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LMBA02 Protocol for Patients With a Burkitt Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 12, 2005
Last updated: September 7, 2006
Last verified: September 2006
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180882

Contact: Vincent RIBRAG, MD 33 1 42 11 43 47

Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Vincent RIBRAG, MD    33 1 42 11 43 47   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Vincent RIBRAG, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00180882     History of Changes
Other Study ID Numbers: LMBA02
Study First Received: September 12, 2005
Last Updated: September 7, 2006

Additional relevant MeSH terms:
Burkitt Lymphoma
Neoplasms by Histologic Type
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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on July 19, 2017