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Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant

NCT03924401 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-25

No results posted yet for this 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

Interventions

DRUG

Abatacept

All patients will receive 8 doses of abatacept (10 mg/kg intravenously on days -1, +5, +14, +28, +56, +84, +112, and +150) in addition to conventional GVHD prophylaxis.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Sickle Cell Transplant Advocacy & Research Alliance (STAR)

    collaborator UNKNOWN

  • Aflac Cancer and Blood Disorders Center

    collaborator UNKNOWN

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • John Horan, MD · Emory University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924401 on ClinicalTrials.gov