Refractory Peripheral T-Cell Lymphoma Clinical Trial
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
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.
The drug being tested in this study was Alisertib. Alisertib was tested to treat people who
have relapsed/refractory peripheral T-cell lymphoma (PTCL).
This study evaluated alisertib for the improvement in overall response rate (ORR) compared
with single-agent treatment, as selected by the investigator from the offered options of
pralatrexate, romidepsin (US only), or gemcitabine, in participants with relapsed or
refractory PTCL.
The study enrolled 271 patients. Participants were randomized (1:1) to one of 2 treatment
arms:
- Alisertib
- Investigator's choice (Pralatrexate, Romidepsin, or Gemcitabine)
This multi-center trial was conducted worldwide. The overall time to participate in this
study was approximately 5 years. Participants made multiple visits to the clinic, and then
were contacted by telephone up to 42-months after the last participant was randomized, or
until death, for follow-up assessment.
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