Condition: Graft Vs Host Disease · Sponsor: Boston Children's Hospital
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.
This description comes directly from the study's public registry record.
Brandi M Bratrude, BA · 6179192197 · brandi.bratrude@childrens.harvard.edu
Always discuss trial participation with your own doctor first.
| City Of Hope National Medical Center | Duarte, California, United States | Active Not Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Active Not Recruiting |
| Emory University/Winship Cancer Center | Atlanta, Georgia, United States | Active Not Recruiting |
| Children's Healthcare of Atlanta | Atlanta, Georgia, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Active Not Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Active Not Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Active Not Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Active Not Recruiting |
| Washington University St. Louis | St Louis, Missouri, United States | Withdrawn |
| University of Rochester | Rochester, New York, United States | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04380740