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Trial Title:
LMBA02 Protocol for Patients With a Burkitt Lymphoma
NCT ID:
NCT00180882
Condition:
Burkitt Lymphoma
Conditions: Official terms:
Burkitt Lymphoma
Lymphoma
Rituximab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
rituximab
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent RIBRAG, MD
Phone:
33 1 42 11 43 47
Email:
ribrag@igr.fr
Start date:
October 2004
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00180882
