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Sponsored by: |
Institut Gustave Roussy |
Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00162656 |
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
Condition | Intervention | Phase |
B-Cell Lymphoma |
Drug: cyclophosphamide Drug: COPADM3 Drug: CYVE, 3 maintenance courses |
Phase III |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
ChemIDplus related topics: | Cyclophosphamide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Mature B-Cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study |
Estimated Enrollment: | 800 |
Study Start Date: | May 1996 |
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
Ages Eligible for Study: | 6 Months to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |||||
Morgan Stanley Childrens Hospital of New York Presbyterian | |||||
New York, New York, United States | |||||
France | |||||
Institut Gustave Roussy | |||||
Villejuif, France, 94800 | |||||
United Kingdom | |||||
Sheffield Children’s Hospital | |||||
Sheffield, United Kingdom |
Institut Gustave Roussy |
Principal Investigator: | Catherine Patte, MD | Institut Gustave Roussy |
Principal Investigator: | Mitchell S Cairo, MD | Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia University |
Principal Investigator: | Mary Gerrard, MD | Sheffield Children’s Hospital |
Study ID Numbers: | FAB LMB96 |
First Received: | September 7, 2005 |
Last Updated: | September 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00162656 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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