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NCT00865969 · ClinicalTrials.gov registry record · Phase 2
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
A Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT00865969: Completed Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Spectrum Pharmaceuticals.
NCT00865969 is a Phase 2 study of Peripheral T-Cell Lymphoma that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 129 participants, above the 102-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865969, a Phase 2 study of Peripheral T-Cell Lymphoma, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Belinostat
Study Locations (20)
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- Kellogg Cancer Care Center - Evanston
- Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland - Niles
- Illinois CancerCare, P.C. - Peoria
California
- City of Hope National Medical Center - Duarte
- Wilshire Oncology Medical Group, Inc - La Verne
- Comprehensive Cancer Center - Palm Springs
Connecticut
- Yale Cancer Center-Section of Medical Oncology - New Haven
- Oncology Associates of Bridgeport - Trumbull
Massachusetts
- Dana Farber Cancer Institute - Boston
- Boston University Medical Center - Boston
Michigan
- Karmanos Cancer Institute - Detroit
- Henry Ford Health System - Detroit
Missouri
- Saint Louis University - St Louis
- Washington University School of Medicine - St Louis
Florida
- Boca Raton Clinical Research Associates - Boca Raton
Georgia
- Georgia Health Sciences University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2008-12-15 |
| Est. Completion | 2014-10-27 |
| Phase | Phase 2 |
What the finished NCT00865969 record still lists
NCT00865969 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Belinostat is the first listed.
NCT00865969 names 20 study sites across 10 states, led by Illinois, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00865969 about?
NCT00865969 is a clinical study titled "Belinostat in 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.
What is the current status of trial NCT00865969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2008-12-15. Estimated completion is 2014-10-27.
What conditions does trial NCT00865969 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.
What interventions are being tested in trial NCT00865969?
The interventions under investigation include: Belinostat (DRUG).
Who is sponsoring clinical trial NCT00865969?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00865969 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00865969's enrollment target sits among peer trials
129 8th of 34 higher than 27 of 34 other Peripheral T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral T-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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