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LMBA02 Protocol for Patients With a Burkitt Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180882
First received: September 12, 2005
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00180882     History of Changes
Other Study ID Numbers: LMBA02
Study First Received: September 12, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 19, 2013