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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Tran

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 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 Summary:

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


Sponsor: French Innovative Leukemia Organisation

Current Primary Outcome: failure event free survival at 3 years [ Time Frame: 3 YEARS ]

Original Primary Outcome: failure event free survival at 3 years

Current Secondary Outcome:

  • Response rate after 4 R-(VAD+C) cycles [ Time Frame: 4 months ]
  • Incident of Molecular residual disease on blood, marrow and stem cell collection [ Time Frame: 3 years ]
  • Safety of the R-( VAD+C) regimen [ Time Frame: 8 months ]
  • Overall survival [ Time Frame: 3 years ]
  • Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging [ Time Frame: 8 months ]


Original Secondary Outcome:

  • - Response rate after 4 R-(VAD+C) cycles
  • - Incident of Molecular residual disease on blood, marrow and stem cell collection
  • - Safety of the R-( VAD+C) regimen
  • - Overall survival
  • - Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging


Information By: French Innovative Leukemia Organisation

Dates:
Date Received: January 31, 2006
Date Started: February 2002
Date Completion:
Last Updated: February 11, 2009
Last Verified: February 2009