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

Study Status

Open to Enrollment

Study Description

This is a clinical trial for people with Peripheral T-Cell Lymphoma (PTCL) who have not responded to previous treatment or for whom the treatment is no longer effective. 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. 

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

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Disease Status and/or Stage

Relapsed/Refractory Peripheral T-Cell Lymphoma



Key Eligibility

  • Men and women age 18 and older
  • Peripheral T-Cell Lymphoma (PTCL) relapsed or refractory to at least 1 prior systemic, cytoxic therapy for PTCL
  • Must have received conventional therapy (not experimental) as prior therapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Jia Ruan, MD


Protocol ID


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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