A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.
Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.
The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.
Inclusion criteria:
Exclusion criteria:
Niles, Illinois 60714, United States
Memphis, Tennessee 38138, United States
Seattle, Washington 98109, United States
Nice, 6202, France
Homburg/Saar, 66424, Germany
Warsaw, Masovian Voivodeship 02-781, Poland
Lodz, 93-510, Poland
Warsaw, 04-141, Poland
Chelyabinsk, 454087, Russia
Moscow, 115478, Russia
Pretoria, 0002, South Africa
London, EC1A 7BE, United Kingdom