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NCT00426764 · ClinicalTrials.gov registry record · Phase 2
A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT00426764: Completed Phase 2 study, sponsored by Celgene.
NCT00426764 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00426764, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
Primary Outcome
Complete Response (CR): \>75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed \>75% in the sum of the product diameters (S
Interventions
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2007-06-19 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 2 |
What the finished NCT00426764 record still lists
NCT00426764 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Romidepsin is the first listed.
NCT00426764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00426764 about?
NCT00426764 is a clinical study titled "A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma". The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
What is the current status of trial NCT00426764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2007-06-19. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT00426764?
The interventions under investigation include: Romidepsin (DRUG).
Who is sponsoring clinical trial NCT00426764?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00426764's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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