Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

This study is ongoing, but not recruiting new patients.

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 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a single-agent comparator in countries that do not permit its use at this time.

Study Type:  Interventional

Study Design:  

Allocation:  Randomized
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Official 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

Conditions:

Relapsed Peripheral T-Cell Lymphoma
Refractory Peripheral T-Cell Lymphoma                              

Interventions:  

Drug:  Alisertib 
Drug:  Pralatrexate 
Drug:  Gemcitabine 
Drug:  Romidepsin

Phase:  Phase 3

External Link:  https://clinicaltrials.gov/show/NCT01482962