Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis — ABA3  

Graft Vs Host Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Graft Vs Host Disease

• NCT number: NCT04380740
• Study type: Interventional
• Source: Boston Children's Hospital
• Contact: Brandi M Bratrude, BA
• Phone: 6179192197
• Email: brandi.bratrude@childrens.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 30, 2022
• Completion date: April 2025