Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89
therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both
reduction and deletion. Randomization occurs following COPADM1 and is stratified for
national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII;
Murphy III+LDH<2N; Murphy III+LDH>2N or Murphy IV).
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller
long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus
reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs
following COPADM2 and is stratified for national group, histology (large cell; small non
cleaved cell) and CNS disease.
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance
courses result in a smaller long-term EFS than standard LMB 89 treatment C
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
3 years
No
Catherine Patte, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
FAB LMB96
NCT00162656
May 1996
May 2011
Name | Location |
---|---|
Morgan Stanley Childrens Hospital of New York Presbyterian | New York, New York |