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NCT03240211 · ClinicalTrials.gov registry record · Phase 1
Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
A Phase 1 study of CTCL and PTCL, sponsored by University of Virginia.
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT03240211: Active Phase 1 study of CTCL and PTCL, sponsored by University of Virginia.
NCT03240211 is a Phase 1 study of CTCL and PTCL that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 37 participants, below the 67-participant average among 4 other CTCL trials with a reported enrollment target (45% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03240211, a Phase 1 study of CTCL and PTCL, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine.
Primary Outcome
The study dose level that is recommended after the maximum target sample size of 10 participants are accrued to each arm
Interventions
- DRUG Pembrolizumab
- DRUG Decitabine
- DRUG Pralatrexate
Study Locations (2)
Pennsylvania
- Allegheny Health Network - Pittsburgh
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2026-05-25 |
| Phase | Phase 1 |
What the registry record for NCT03240211 still lists
NCT03240211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 67-participant average among 4 other CTCL trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with CTCL appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03240211 reports a single indexed study location in Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT03240211 about?
NCT03240211 is a clinical study titled "Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL". This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at t...
What is the current status of trial NCT03240211?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2022-02-02. Estimated completion is 2026-05-25.
What conditions does trial NCT03240211 study?
This clinical trial studies the following conditions: CTCL, PTCL.
What interventions are being tested in trial NCT03240211?
The interventions under investigation include: Pembrolizumab (DRUG), Decitabine (DRUG), Pralatrexate (DRUG).
Who is sponsoring clinical trial NCT03240211?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03240211 being conducted?
This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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