Status:
COMPLETED
Treatment of Mature B-cell Lymphoma/Leukaemia
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
B-Cell Lymphoma
Eligibility:
All Genders
6-20 years
Phase:
PHASE3
Brief Summary
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 lympho...
Detailed Description
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. Ra...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Anaplastic large cell Ki 1 positive lymphomas
- Previous chemotherapy.
- Congenital immunodeficiency
- Prior organ transplantation
- Previous malignancy of any type
- Known HIV positivity
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
848 Patients enrolled
Trial Details
Trial ID
NCT00162656
Start Date
May 1 1996
End Date
May 1 2011
Last Update
March 28 2012
Active Locations (3)
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1
Morgan Stanley Childrens Hospital of New York Presbyterian
New York, New York, United States
2
Institut Gustave Roussy
Villejuif, France, 94800
3
Sheffield Children's Hospital
Sheffield, United Kingdom