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
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