Trials / Completed
CompletedNCT01516580
Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients
Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 482 (actual)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH \> Nx2, any stage IV or B-AL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C | Prephase (COP) for all groups followed by: in group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m² in group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses. |
| DRUG | Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C | LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE). |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2017-06-13
- Completion
- 2022-11-16
- First posted
- 2012-01-25
- Last updated
- 2026-02-09
Locations
10 sites across 10 countries: Belgium, Canada, China, France, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01516580. Inclusion in this directory is not an endorsement.