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NCT04014790 · ClinicalTrials.gov registry record · Phase 2

RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

A Phase 2 study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Regimmune Corporation.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target
7
Study locations

NCT04014790 is a Phase 2 study of Graft-Versus-Host Disease and Graft Vs Host Disease that has completed, run by Regimmune Corporation. The registered enrollment target is 49 participants, below the 81-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (40% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT04014790, a Phase 2 study of Graft-Versus-Host Disease and Graft Vs Host Disease, has completed, sponsored by Regimmune Corporation.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target
7
Study locations

Study Summary

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

Conditions Studied

Graft-Versus-Host Disease Graft Vs Host Disease Acute-graft-versus-host Disease Prevention of aGVHD

Interventions

  • DRUG Standard of Care
  • DRUG RGI-2001

Study Locations (7)

California

  • UCLA Medical Center - Los Angeles

Florida

  • University of Miami, Sylvester Comprehensive Cancer Center - Miami

Maryland

  • University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Michigan

  • Henry Ford Health System - Detroit

New York

  • Columbia University Irving Medical Center - New York

Ohio

  • Ohio State University Wexner Medical Center - Columbus

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2019-11-25
Est. Completion 2023-04-03
Phase Phase 2

Sponsor

Regimmune Corporation

2 total trials

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What the Registry Record Tells You About NCT04014790

The ClinicalTrials.gov registry entry for NCT04014790 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 81-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (40% lower). The listed sponsor is Regimmune Corporation, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT04014790 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT04014790 about?

NCT04014790 is a clinical study titled "RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation". This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subject...

What is the current status of trial NCT04014790?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2019-11-25. Estimated completion is 2023-04-03.

What conditions does trial NCT04014790 study?

This clinical trial studies the following conditions: Graft-Versus-Host Disease, Graft Vs Host Disease, Acute-graft-versus-host Disease, Prevention of aGVHD.

What interventions are being tested in trial NCT04014790?

The interventions under investigation include: Standard of Care (DRUG), RGI-2001 (DRUG).

Who is sponsoring clinical trial NCT04014790?

This trial is sponsored by Regimmune Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04014790 being conducted?

This trial has 7 study locations across California, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.