Treatment of Mature B-cell Lymphoma/Leukaemia

B-Cell Lymphoma Clinical Trial

Official title:

Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162656
• Other study ID #: FAB LMB96
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: March 27, 2012
• Start date: May 1996
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: May 2011
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• half cyclophosphamide

• without COPADM3

• mini CYVE, without 3 maintenance courses

• LMB B

• LMB C

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif
United Kingdom	Sheffield Children's Hospital	Sheffield
United States	Morgan Stanley Childrens Hospital of New York Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival	Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)	3 years	No
Secondary	Survival		3 years	No
Secondary	long term toxicity	long term toxicity: cardiotoxicity, impaired fertility, secondary malignancy	10 years	Yes