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Treatment of Mature B-cell Lymphoma/Leukaemia

NCT00162656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 848

Last updated 2012-03-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

half cyclophosphamide

DRUG

without COPADM3

DRUG

mini CYVE, without 3 maintenance courses

DRUG

LMB B

DRUG

LMB C

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Catherine Patte, MD · Gustave Roussy, Cancer Campus, Grand Paris

  • Mitchell S Cairo, MD · Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia University

  • Mary Gerrard, MD · Sheffield Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-05-31
Primary Completion
2004-05-31
Completion
2011-05-31

Countries

  • United States
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00162656 on ClinicalTrials.gov