Clinical trial · Interventional
Treatment of Mature B-cell Lymphoma/Leukaemia
Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
- 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 an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
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 |
|---|---|---|---|
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| half cyclophosphamide | Drug | — | UNRESOLVED |
| LMB B | Drug | — | UNRESOLVED |
| LMB C | Drug | — | UNRESOLVED |
| mini CYVE, without 3 maintenance courses | Drug | — | UNRESOLVED |
| without COPADM3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- Standard LMB B
- interventionNames
- Drug: LMB B
- type
- EXPERIMENTAL
- label
- LMB B without COPADM3
- interventionNames
- Drug: without COPADM3
- type
- EXPERIMENTAL
- label
- LMB B with half cyclophosphamide
- interventionNames
- Drug: half cyclophosphamide
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow \> 5% L3 blasts. * Pre treatment imaging studies adequate to document Murphy disease stage * Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts) * Patients should be available for a minimum follow up of 36 months * Informed consent prior to study entry Exclusion Criteria: * Anaplastic large cell Ki 1 positive lymphomas * Previous chemotherapy. * Congenital immunodeficiency * Prior organ transplantation * Previous malignancy of any type * Known HIV positivity
References
Publications (1)
- DERIVEDFrazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available. PMID 30117142