Treatment of Mature B-cell Lymphoma/Leukaemia

NCT00162656 | Completed Phase 3 DMC

• 1 other identifier: FAB LMB96
• Study Type: interventional
• Target: 848
• Locations: 3 countries
• Sites: 3

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 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

B-Cell Lymphoma

Keywords

B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event free survival

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

  3 years

Secondary Outcomes (2)

• Survival

  3 years

• long term toxicity

  10 years

Study Arms (6)

Standard LMB B

ACTIVE COMPARATOR

Drug: LMB B

LMB B without COPADM3

EXPERIMENTAL

Drug: without COPADM3

LMB B with half cyclophosphamide

EXPERIMENTAL

Drug: half cyclophosphamide

LMB B without COPADM3 and with half cyclophosphamide

EXPERIMENTAL

Drug: half cyclophosphamide; Drug: without COPADM3

LMB C standard

ACTIVE COMPARATOR

Drug: LMB C

LMB C with mini CYVE and without 3 maintenance courses

EXPERIMENTAL

Drug: mini CYVE, without 3 maintenance courses

Interventions

half cyclophosphamide DRUG

LMB B with half cyclophosphamide; LMB B without COPADM3 and with half cyclophosphamide

without COPADM3 DRUG

LMB B without COPADM3; LMB B without COPADM3 and with half cyclophosphamide

mini CYVE, without 3 maintenance courses DRUG

LMB C with mini CYVE and without 3 maintenance courses

LMB B DRUG

Standard LMB B

LMB C DRUG

LMB C standard

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Anaplastic large cell Ki 1 positive lymphomas
• Previous chemotherapy.
• Congenital immunodeficiency
• Prior organ transplantation
• Previous malignancy of any type
• Known HIV positivity

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (3)

Morgan Stanley Childrens Hospital of New York Presbyterian

New York, New York, United States

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Sheffield Children's Hospital

Sheffield, United Kingdom

Location

Related Publications (1)

• Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.

  PMID: 30117142 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 13, 2005
• Study Start: May 1, 1996
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2011
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

GB (1); US (1); FR (1)