Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3 acute leukemia, large B-cell lymphoma and non subclassified aggressive B-cell NHL

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborator: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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