Burkitt Lymphoma
Conditions
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.
Interventions
DRUGrituximab
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival from date of first randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete and partial response rate, overall survival, toxicity | — |
Countries
France
Contacts
Primary ContactVincent RIBRAG, MD
Outcome results
None listed