Treatment of Mature B-cell Lymphoma/Leukaemia

Completed · Phase 3

Conditions studied: B-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00162656

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

848

Starts

1996-05-01

Expected to finish

2011-05-01

Last updated by the study team

2012-03-28

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow > 5% L3 blasts.
• Pre treatment imaging studies adequate to document Murphy disease stage
• Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)
• Patients should be available for a minimum follow up of 36 months
• Informed consent prior to study entry

You may not qualify if…

• Anaplastic large cell Ki 1 positive lymphomas
• Previous chemotherapy.
• Congenital immunodeficiency
• Prior organ transplantation
• Previous malignancy of any type
• Known HIV positivity

Where it is running

• Morgan Stanley Childrens Hospital of New York Presbyterian — New York, New York, United States
• Institut Gustave Roussy — Villejuif, France
• Sheffield Children's Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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