Clinical trial · Interventional
Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL
A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL
NCT00180895CI-TRIAL-00000436terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of patients achieving at least objective response after 2 courses of rituximab
Secondary outcomes (4)
- measure
- Rate of objective response after 4 courses of rituximab
- measure
- Rate of initially responding patients who progressed during the second phase of treatment
- measure
- Toxicity
- measure
- Pharmacokinetic evaluation in serum and CSF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.