drugset / Trial / NCT01078142
Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma
Phase 1/2
Completed
39 enrolled
Georg Hess, MD
Mundipharma Pte Ltd. · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, open label, single arm, phase I/II study. There will be no placebo usage within this trial. Phase I: Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle cell lymphoma. Phase II: Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT dose Secondary: To determine the complete remission rate, progression free survival rate and overall survival rate and to investigate safety and tolerability of BERT.
Timeline
- Start
- 2010-02-02
- Primary completion
- 2017-09-08
- Completion
- 2017-09-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustin | Unknown | 90 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Subject | Temsirolimus | Small molecule | 25 mg | — |
| Subject | Temsirolimus | Small molecule | 50 mg | — |
| Subject | Temsirolimus | Small molecule | 75 mg | — |