drugset / Trial / 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).
Phase 1/2
Completed
41 enrolled
The Lymphoma Academic Research Organisation
French Innovative Leukemia Organisation · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2015-05
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Fludarabine | Small molecule | — | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Temsirolimus | Small molecule | 15 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 25 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 50 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 75 mg | Intravenous |
| Subject | Vincristine | Small molecule | — | — |