Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04380740
PHASE2

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-03-30

Completion Date

2028-06

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DRUG

Placebo

During the extended dosing of abatacept, those randomized to receive 4 doses will receive a placebo consisting of an equal volume of normal saline solution.

DRUG

Abatacept

Investigational prophylaxis with extended-dosing abatacept, a calcineurin inhibitor and methotrexate.

Locations (14)

City Of Hope National Medical Center

Duarte, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University/Winship Cancer Center

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University St. Louis

St Louis, Missouri, United States

University of Rochester

Rochester, New York, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States