LMBA02 Protocol for Patients With a Burkitt Lymphoma

September 7, 2006 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event free survival from date of first randomization

Secondary Outcome Measures

Outcome Measure
Complete and partial response rate, overall survival, toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMBA02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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