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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Regional university hospital
Besançon, France
Regional university hospital
Rennes, France
REgional Hospital
Tours, France
failure event free survival at 3 years
Time frame: 3 YEARS
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
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0,4 mg/day day 1 to day 4