Autologous Bone Marrow Transplantation - Blog Science Connections

International NHL Trial 339
cannot be administered, the patient will still be followed up as scheduled until
the end of the study.
All investigators will be able to connect their own personal computers to
the coordinating center's computer by data process networks and TRANSPAC
(in France). This computer provides a 24-hour service for allocation,
interactive checking of all eligibility criteria, and confirmation of this
allocation.
Follow-up
Because of the different treatment procedures in the two groups, followup
of patients will vary between them during the treatment phase. However,
assessment of the main end points will be done monthly in both groups and at
the same fixed times.
ASSESSMENT OF END POINTS
The main end point is a binary criterion based on the evidence of an event
(failure) or its absence (success). This event must be a hard end point,
defined as evidence of a relapse (if CR was achieved); evidence of progression
(if patient achieved only PR); appearance of a new tumor in a new locale; or
death, whatever the cause, if observed before relapse or progression.
Secondary end points concern death or toxicity. Records of deaths are
necessary for computing the survival rate in the different treatment groups. A
death could be early, related to toxicity, accidental, or disease related.
Toxicity may be monitored on three levels: toxic deaths, major toxicities, and
minor toxicities. Regular evaluations must be scheduled in the protocol
before and after each treatment, at preinclusion, after two DHAP courses,
after irradiation, and after chemotherapy. Relapse, failure, or death require
specific evaluations.
SAMPLE SIZE AND STATISTICAL CONSIDERATIONS
Sample size computations for this trial must be based on the following
two assumptions: First, the 2-year success rate in the conventional arm is
estimated at 1556 (i.e., event-free rate) (see above). In the ABMT arm, the
success rate is expected to be 3556 (improvement, 2056). Statistical errors are
or = .05 and B =.20 (power = .80). Comparisons will be performed with
two-sided tests. Thus, the number of patients under these specifications will
be 71 patients per arm, that is to say, 142 patients to be randomized. The
response rate to conventional therapy after two courses is estimated at
approximately 5056. Therefore, 300 patients have to be screened in the
preinclusion phase. Finally, based on an inclusion rate of 45 patients per
year, the time necessary to complete trial recruitment will be 3 years.