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Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Sponsor: Boston Children's Hospital
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
Conditions
Interventions
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.
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