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NCT03161223 · ClinicalTrials.gov registry record · Phase 1
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
A Phase 1 study of Lymphoma, T-Cell, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 148
- Enrollment target
- 1
- Study location
NCT03161223: Recruiting Phase 1 study of Lymphoma, T-Cell, sponsored by University of Virginia.
NCT03161223 is a Phase 1 study of Lymphoma, T-Cell that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 148 participants, above the 110-participant average among 9 other Lymphoma, T-Cell trials with a reported enrollment target (35% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161223, a Phase 1 study of Lymphoma, T-Cell, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 148 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, Phase 1/2a, dose-finding study with an initial phase 1 portion, articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying treatment Arm(s). The primary objective of the Phase 1 portion is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of: Durvalumab, oral 5-azacitidine, and romidepsin (Arm A); durvalumab, pralatrexate, and romidepsin (Arm B); durvalumab and romidepsin (Arm C); or durvalumab and oral 5-azacitidine (Arm D), in patients with peripheral T-cell lymphoma (PTCL). The safety and toxicity profile of these combinations will be evaluated throughout the entire study. If one or more of the combinations in Arms A, B, C, or D are found to be feasible and an MTD is established, the phase 2 portion of the study will be initiated for the combination(s) with the strongest efficacy signal provided acceptable toxicity.
Primary Outcome
The highest dose of study treatment that does not cause unacceptable side effects in patients with R/R PTCL in each study arm
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Pralatrexate
- DRUG Romidepsin
- DRUG 5-Azacitidine
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2023-02 |
| Phase | Phase 1 |
What NCT03161223 shows while recruiting
NCT03161223 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 9 other Lymphoma, T-Cell trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Lymphoma, T-Cell appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT03161223 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03161223 about?
NCT03161223 is a clinical study titled "Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma". This is an open-label, Phase 1/2a, dose-finding study with an initial phase 1 portion, articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying treatment Arm(s). The primary objective of the Phase 1 portion is to determine the maximum tolerated dose (MTD) and dose...
What is the current status of trial NCT03161223?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 148 participants. The study started on 2018-05-30. Estimated completion is 2023-02.
What conditions does trial NCT03161223 study?
This clinical trial studies the following conditions: Lymphoma, T-Cell.
What interventions are being tested in trial NCT03161223?
The interventions under investigation include: Durvalumab (DRUG), Pralatrexate (DRUG), Romidepsin (DRUG), 5-Azacitidine (DRUG).
Who is sponsoring clinical trial NCT03161223?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03161223 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma, T-Cell
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 NCT03161223's enrollment target sits among peer trials
148 5th of 9 higher than 5 of 9 other Lymphoma, T-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, T-Cell 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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