Spots Global Cancer Trial Database for Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL).
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Trial Identification
Brief Title: Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL).
Official Title: 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
Study ID: NCT01389427
Conditions
Interventions
Study Description
Brief Summary: This is a multicenter, open label, three arms, Phase IB study. A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL): * Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks for 6 cycles, * Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles, * Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6 cycles.
Detailed Description: This is a three arms trial that investigates Temsirolimus (Torisel™) in combination with three chemotherapy regimens (R-CHOP, R-FC or R-DHA). Primary Objective: - 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). Secondary objectives: * To assess the safety of the association Temsirolimus with the three chemotherapy regimens, * 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU de Grenoble MICHALLON, Grenoble Cedex 9, Hôpital Nord 217, France
Hôtel Dieu - Université de Nantes, Nantes cedex, Place Alexis Ricordeau, France
Hôpital Henri Mondor, Creteil, , France
CHU de Dijon, Dijon, , France
Hôpital Saint-Eloi, Montpellier, , France
Hôpital Saint Louis, Paris, , France
Hôpital Necker, Paris, , France
Groupe hospitalier Sud Hôpital Haut-Lévêque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU Pontchaillou, Rennes, , France
CHU de Tours - Hôpital Bretonneau, Tours, , France
Contact Details
Name: Steven LE GOUILL, Professor
Affiliation:
Role: PRINCIPAL_INVESTIGATOR
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