Status:
TERMINATED
Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Burkitt Lymphoma
Eligibility:
All Genders
6-20 years
Phase:
PHASE2
Brief Summary
This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the response rate of Ritu...
Detailed Description
This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the response rate of Ritu...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven B-cell malignancies, either Burkitt NHL or L3 ALL or large B-cell lymphoma or aggressive B-cell NHL, with the exception of diffuse large B-cell lymphoma arising in the mediastinum.
- Immunohistochemistry showing CD20 positivity
- Measurable (at least one bi-dimensionally measurable lesion) or evaluable (bone marrow, bone involvement) disease in progression since the last evaluation
- First relapsed or refractory disease after LMB or BFM protocol, except the isolated CNS relapses
- Life expectancy \> 4 weeks
- Performance status (Karnofsky) \> 30
- Adequate hepatic, renal and cardiac functions
- Wash out of 3 weeks in case of recent chemotherapy
- Complete initial work-up within 8 days prior to treatment
- Able to comply with scheduled follow-up and with management of toxicity
- Written inform consent form from adult patients and from parents and legal guardians for minor children
Exclusion
- Active viral infection, especially chronic hepatitis B
- previous salvage therapy for relapse
- Prior or current history of severe allergy
- Primary large B-cell lymphoma of the mediastinum
- Isolated CNS relapse
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00180895
Start Date
June 1 2004
Last Update
September 11 2006
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800