LMBA02 Protocol for Patients With a Burkitt Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Rituximab

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