A Phase III Study of Alisertib versus Standard Therapy in Patients with Recurrent or Persistent Peripheral T-Cell Lymphoma

Protocol
13-180
Full Title
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
Phase
III
Purpose

The purpose of this study is to compare the effectiveness of the investigational drug alisertib (MLN8237) with standard therapy in patients with peripheral T-cell lymphoma that has returned or persisted despite therapy. Alisertib works by blocking aurora kinase, an enzyme that helps cancer cells divide and reproduce. It is a pill that is taken orally (by mouth).

Patients will be randomly assigned to receive alisertib or another single-drug therapy for peripheral T-cell lymphoma (pralatrexate, romidepsin, or gemcitabine).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have peripheral T-cell lymphoma that has returned or continued to grow despite therapy and has progressed beyond the skin.
  • At least 4 weeks must have passed since the completion of prior therapy and entry into the study.
  • Patients may not have received previous treatment with an aurora kinase inhibitor, nor with all three of the other drugs used in this study (pralatrexate, romidepsin, and gemcitabine).
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases