Status:
COMPLETED
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years wi...
Detailed Description
All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4 cycles of (R VAD +C) . The responders more than RP \> 50% received 2 other cycles before to be intensified wit...
Eligibility Criteria
Inclusion
- Mantel cell lymphoma
- CD 20+
- At diagnosis or without anterior chemotherapy
- Age \>18 and \< 66 years
- Ann Arbor ii, III or IV
- ECOG \<3
- contraindication for rituximab treatment
- Informed consent signed
- No cancer anteriory
- Renal and hepatic function compatible with the treatment
- Ventricular Fraction \> 50 % with echographic method and \> 40% with isotopic method
Exclusion
- Other type of lymphoma
- age\<18 ou \> 66 years
- Informed consent not signed
- anterior cancer
- Contraindication to rituximab
- Cardiac insufficiency
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00285389
Start Date
February 1 2002
End Date
December 1 2008
Last Update
February 12 2009
Active Locations (3)
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1
Regional university hospital
Besançon, France, 25000
2
Regional university hospital
Rennes, France, 35033
3
REgional Hospital
Tours, France, 37000