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Phase 3 Trial of Alisertib vs Investigator's Choice in Relapsed or Refractory Peripheral T-Cell Lymphoma
2011-003545-18Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2012
- Countries
- 1
- Sponsor
- Millennium Pharmaceuticals, Inc
- Modality
- Small Molecules
- Drugs
- alisertib
- Conditions
- peripheral T-cell lymphoma (PTCL)
01
Overview
Phase 3, randomised, open-label trial of alisertib in peripheral T-cell lymphoma (PTCL) (2 arms), sponsored by Millennium Pharmaceuticals, Inc. Primary endpoint: Overall response rate. Started Apr 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Alisertib
Patients receive alisertib (MLN8237) as single-agent therapy.
Investigator's Choice
Patients receive investigator’s choice of single-agent gemcitabine or pralatrexate.
03
Who it enrols
Adults (≥18 years) with relapsed or refractory peripheral T-cell lymphoma are eligible; patients with known central nervous system lymphoma are excluded.
04
Endpoints
Primary
Overall response rate
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