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Recruiting Phase 2 Interventional

Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis

ClinicalTrials.gov ID: NCT04380740

Public ClinicalTrials.gov record NCT04380740. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 6:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: "ABA3"

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.

Study identification

NCT ID
NCT04380740
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Boston Children's Hospital
Other
Enrollment
160 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 29, 2022
Primary completion
Apr 30, 2027
Completion
May 31, 2028
Last update posted
May 10, 2026

2022 – 2028

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
City Of Hope National Medical Center Duarte California 91010 Active, not recruiting
Moffitt Cancer Center Tampa Florida 33612 Active, not recruiting
Emory University/Winship Cancer Center Atlanta Georgia 30322 Active, not recruiting
Children's Healthcare of Atlanta Atlanta Georgia 30329 Recruiting
University of Chicago Chicago Illinois 60637 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Active, not recruiting
Boston Children's Hospital Boston Massachusetts 02115 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Active, not recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Active, not recruiting
University of Michigan Ann Arbor Michigan 48109 Active, not recruiting
Washington University St. Louis St Louis Missouri 63110 Withdrawn
University of Rochester Rochester New York 14642 Recruiting
Cincinnati Children's Hospital Cincinnati Ohio 45229 Active, not recruiting
Oregon Health and Sciences University Portland Oregon 97239 Active, not recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04380740, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 10, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04380740 live on ClinicalTrials.gov.

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