Back to resultsLMBA02 Protocol for Patients With a Burkitt Lymphoma
Primary Purpose
Burkitt Lymphoma
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Burkitt Lymphoma
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
Sites / Locations
- Institut Gustave RoussyRecruiting
Outcomes
Primary Outcome Measures
Event free survival from date of first randomization
Secondary Outcome Measures
Complete and partial response rate, overall survival, toxicity
Full Information
NCT ID
NCT00180882
First Posted
September 12, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00180882
Brief Title
LMBA02 Protocol for Patients With a Burkitt Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
Event free survival from date of first randomization
Secondary Outcome Measure Information:
Title
Complete and partial response rate, overall survival, toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent RIBRAG, MD
Phone
33 1 42 11 43 47
Email
ribrag@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent RIBRAG, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent RIBRAG, MD
Phone
33 1 42 11 43 47
Email
ribrag@igr.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
27080498
Citation
Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. doi: 10.1016/S0140-6736(15)01317-3. Epub 2016 Apr 11.
Results Reference
derived
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LMBA02 Protocol for Patients With a Burkitt Lymphoma
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