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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180882 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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LMBA02 Protocol for Patients With a Burkitt Lymphoma
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Scientific title:
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Date of first enrolment:
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October 2004 |
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Target sample size:
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260 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00180882 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Vincent RIBRAG, MD |
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Address:
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Telephone:
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33 1 42 11 43 47 |
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Email:
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ribrag@igr.fr |
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Affiliation:
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Name:
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Vincent RIBRAG, MD |
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Address:
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Telephone:
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33 1 42 11 43 47 |
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Email:
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ribrag@igr.fr |
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Affiliation:
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Name:
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Vincent RIBRAG, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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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 minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burkitt Lymphoma
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Intervention(s)
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Drug: rituximab
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Primary Outcome(s)
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Event free survival from date of first randomization
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Secondary Outcome(s)
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Complete and partial response rate, overall survival, toxicity
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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