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NCT03070964 · ClinicalTrials.gov registry record · Phase 2
A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma
A Phase 2 study, sponsored by PharmaMar.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03070964: Clinical Trial Phase 2 study, sponsored by PharmaMar.
NCT03070964 is a Phase 2 study that was terminated before completion, run by PharmaMar. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070964, a Phase 2 study, was terminated before completion, sponsored by PharmaMar.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Prospective, multicenter, phase II clinical trial to determine the efficacy of plitidepsin in patients with relapsed/refractory (R/R) angioimmunoblastic Tcell lymphoma (AITL).This is an international, multicenter study (with approximately 17 investigative sites).
Primary Outcome
The study protocol established that the analysis of the primary endpoint should have been done once a total of 60 patients have received plitidepsin, with two futility analyses planned after the inclusion of approximately 15 and 30 patients, respectively. However, only a total of 14 patients were included, of whom 13 were treated, and 12 were evaluable for the primary efficacy endpoint (ORR per IRC in the "Per Protocol Patients" population). As a result of slow patient accrual, the study was clo
Interventions
- DRUG plitidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-10-25 |
| Est. Completion | 2018-07 |
| Phase | Phase 2 |
Why NCT03070964 stopped before completion
NCT03070964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which plitidepsin is the first listed.
NCT03070964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070964 about?
NCT03070964 is a clinical study titled "A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma". Prospective, multicenter, phase II clinical trial to determine the efficacy of plitidepsin in patients with relapsed/refractory (R/R) angioimmunoblastic Tcell lymphoma (AITL).This is an international, multicenter study (with approximately 17 investigative sites).
What is the current status of trial NCT03070964?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2016-10-25. Estimated completion is 2018-07.
What interventions are being tested in trial NCT03070964?
The interventions under investigation include: plitidepsin (DRUG).
Who is sponsoring clinical trial NCT03070964?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070964's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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