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