LMBA02 Protocol for Patients With a Burkitt Lymphoma

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2006

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00180882

Purpose

To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.

Condition	Intervention	Phase
Burkitt Lymphoma	Drug: rituximab	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

Event free survival from date of first randomization

Secondary Outcome Measures:

Complete and partial response rate, overall survival, toxicity

Estimated Enrollment:	260
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age : 18 years or older
Histologically or cytologically proven Burkitt lymphoma according to the WHO classification
WHO performance < 3
Informed consent

Exclusion Criteria:

Known HIV positive infection
Positive serology for HCV and HBV (except after vaccination)
Patients previously treated for lymphoma
cardiac disease that contradict anthracycline chemotherapy
Psychological or psychiatric condition who contradict steroids therapy
Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L)
Cirrhosis or severe hepatic failure unrelated to the lymphoma
Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Primary organ transplant or other immunosuppressive conditions Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180882

Contacts

Contact: Vincent RIBRAG, MD

33 1 42 11 43 47

ribrag@igr.fr

Locations

France
Institut Gustave Roussy	Recruiting
Villejuif, France, 94800
Contact: Vincent RIBRAG, MD 33 1 42 11 43 47 ribrag@igr.fr

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Principal Investigator:

Vincent RIBRAG, MD

Institut Gustave Roussy

More Information

Study ID Numbers:	LMBA02
Study First Received:	September 12, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00180882
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Herpesviridae Infections
Virus Diseases
Lymphoma, B-Cell
Lymphatic Diseases
Burkitt's lymphoma

Burkitt Lymphoma
B-cell lymphomas
Epstein-Barr Virus Infections
DNA Virus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Tumor Virus Infections
Neoplasms, Experimental

ClinicalTrials.gov processed this record on January 16, 2009