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NCT00364923 · ClinicalTrials.gov registry record · Phase 2
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT00364923: Completed Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Acrotech Biopharma.
NCT00364923 is a Phase 2 study of Peripheral T-Cell Lymphoma that has completed, run by Acrotech Biopharma. The registered enrollment target is 115 participants, above the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00364923, a Phase 2 study of Peripheral T-Cell Lymphoma, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary * Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL * Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Primary Outcome
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
Conditions Studied
Interventions
- DRUG Pralatrexate Injection
Study Locations (20)
New York
- Memorial Sloan-Kettering Cancer Center - New York
- New York Presbyterian Hospital - New York
- Columbia University Medical Center - New York
- University of Rochester Cancer Center - Rochester
California
- City of Hope National Medical Center - Duarte
- University of California at Los Angeles - Los Angeles
Other
- Cliniques Universitaire Saint-Luc - Brussels
- Cliniques Universitaires UCL - Yvoir
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago Hospital - Chicago
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Louisiana
- Tulane Cancer Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2006-08 |
| Est. Completion | 2009-02-24 |
| Phase | Phase 2 |
What the finished NCT00364923 record still lists
NCT00364923 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Pralatrexate Injection is the first listed.
NCT00364923 names 20 study sites across 15 states, led by New York, California, Other.
Frequently Asked Questions
What is clinical trial NCT00364923 about?
NCT00364923 is a clinical study titled "Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma". Primary • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary * Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid suppl...
What is the current status of trial NCT00364923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2006-08. Estimated completion is 2009-02-24.
What conditions does trial NCT00364923 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.
What interventions are being tested in trial NCT00364923?
The interventions under investigation include: Pralatrexate Injection (DRUG).
Who is sponsoring clinical trial NCT00364923?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00364923 being conducted?
This trial has 20 study locations across California, Connecticut, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peripheral T-Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00364923's enrollment target sits among peer trials
115 9th of 34 higher than 26 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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