Status:
COMPLETED
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Lymphoma Study Association
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lym...
Detailed Description
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated w...
Eligibility Criteria
Inclusion
- mantle cell lymphoma
- Initial immunophenotyping with CD20 and CD5.
- CD20+.
- t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
- Patient no previous treated.
- At least one tumor site accessible for assessment
- Aged \> 18 years \< 65
- ECOG \< or = 2.
- No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
- signed informed consent
- FEVG 50%
Exclusion
- other type of lymphoma
- ECOG \> or = 3
- relapse
- serology VIH + Hepatite +
- diabetis
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00921414
Start Date
September 1 2008
End Date
February 1 2017
Last Update
April 27 2018
Active Locations (1)
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1
Regional University Hospital
Nantes, France, 44093