At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Alisertib, Pralatrexate, and 2 other interventions for Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma. Completed, enrolled 271 participants across 151 sites in 31 countries.
Detailed Summary
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.
Study Details
Timeline
Interventions
Alisertib enteric coated tablets
Pralatrexate IV infusion
Gemcitabine IV infusion
Romidepsin IV infusion