Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital