Overview

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