A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator’s Choice (Selected Single Agent) in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
Update: this study is closed to enrollment.
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for people with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL). The sponsor is Millennium Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Jia Ruan. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at firstname.lastname@example.org.
The purpose of the study is to assess how well people with PTCL respond to treatment with the experimental drug Alisertib (also known as MLN8237) as compared to other PTCL treatments.
Study participants will be randomly assigned to receive Alisertib or one of the following drugs used to treat PTCL: pralatrexate, romidepsin or gemcitabine.
Alisertib has been developed to interfere with cell division, which is required for normal and cancer cell growth. By blocking an enzyme that cells need to reproduce, alistertib may slow the growth of cancer cells.
- PTCL relapsed or refractory to at least 1 prior systemic, cytoxic therapy for PTCL
- Must have received convential therapy (not experimental) as prior therapy
Study participants will be randomly assigned to one of two study arms:
- Arm A: Alisertib tablet twice daily by mouth for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle for up to 32 cycles of treatment (2 years)
- Arm B: Single-arm comparator. Participants will be assigned by the investigator to receive 1 of the following for up to 2 years:
- Pralatrexate via infusion once weekly for 6 weeks in 7-week cycles. Cycles repeated every 7 weeks
- Romidepsin via infusion on Days 1, 8 and 15 of a 28-day cycle. Cycles repeated every 28 days
- Gemcitabine via infusion on Days 1, 8 and 15 of a 28-day cycle. Cycles repeated every 28 days