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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 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.

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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.

Conditions Studied

Graft-Versus-Host Disease

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

FieldValue
Enrollment Target 30 participants
Start Date 2019-08-22
Est. Completion 2027-03-01
Phase Phase 2

Sponsor

Emory University

1,208 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03924401

The ClinicalTrials.gov registry entry for NCT03924401 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.

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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.