Treatment of Mature B-cell Lymphoma/Leukaemia

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00162656

Collaborator

(none)

848

Enrollment

Locations

Arms

180

Duration (Months)

282.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and
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 or Disease	Intervention/Treatment	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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

848 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

May 1, 1996

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Event free survival [3 years]
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)

Secondary Outcome Measures

Survival [3 years]
long term toxicity [10 years]
long term toxicity: cardiotoxicity, impaired fertility, secondary malignancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Morgan Stanley Childrens Hospital of New York Presbyterian	New York	New York	United States
2	Institut Gustave Roussy	Villejuif		France	94800
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustave Roussy, Cancer Campus, Grand Paris

ClinicalTrials.gov Identifier:

NCT00162656

Other Study ID Numbers:

FAB LMB96

First Posted:

Sep 13, 2005

Last Update Posted:

Mar 28, 2012

Last Verified:

Mar 1, 2012

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris

B-Cell Lymphoma

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Cyclophosphamide

Study Results

No Results Posted as of Mar 28, 2012