LMBA02 Protocol for Patients With a Burkitt Lymphoma

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Burkitt Lymphoma

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00180882

LMBA02

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)