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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: Completed Phase 2 study of Graft-Versus-Host Disease and Graft Vs Host Disease, sponsored by Regimmune Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Acute GVHD will be graded and assessed according to modified KEYSTONE criteria and the severity grade (Grade II through IV) were captured up through the first 100 days post-transplant
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-11-25 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 2 |
What the finished NCT04014790 record still lists
NCT04014790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 81-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (40% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT04014790's enrollment target sits among peer trials
49 13th of 38 higher than 26 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease 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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