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NCT03924401 · ClinicalTrials.gov registry record · Phase 2
Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant
A Phase 2 study of Graft-Versus-Host Disease, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 9
- Study locations
NCT03924401: Active Phase 2 study of Graft-Versus-Host Disease, sponsored by Emory University.
NCT03924401 is a Phase 2 study of Graft-Versus-Host Disease that is active but no longer recruiting, run by Emory University. The registered enrollment target is 30 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924401, a Phase 2 study of Graft-Versus-Host Disease, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 9
- Study locations
Study Summary
This trial will see if extended abatacept administration (combined with a standard regimen of tacrolimus and mycophenolate mofetil) will prevent acute and chronic graft-versus-host disease (GVHD) in children and adolescents receiving unrelated donor (URD) hematopoietic stem cell transplantation (HSCT), without compromising their engraftment or reconstitution of protective immunity to infection. The study will enroll 30 pediatric patients with serious non-malignant hematologic diseases (NMHD) undergoing URD HSCT. The trial will include patients with 7/8 donors and those with 8/8 (matched) donors. All participants will receive 8 doses of abatacept. Recruitment is expected to last for about 2 years and participants will be followed for up to 3 years.
Primary Outcome
Event-free survival is a composite endpoint defined as rejection-free, severe GVHD-free survival. Events for this outcome include death, severe (grade II-IV) acute GVHD up to day 100, moderate to severe chronic GVHD up to 1 year, and/or graft rejection up to 1 year.
Conditions Studied
Interventions
- DRUG Abatacept
Study Locations (9)
New York
- Oishei Children's Hospital - Buffalo
- Columbia University Irving Medical Center - New York
Alabama
- Children's of Alabama - Birmingham
Delaware
- Nemours/Alfred I. DuPont Hospital for Children - Wilmington
Georgia
- Childrens Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
Mississippi
- University of Mississippi Medical Center, Children's Center for Cancer and Blood Disorders - Jackson
New Jersey
- Hackensack Meridian Health - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What the registry record for NCT03924401 still lists
NCT03924401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Abatacept is the first listed.
NCT03924401 lists 9 locations in 8 states (New York, Alabama, Delaware).
Frequently Asked Questions
What is clinical trial NCT03924401 about?
NCT03924401 is a clinical study titled "Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant". This trial will see if extended abatacept administration (combined with a standard regimen of tacrolimus and mycophenolate mofetil) will prevent acute and chronic graft-versus-host disease (GVHD) in children and adolescents receiving unrelated donor (URD) hematopoietic stem cell transplantation (HSC...
What is the current status of trial NCT03924401?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-08-22. Estimated completion is 2027-03-01.
What conditions does trial NCT03924401 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease.
What interventions are being tested in trial NCT03924401?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT03924401?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924401 being conducted?
This trial has 9 study locations across Alabama, Delaware, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03924401's enrollment target sits among peer trials
30 29th of 38 higher than 8 of 38 other Graft-Versus-Host Disease trials
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