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LMBA02 Protocol for Patients With a Burkitt Lymphoma
Conditions
Burkitt Lymphoma
Conditions: official terms
Burkitt Lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: rituximab
Type: Drug
Overall Status
Recruiting
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.
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
- 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
Location
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Vincent RIBRAG, MD - 33 1 42 11 43 47 - ribrag@igr.fr
Start Date
October 2004
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Source
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page