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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 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.

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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.

Conditions Studied

Lymphoma, T-Cell

Interventions

  • DRUG Durvalumab
  • DRUG Pralatrexate
  • DRUG Romidepsin
  • DRUG 5-Azacitidine

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2018-05-30
Est. Completion 2023-02
Phase Phase 1

Sponsor

University of Virginia

449 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03161223

The ClinicalTrials.gov registry entry for NCT03161223 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 9 other Lymphoma, T-Cell trials with a reported enrollment target (35% higher). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.