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LMBA02 Protocol for Patients With a Burkitt Lymphoma

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ClinicalTrials.gov Identifier: NCT00180882
Recruitment Status : Unknown
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : September 11, 2006
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Burkitt Lymphoma Drug: rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Event free survival from date of first randomization

Secondary Outcome Measures :
  1. Complete and partial response rate, overall survival, toxicity


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Vincent RIBRAG, MD Gustave Roussy, Cancer Campus, Grand Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00180882     History of Changes
Other Study ID Numbers: LMBA02
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Lymphoma
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents