Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
- Registration Number
- NCT00865969
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Belinostat Belinostat Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
- Primary Outcome Measures
Name Time Method Objective Response Rate 24 months Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.
- Secondary Outcome Measures
Name Time Method Time to Response 24 months Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) 24 months A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.
Time to Progression 24 months Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Duration of Response 24 months The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Progression Free Survival 24 months Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Overall Survival 24 months Overall Survival was the time from first administration of study treatment until the date of death.
Trial Locations
- Locations (117)
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Wilshire Oncology Medical Group, Inc
🇺🇸La Verne, California, United States
Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Yale Cancer Center-Section of Medical Oncology
🇺🇸New Haven, Connecticut, United States
Oncology Associates of Bridgeport
🇺🇸Trumbull, Connecticut, United States
Boca Raton Clinical Research Associates
🇺🇸Boca Raton, Florida, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Kellogg Cancer Care Center
🇺🇸Evanston, Illinois, United States
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