Overview

Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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 with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborator:
Hoffmann-La Roche
Treatments:
Chlorambucil
Cyclophosphamide
Dexamethasone
Doxorubicin
Melphalan
Rituximab
Vincristine
Criteria
Inclusion Criteria:

- 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 Criteria:

- Other type of lymphoma

- age<18 ou > 66 years

- Informed consent not signed

- anterior cancer

- Contraindication to rituximab

- Cardiac insufficiency