LMBA02 Protocol for Patients With a Burkitt Lymphoma
Burkitt Lymphoma
Conditions: official terms
Burkitt Lymphoma
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: rituximab
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Vincent RIBRAG, MD - 33 1 42 11 43 47 - ribrag@igr.fr
Start Date
October 2004
Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page