LMBA02 Protocol for Patients With a Burkitt Lymphoma

Phase 3

• Conditions: Burkitt Lymphoma

• Registration Number: NCT00180882
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Event free survival from date of first randomization

Secondary Outcome Measures

Name	Time	Method
Complete and partial response rate, overall survival, toxicity

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France