Treatment of Mature B-cell Lymphoma/Leukaemia
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
B-Cell Lymphoma |
Drug: half cyclophosphamide Drug: without COPADM3 Drug: mini CYVE, without 3 maintenance courses Drug: LMB B Drug: LMB C |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study |
- Event free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
- Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- long term toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]long term toxicity: cardiotoxicity, impaired fertility, secondary malignancy
| Enrollment: | 848 |
| Study Start Date: | May 1996 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Standard LMB B | Drug: LMB B |
| Experimental: LMB B without COPADM3 | Drug: without COPADM3 |
| Experimental: LMB B with half cyclophosphamide | Drug: half cyclophosphamide |
| Experimental: LMB B without COPADM3 and with half cyclophosphamide | Drug: half cyclophosphamide Drug: without COPADM3 |
| Active Comparator: LMB C standard | Drug: LMB C |
| Experimental: LMB C with mini CYVE and without 3 maintenance courses | Drug: mini CYVE, without 3 maintenance courses |
Detailed Description:
Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH<2N; Murphy III+LDH>2N or Murphy IV).
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
Eligibility| Ages Eligible for Study: | 6 Months to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Morgan Stanley Childrens Hospital of New York Presbyterian | |
| New York, New York, United States | |
| France | |
| Institut Gustave Roussy | |
| Villejuif, France, 94800 | |
| United Kingdom | |
| Sheffield Children's Hospital | |
| Sheffield, United Kingdom | |
| Principal Investigator: | Catherine Patte, MD | Institut Gustave Roussy |
| Principal Investigator: | Mitchell S Cairo, MD | Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia University |
| Principal Investigator: | Mary Gerrard, MD | Sheffield Children's Hospital |
More Information
No publications provided
| Responsible Party: | Institut Gustave Roussy |
| ClinicalTrials.gov Identifier: | NCT00162656 History of Changes |
| Other Study ID Numbers: | FAB LMB96 |
| Study First Received: | September 7, 2005 |
| Last Updated: | March 27, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Gustave Roussy:
|
B-Cell Lymphoma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013