NCT00865969

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Belinostat

Timeline

• Start date: 2008-12-15
• Primary completion: 2013-11-05
• Completion: 2014-10-27
• First posted: 2009-03-20
• Last updated: 2021-10-29
• Results posted: 2021-09-16

Locations

117 sites across 17 countries: United States, Belgium, Canada, Croatia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Slovakia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study