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).

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 31, 2015

Study Completion Date

September 30, 2015

Conditions
Mantle Cell Lymphoma Refractory
Interventions
DRUG

Torisel dose 15 mg and R-CHOP

Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 15 mg and R-FC

Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 15 mg and R-DHA

Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 25 mg and R-CHOP

Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 50 mg and R-CHOP

Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 75 mg and R-CHOP

Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 25 mg and R-FC

Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 50 mg and R-FC

Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 75 mg and R-FC

Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 25 mg and R-DHA

Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel dose 50 mg and R-DHA

Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

DRUG

Torisel 75 mg and R-DHA

Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).

Trial Locations (11)

21000

CHU de Dijon, Dijon

33604

Groupe hospitalier Sud Hôpital Haut-Lévêque, Pessac

34295

Hôpital Saint-Eloi, Montpellier

35003

CHU Pontchaillou, Rennes

37000

CHU de Tours - Hôpital Bretonneau, Tours

38043

CHU de Grenoble MICHALLON, Grenoble

44093

Hôtel Dieu - Université de Nantes, Nantes

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

75475

Hôpital Saint Louis, Paris

75743

Hôpital Necker, Paris

94010

Hôpital Henri Mondor, Créteil

All Listed Sponsors
collaborator

French Innovative Leukemia Organisation

OTHER

lead

The Lymphoma Academic Research Organisation

OTHER

NCT01389427 - 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). | Biotech Hunter | Biotech Hunter