Know Cancer

or
forgot password

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


Phase 3
6 Months
20 Years
Not Enrolling
Both
B-Cell Lymphoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event free survival

Outcome Description:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Catherine Patte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

FAB LMB96

NCT ID:

NCT00162656

Start Date:

May 1996

Completion Date:

May 2011

Related Keywords:

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

Name

Location

Morgan Stanley Childrens Hospital of New York PresbyterianNew York, New York