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LMBA02 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
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burkitt Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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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
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LMBA02 Protocol for Patients With a Burkitt Lymphoma

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