A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Rituximab-Aracytine High Dose-Dexamethasone (T-R-DHA) for the Treatment of Patients in Relapsed/Refractory Mantle Cell Lymphoma
This is a three arms trial that investigates Temsirolimus (Torisel™) in combination with
three chemotherapy regimens (R-CHOP, R-FC or R-DHA).
- To assess the feasibility of these three chemotherapy regimens in combination with
Temsirolimus (Torisel™) and to assess the incidence of dose limiting toxicities (DLT) during
the two first cycles of Temsirolimus (Torisel™) in combination with three chemotherapy
regimens in order to determine the maximal tolerate dose (MTD) in a dose escalating study
design in a population of patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
- To assess the safety of the association Temsirolimus with the three chemotherapy
- To determine the efficacy of the association of Temsirolimus (Torisel™) and these three
chemotherapy regimens after 4 cycles and after 6 cycles at the end of treatment:
response rate and complete response rate (CR), progression-free survival (PFS),
response duration (RD) and overall survival (OS).
All subjects who received at least one dose of Temsirolimus (Torisel™) will be considered
evaluable and will be included in the safety analysis.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities (DLT)
The evaluable for DLT population is the subset of patients from all treated population with a DLT assessment at the two first cycles.
Steven LE GOUILL, Professor
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)