
Type of<br />
Publication<br />
international assessment of an<br />
abbreviated symptom burden scoring<br />
system among patients with MPNs. article J Clin Oncol.<br />
If Other,<br />
specify In (journal title…) Volume, pages, year…<br />
<strong>European</strong> guidelines for prevention and<br />
management of influenza in<br />
hematopoietic stem cell transplantation<br />
and leukemia patients: summary of ECIL-<br />
4 (2011), on behalf of ECIL, a joint<br />
venture of EBMT, EORTC, ICHS and ELN. article Transpl Infect Dis.<br />
Impact of additional cytogenetic<br />
aberrations at diagnosis on prognosis of<br />
CML: long-<strong>term</strong> observation of 1151<br />
patients from the randomized CML<br />
Study IV article BLOOD<br />
Imatinib trough plasma levels do not<br />
correlate with the response to therapy<br />
in patients with chronic myeloid<br />
leukemia in routine clinical setting<br />
article<br />
ANNALS OF<br />
HEMATOLOGY<br />
Dasatinib as first-line treatment for<br />
adult patients with Philadelphia<br />
chromosome-positive acute<br />
lymphoblastic leukemia article BLOOD<br />
<strong>The</strong> prophylactic use of granulocytecolony<br />
stimulating factor during<br />
remission induction is associated with<br />
increased leukaemia-free survival of<br />
adults with acute lymphoblastic<br />
leukaemia: a joint analysis of five<br />
randomised trials on behalf of the<br />
EWALL. article Eur J Cancer.<br />
Detection of centrosome aberrations in<br />
disease-unrelated cells from patients<br />
with tumor treated with tyrosine kinase<br />
EUROPEAN JOURNAL<br />
inhibitors<br />
article<br />
OF HAEMATOLOGY<br />
Recommendations of the <strong>European</strong><br />
Working Group for Adult ALL<br />
article<br />
Book, UNI-MED Verlag<br />
AG, 2011<br />
Liposomal cytarabine is effective and<br />
tolerable in the treatment of central<br />
nervous system relapse of acute<br />
lymphoblastic leukemia and very<br />
aggressive lymphoma. article Haematologica.<br />
International Working Group-<br />
Gotlib J, Pardanani A, Akin C, Reiter A,<br />
George T, Hermine O, Kluin-Nelemans H,<br />
Myeloproliferative Neoplasms Research<br />
and Treatment (IWG-MRT) &<br />
Hartmann K, Sperr WR, Brockow K, Schwartz <strong>European</strong> Competence Network on<br />
LB, Orfao A, Deangelo DJ, Arock M, Sotlar K, Mastocytosis (ECNM) consensus<br />
Horny HP, Metcalfe DD, Escribano L,<br />
Verstovsek S, Tefferi A, Valent P.<br />
response criteria in advanced systemic<br />
mastocytosis. article Blood.<br />
Grimwade, David<br />
<strong>The</strong> changing paradigm of prognostic<br />
factors in acute myeloid leukaemia<br />
article<br />
Refinement of cytogenetic classification<br />
in acute myeloid leukemia:<br />
de<strong>term</strong>ination of prognostic significance<br />
of rare recurring chromosomal<br />
abnormalities among 5876 younger<br />
Grimwade, David; Hills, Robert K.; Moorman, adult patients treated in the United<br />
Anthony V.; et al.<br />
Kingdom Medical Research Council trials article BLOOD<br />
Grimwade, David; Vyas, Paresh; Freeman,<br />
Sylvie<br />
Assessment of minimal residual disease<br />
in acute myeloid leukemia<br />
review<br />
BEST PRACTICE &<br />
RESEARCH CLINICAL<br />
HAEMATOLOGY<br />
CURRENT OPINION IN<br />
ONCOLOGY<br />
2012 Nov 20;30(33):4098-103.<br />
doi:<br />
10.1200/JCO.2012.42.3863.<br />
Epub 2012 Oct 15. Erratum in:<br />
J Clin Oncol. 2012 Dec<br />
20;30(36):4590. Ferarri, Maria<br />
L [corrected to Ferrari, Maria<br />
L].<br />
Peer-reviewed<br />
ESF acknow-ledged<br />
Open Access (OA)<br />
If OA,<br />
enter<br />
web<br />
address<br />
Funde<br />
d by<br />
ELN<br />
<strong>2013</strong> Jan 31. doi:<br />
10.1111/tid.12054. [Epub<br />
ahead of print]<br />
Volume: 118 Issue: 26<br />
Pages: 6760-6768 DOI:<br />
10.1182/blood-2011-08-<br />
373902 Published: DEC 22<br />
2011 x<br />
Volume: 91 Issue: 6 Pages:<br />
923-929 DOI: 10.1007/s00277-<br />
011-1394-x Published: JUN<br />
2012 x<br />
Volume: 118 Issue: 25<br />
Pages: 6521-6528 DOI:<br />
10.1182/blood-2011-05-<br />
351403 Published: DEC 15<br />
2011 x<br />
2012 Feb;48(3):360-7. doi:<br />
10.1016/j.ejca.2011.11.023.<br />
Epub 2011 Dec 22. (meeting<br />
war am 22.11.2012)<br />
Volume: 85 Issue: 2 Pages:<br />
139-148 DOI: 10.1111/j.1600-<br />
0609.2010.1459.x Published:<br />
AUG 2010<br />
x<br />
Recomm Meeti<br />
endation ESF ng<br />
x<br />
x<br />
x<br />
Pubme<br />
d<br />
recher<br />
che<br />
2011 Feb;96(2):238-44. doi:<br />
10.3324/haematol.2010.02809<br />
2. Epub 2010 Oct 15. x<br />
<strong>2013</strong> Mar 28;121(13):2393-401.<br />
doi: 10.1182/blood-2012-09-<br />
458521. Epub <strong>2013</strong> Jan 16. x<br />
Volume: 25 Issue: 4 Pages:<br />
419-425 DOI:<br />
10.1016/j.beha.2012.10.004<br />
Published: DEC 2012<br />
x<br />
Volume: 116 Issue: 3 Pages:<br />
354-365 DOI: 10.1182/blood-<br />
2009-11-254441 Published:<br />
JUL 22 2010<br />
x<br />
Volume: 22 Issue: 6 Pages:<br />
656-663 DOI:<br />
10.1097/CCO.0b013e32833ed<br />
831 Published: NOV 2010 x<br />
x<br />
Gröschel S, Schlenk RF, Engelmann J,<br />
Rockova V, Teleanu V, Kühn MW, Eiwen K,<br />
Erpelinck C, Havermans M, Lübbert M,<br />
Germing U, Schmidt-Wolf IG, Beverloo HB,<br />
Schuurhuis GJ, Ossenkoppele GJ,<br />
Schlegelberger B, Verdonck LF, Vellenga E,<br />
Verhoef G, Vandenberghe P, Pabst T,<br />
Bargetzi M, Krauter J, Ganser A, Valk PJ,<br />
Deregulated expression of EVI1 defines<br />
a poor prognostic subset of MLLrearranged<br />
acute myeloid leukemias: a<br />
study of the German-Austrian Acute<br />
Myeloid Leukemia Study Group and the<br />
Dutch-Belgian-Swiss HOVON/SAKK<br />
Löwenberg B, Döhner K, Döhner H, Delwel R. Cooperative Group. article J Clin Oncol.<br />
Frontline imatinib treatment of chronic<br />
myeloid leukemia: no impact of age on<br />
Gugliotta, Gabriele; Castagnetti, Fausto;<br />
Palandri, Francesca; et al.<br />
outcome, a survey by the GIMEMA CML<br />
Working Party article BLOOD<br />
Guilhot J, Baccarani M, Clark RE, Cervantes F,<br />
Guilhot F, Hochhaus A, Kulikov S, Mayer J, Definitions, methodological and<br />
Petzer AL, Rosti G, Rousselot P, Saglio G, statistical issues for phase 3 clinical<br />
Saussele S, Simonsson B, Steegmann JL, trials in chronic myeloid leukemia: a<br />
Zaritskey A, Hehlmann R.<br />
proposal by the <strong>European</strong> <strong>LeukemiaNet</strong>. article<br />
Blood.<br />
<strong>2013</strong> Jan 1;31(1):95-103. doi:<br />
10.1200/JCO.2011.41.5505.<br />
Epub 2012 Sep 24.<br />
Volume: 117 Issue: 21<br />
Pages: 5591-5599 DOI:<br />
10.1182/blood-2010-12-<br />
324228 Published: MAY 26<br />
2011 x<br />
2012 Jun 21;119(25):5963-71.<br />
doi: 10.1182/blood-2011-10-<br />
383711. Epub 2012 Apr 16. x x<br />
x<br />
29
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Author(s)<br />
Haferlach T, Kohlmann A, Wieczorek L, Basso<br />
G, Kronnie GT, Béné MC, De Vos J,<br />
Hernández JM, Hofmann WK, Mills KI, Gilkes<br />
A, Chiaretti S, Shurtleff SA, Kipps TJ,<br />
Rassenti LZ, Yeoh AE, Papenhausen PR, Liu<br />
WM, Williams PM, Foà R.<br />
Hanfstein, B.; Mueller, M. C.; Hehlmann, R.;<br />
et al.<br />
Title<br />
Type of<br />
Publication<br />
Clinical utility of microarray-based gene<br />
expression profiling in the diagnosis and<br />
subclassification of leukemia: <strong>report</strong><br />
from the International Microarray<br />
Innovations in Leukemia Study Group. article J Clin Oncol.<br />
Early molecular and cytogenetic<br />
response is predictive for long-<strong>term</strong><br />
progression-free and overall survival in<br />
chronic myeloid leukemia (CML) article LEUKEMIA<br />
If Other,<br />
specify In (journal title…) Volume, pages, year…<br />
Peer-reviewed<br />
ESF acknow-ledged<br />
Open Access (OA)<br />
If OA,<br />
enter<br />
web<br />
address<br />
Funde<br />
d by<br />
ELN<br />
Recomm Meeti<br />
endation ESF ng<br />
Pubme<br />
d<br />
recher<br />
che<br />
2010 May 20;28(15):2529-37.<br />
doi:<br />
10.1200/JCO.2009.23.4732.<br />
Epub 2010 Apr 20. x x<br />
Volume: 26 Issue: 9 Pages:<br />
2096-2102 DOI:<br />
10.1038/leu.2012.85<br />
Published: SEP 2012<br />
x<br />
Harrison et al<br />
Harrison, Christine J.; Hills, Robert K.;<br />
Moorman, Anthony V.; et al.<br />
JAK inhibition with ruxolitinib versus<br />
best available therapy for myelofibrosis. article N Engl J Med. 2012 Mar 1;366(9):787-98. x<br />
Cytogenetics of Childhood Acute<br />
Volume: 28 Issue: 16 Pages:<br />
Myeloid Leukemia: United Kingdom<br />
2674-2681 DOI:<br />
Medical Research Council Treatment<br />
JOURNAL OF CLINICAL 10.1200/JCO.2009.24.8997<br />
Trials AML 10 and 12<br />
article<br />
ONCOLOGY<br />
Published: JUN 1 2010<br />
x<br />
Hasford, Joerg; Baccarani, Michele;<br />
Hoffmann, Verena; et al.<br />
Hehlmann et al.<br />
Hehlmann, Ruediger; Lauseker, Michael;<br />
Jung-Munkwitz, Susanne; et al.<br />
Hengeveld M, Suciu S, Karrasch M, Specchia<br />
G, Marie JP, Muus P, Petti MC, Rotoli B,<br />
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al.<br />
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686-692 DOI: 10.1182/blood-<br />
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JOURNAL OF CLINICAL 10.1200/JCO.2010.32.0598<br />
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ONCOLOGY<br />
Published: APR 20 2011<br />
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compared with standard consolidation<br />
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with acute myeloid leukaemia aged<br />
between 46 and 60 years: final results of<br />
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CDKN2A/B Alterations Impair Prognosis<br />
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behalf of the GIMEMA Acute Leukemia<br />
Working Party<br />
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DEC 1 2011<br />
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HAEMATOLOGICA-THE 1683-1690 DOI:<br />
HEMATOLOGY<br />
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10.3324/haematol.2009.02079<br />
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HEMATOLOGIC<br />
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<strong>The</strong> Interlaboratory RObustness of Nextgeneration<br />
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INTERNATIONAL<br />
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Molecular markers in acute myeloid<br />
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30
<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
Author(s)<br />
Title<br />
Type of<br />
Publication<br />
If Other,<br />
specify In (journal title…) Volume, pages, year…<br />
Peer-reviewed<br />
ESF acknow-ledged<br />
Open Access (OA)<br />
If OA,<br />
enter<br />
web<br />
address<br />
Funde<br />
d by<br />
ELN<br />
Recomm Meeti<br />
endation ESF ng<br />
Pubme<br />
d<br />
recher<br />
che<br />
Lindqvist, Camilla A.; Christiansson, Lisa H.;<br />
Simonsson, Bengt; et al.<br />
Luatti, Simona; Castagnetti, Fausto;<br />
Marzocchi, Giulia; et al.<br />
T regulatory cells control T-cell<br />
proliferation partly by the release of<br />
soluble CD25 in patients with B-cell<br />
malignancies article IMMUNOLOGY<br />
Additional chromosomal abnormalities<br />
in Philadelphia-positive clone: adverse<br />
prognostic influence on frontline<br />
imatinib therapy: a GIMEMA Working<br />
Party on CML analysis article BLOOD<br />
Volume: 131 Issue: 3 Pages:<br />
371-376 DOI: 10.1111/j.1365-<br />
2567.2010.03308.x<br />
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761-767 DOI: 10.1182/blood-<br />
2011-10-384651 Published:<br />
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A multicenter phase II trial of decitabine<br />
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Luebbert, Michael; Rueter, Bjoern H.; Claus, with acute myeloid leukemia judged<br />
Rainer; et al.<br />
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Maertens J, Marchetti O, Herbrecht R, <strong>European</strong> guidelines for antifungal<br />
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Heinz WJ, Lass-Flörl C, Ribaud P, Thiebaut A, hematopoietic stem cell transplant<br />
Cordonnier C; Third <strong>European</strong> Conference recipients: summary of the ECIL 3--2009<br />
on Infections in Leukemia.<br />
update.<br />
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ECIL recommendations for the use of<br />
Marchetti O, Lamoth F, Mikulska M, Viscoli biological markers for the diagnosis of<br />
C, Verweij P, Bretagne S; <strong>European</strong> invasive fungal diseases in leukemic<br />
Conference on Infections in Leukemia (ECIL) patients and hematopoietic SCT<br />
Laboratory Working Groups.<br />
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HEMATOLOGY<br />
JOURNAL<br />
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1 Published: MAR 2012 x<br />
Bone Marrow<br />
Transplant.<br />
Bone Marrow<br />
Transplant.<br />
2011 May;46(5):709-18. doi:<br />
10.1038/bmt.2010.175. Epub<br />
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10.1038/bmt.2011.178. Epub<br />
2011 Sep 19. Review. x<br />
Marchioli R, Finazzi G, Specchia G, Cacciola R,<br />
Cavazzina R, Cilloni D, De Stefano V, Elli E,<br />
Iurlo A, Latagliata R, Lunghi F, Lunghi M,<br />
Marfisi RM, Musto P, Masciulli A, Musolino<br />
C, Cascavilla N, Quarta G, Randi ML, Rapezzi<br />
D, Ruggeri M, Rumi E, Scortechini AR, Santini<br />
S, Scarano M, Siragusa S, Spadea A, Tieghi A,<br />
Angelucci E, Visani G, Vannucchi AM, Barbui Cardiovascular events and intensity of<br />
T; CYTO-PV Collaborative Group.<br />
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Marzocchi, Giulia; Castagnetti, Fausto;<br />
Luatti, Simona; et al.<br />
Variant Philadelphia translocations:<br />
molecular-cytogenetic characterization<br />
and prognostic influence on frontline<br />
imatinib therapy, a GIMEMA Working<br />
Party on CML analysis article BLOOD<br />
<strong>2013</strong> Jan 3;368(1):22-33. doi:<br />
10.1056/NEJMoa1208500.<br />
Epub 2012 Dec 8.<br />
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10.1182/blood-2011-01-<br />
328294 Published: JUN 23<br />
2011 x<br />
x<br />
Matthes-Martin S, Feuchtinger T, Shaw PJ,<br />
Engelhard D, Hirsch HH, Cordonnier C,<br />
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Ljungman P; Fourth <strong>European</strong> Conference on leukemia and stem cell transplantation:<br />
Infections in Leukemia.<br />
summary of ECIL-4 (2011). article Transpl Infect Dis.<br />
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Michele Baccarani1, Michael W. Deininger2,<br />
Gianantonio Rosti3, Andreas Hochhaus4,<br />
Simona Soverini3, Jane F. Apperley5,<br />
Francisco Cervantes6, Richard E. Clark7,<br />
Jorge E. Cortes8, François Guilhot9, Henrik<br />
Hjorth-Hansen10, Timothy P. Hughes11,<br />
Hagop M. Kantarjian8, Dong-Wook Kim12,<br />
Richard A. Larson13, Jeffrey H. Lipton14,<br />
François-Xavier Mahon15, Giovanni<br />
Martinelli3, Jiri Mayer16, Martin C. Müller17,<br />
Dietger Niederwieser18, Fabrizio Pane19,<br />
Jerald P. Radich20, Philippe Rousselot21,<br />
Giuseppe Saglio22, Susanne Saussele17,<br />
Charles Schiffer23, Richard Silver24, Bengt<br />
EUROPEAN LEUKEMIANET<br />
RECOMMENDATIONS FOR THE<br />
Simonsson25, Juan-Luis Steegmann26, John MANAGEMENT OF CHRONIC MYELOID<br />
M. Goldman27, Rudiger Hehlmann17 LEUKEMIA. <strong>2013</strong>. article Blood submitted <strong>2013</strong> x<br />
Mijatovic, Vladan; Iacobucci, Ilaria; Sazzini, Imputation reliability on DNA biallelic<br />
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Conference on Infections in Leukemia<br />
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<strong>The</strong> use of mannan antigen and antimannan<br />
antibodies in the diagnosis of<br />
invasive candidiasis: recommendations<br />
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Infections in Leukemia. review Crit Care.<br />
Allogeneic stem cell transplantation for<br />
Nicolini, Franck Emmanuel; Basak, Grzegorz patients harboring T315I BCR-ABL<br />
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mutated leukemias article BLOOD<br />
Østergaard M, Nyvold CG, Jovanovic JV, Development of standardized<br />
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K, Pallisgaard N, Ozbek U, Pfeifer H, residual disease data using a <strong>report</strong>ing<br />
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D, Hokland P.<br />
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Eichhorst B, Hallek M, Döhner H, Hillmen P,<br />
van Oers M, Gribben J, Ghia P, Montserrat E, ERIC recommendations on TP53<br />
Stilgenbauer S, Zenz T; <strong>European</strong> Research mutation analysis in chronic lymphocytic<br />
Initiative on CLL (ERIC).<br />
leukemia. Review Leukemia.<br />
Rawstron AC, Böttcher S, Letestu R, Villamor Improving efficiency and sensitivity:<br />
N, Fazi C, Kartsios H, de Tute RM, Shingles J, <strong>European</strong> Research Initiative in CLL<br />
Ritgen M, Moreno C, Lin K, Pettitt AR, Kneba (ERIC) update on the international<br />
M, Montserrat E, Cymbalista F, Hallek M, harmonised approach for flow<br />
Hillmen P, Ghia P; <strong>European</strong> Research cytometric residual disease monitoring<br />
Initiative in CLL.<br />
in CLL. article Leukemia.<br />
2010;14(6):R222. doi:<br />
10.1186/cc9365. Epub 2010<br />
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10.1182/blood-2011-07-<br />
367326 Published: NOV 17<br />
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2011 Jul;25(7):1168-73. doi:<br />
10.1038/leu.2011.69. Epub<br />
2011 Apr 15. x x x<br />
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10.1038/leu.2012.25. Epub<br />
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Title<br />
Rego EM, Kim HT, Ruiz-Argüelles GJ,<br />
Undurraga MS, Uriarte Mdel R, Jacomo RH,<br />
Gutiérrez-Aguirre H, Melo RA, Bittencourt R,<br />
Pasquini R, Pagnano K, Fagundes EM,<br />
Chauffaille Mde L, Chiattone CS, Martinez L,<br />
Meillón LA, Gómez-Almaguer D, Kwaan HC,<br />
Garcés-Eisele J, Gallagher R, Niemeyer CM, Improving acute promyelocytic<br />
Schrier SL, Tallman M, Grimwade D, Ganser leukemia (APL) outcome in developing<br />
A, Berliner N, Ribeiro RC, Lo-Coco F, countries through networking, results of<br />
Löwenberg B, Sanz MA.<br />
Simonsson, Bengt; Gedde-Dahl, Tobias;<br />
Markevarn, Berit; et al.<br />
Skiada A, Lanternier F, Groll AH, Pagano L,<br />
Zimmerli S, Herbrecht R, Lortholary O,<br />
Petrikkos GL; <strong>European</strong> Conference on<br />
Infections in Leukemia.<br />
Type of<br />
Publication<br />
the International Consortium on APL. article Blood.<br />
Combination of pegylated IFN-alpha 2b<br />
with imatinib increases molecular<br />
response rates in patients with low- or<br />
in<strong>term</strong>ediate-risk chronic myeloid<br />
leukemia article BLOOD<br />
Diagnosis and treatment of<br />
mucormycosis in patients with<br />
hematological malignancies: guidelines<br />
from the 3rd <strong>European</strong> Conference on<br />
Infections in Leukemia (ECIL 3). article Haematologica.<br />
If Other,<br />
specify In (journal title…) Volume, pages, year…<br />
Smith, Matthew L.; Hills, Robert K.;<br />
Grimwade, David<br />
Independent prognostic variables in<br />
acute myeloid leukaemia review BLOOD REVIEWS<br />
BCR-ABL kinase domain mutation<br />
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Soverini S, Hochhaus A, Nicolini FE, Gruber patients treated with tyrosine kinase<br />
F, Lange T, Saglio G, Pane F, Müller MC, Ernst inhibitors: recommendations from an<br />
T, Rosti G, Porkka K, Baccarani M, Cross NC, expert panel on behalf of <strong>European</strong><br />
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Soverini, Simona; Rosti, Gianantonio;<br />
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Soverini, Simona; Vitale, Antonella; Poerio,<br />
Angela; et al.<br />
Te Raa GD, Malcikova J, Pospisilova S,<br />
Trbusek M, Mraz M, Le Garff-Tavernier M,<br />
Merle-Béral H, Lin K, Pettitt AR, Merkel O,<br />
Stankovic T, van Oers MH, Eldering E,<br />
Stilgenbauer S, Zenz T, Kater AP; on behalf<br />
of the <strong>European</strong> Research Initiative on CLL<br />
(ERIC).<br />
Choosing the Best Second-Line Tyrosine<br />
Kinase Inhibitor in Imatinib-Resistant<br />
Chronic Myeloid Leukemia Patients<br />
Harboring Bcr-Abl Kinase Domain<br />
Mutations: How Reliable Is the IC50? article ONCOLOGIST<br />
Philadelphia-positive acute<br />
lymphoblastic leukemia patients<br />
already harbor BCR-ABL kinase domain<br />
mutations at low levels at the time of<br />
diagnosis<br />
article<br />
Overview of available p53 function tests<br />
in relation to TP53 and ATM gene<br />
alterations and chemoresistance in<br />
chronic lymphocytic leukemia. article Leuk Lymphoma.<br />
van de Loosdrecht AA, Ireland R, Kern W,<br />
Della Porta MG, Alhan C, Balleisen JS,<br />
Bettelheim P, Bowen DT, Burbury K,<br />
Eidenschink L, Cazzola M, Chu SS, Cullen M,<br />
Cutler JA, Dräger AM, Feuillard J, Fenaux P,<br />
Font P, Germing U, Haase D, Hellström-<br />
Lindberg E, Johansson U, Kordasti S, Loken<br />
MR, Malcovati L, te Marvelde JG, Matarraz S,<br />
Milne T, Moshaver B, Mufti GJ, Nikolova V,<br />
Ogata K, Oelschlaegel U, Orfao A,<br />
Ossenkoppele GJ, Porwit A, Platzbecker U,<br />
Preijers F, Psarra K, Richards SJ, Subirá D,<br />
Seymour JF, Tindell V, Vallespi T, Valent P,<br />
Rationale for the clinical application of<br />
flow cytometry in patients with<br />
myelodysplastic syndromes: position<br />
paper of an International Consortium<br />
van der Velden VH, Wells DA, de Witte TM, and the <strong>European</strong> <strong>LeukemiaNet</strong> Working<br />
Zettl F, Béné MC, Westers TM.<br />
Group. article Leuk Lymphoma.<br />
c-Myb and its target Bmi1 are required<br />
Waldron, T.; De Dominici, M.; Soliera, A. R.; for p190BCR/ABL leukemogenesis in<br />
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Westers TM, Ireland R, Kern W, Alhan C,<br />
Balleisen JS, Bettelheim P, Burbury K, Cullen<br />
M, Cutler JA, Della Porta MG, Dräger AM,<br />
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Establishment and Validation of<br />
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Standardization of Quantitative BCR-<br />
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Benner A, Soussi T, Helfrich H, Heuberger M,<br />
Hoth P, Fuge M, Denzel T, Häbe S, Malcikova<br />
J, Kuglik P, Truong S, Patten N, Wu L, Oscier<br />
D, Ibbotson R, Gardiner A, Tracy I, Lin K,<br />
Pettitt A, Pospisilova S, Mayer J, Hallek M,<br />
Döhner H, Stilgenbauer S; <strong>European</strong><br />
Research Initiative on CLL (ERIC).<br />
Peer-reviewed<br />
ESF acknow-ledged<br />
Open Access (OA)<br />
If OA,<br />
enter<br />
web<br />
address<br />
Funde<br />
d by<br />
ELN<br />
Recomm Meeti<br />
endation ESF ng<br />
Pubme<br />
d<br />
recher<br />
che<br />
<strong>2013</strong> Mar 14;121(11):1935-43.<br />
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