Treatment of Mature B-cell Lymphoma/Leukaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00162656
First received: September 7, 2005
Last updated: March 27, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162656

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
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Catherine Patte, MD Gustave Roussy, Cancer Campus, Grand Paris
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: Gustave Roussy, Cancer Campus, Grand Paris
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 Gustave Roussy, Cancer Campus, Grand Paris:
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 August 28, 2014