NCT00285389

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

Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection. There is an clinical and molecular evaluation of the strategy

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Adriblastin
DRUG	dexamethasone
DRUG	Chlorambucil
DRUG	rituximab
DRUG	cyclophosphamide
DRUG	alkeran
PROCEDURE	Total body irradiation (8Gy/4fr)
DRUG	vincristine	0,4 mg/day day 1 to day 4

Timeline

• Start date: 2002-02-01
• Primary completion: 2005-12-01
• Completion: 2008-12-01
• First posted: 2006-02-02
• Last updated: 2009-02-12

Locations

3 sites across 1 country: France