Abatacept as GVHD Prophylaxis Phase 2

Summary

This is a phase II multi-center, randomized, double blind, placebo-controlled trial. The investigators are doing this study to see if a new drug, abatacept, can be used together with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.

Timeline

Start

2013-02-01

Primary completion

2018-06-30

Completion

2024-03-30

Outcome

Met primary endpoint

release “In the GVHD-1 trial, abatacept demonstrated improved severe (grade III-IV) aGvHD-free survival in 7/8 mismatched unrelated donor transplant and associated mortality” bms.com ↗

Publications

• Takahashi T, Watkins B, Bratrude B, Neuberg D, Hebert K, Betz K, Yu A, Choi SW, Davis J, Duncan C, Giller R, Grimley M, Harris AC, Jacobsohn D, Lalefar N, Farhadfar N, Pulsipher MA, Shenoy S, Petrovic A, Schultz KR, Yanik GA, Blazar BR, Horan JT, Langston A, Kean LS, Qayed M. The Adverse Event Landscape of Stem Cell Transplant: Evidence for AGVHD Driving Early Transplant Associated Toxicities. Transplant Cell Ther. 2025 Feb;31(2):109.e1-109.e13. doi: 10.1016/j.jtct.2024.03.030. Epub 2024 Apr 6.
• Takahashi T, Al-Kofahi M, Jaber M, Bratrude B, Betz K, Suessmuth Y, Yu A, Neuberg DS, Choi SW, Davis J, Duncan C, Giller R, Grimley M, Harris AC, Jacobsohn D, Lalefar N, Farhadfar N, Pulsipher MA, Shenoy S, Petrovic A, Schultz KR, Yanik GA, Blazar BR, Horan JT, Watkins B, Langston A, Qayed M, Kean LS. Higher abatacept exposure after transplant decreases acute GVHD risk without increasing adverse events. Blood. 2023 Aug 24;142(8):700-710. doi: 10.1182/blood.2023020035.

Drugs

Indications