Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

Summary

Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.

Timeline

Start

2017-03-10

Primary completion

2019-06-24

Completion

2021-04-23

Publications

• Mahmoudjafari Z, Bhatt V, Xue Z, Locatelli F, Socie G, Zeiser R. Clinical considerations for ruxolitinib in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) and steroid-refractory or -dependent chronic GVHD: a plain language summary. Ther Adv Hematol. 2026 May 19;17:20406207261442908. doi: 10.1177/20406207261442908. eCollection 2026.
• Mohty M, Socie G, Szer J, Niederwieser D, Butler J, Wagner-Drouet E, Or R, Rovenvald-Zuckerman T, Bozdag SC, Forcade E, Grillo G, Kroger N, Stolzel F, Russo D, Sanz J, Sarkar R, Stefanelli T, Wilke C, Zeiser R, von Bubnoff N. Ruxolitinib Versus Best Available Therapy in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease: Final Analysis From the Randomized Phase III REACH2 Trial. J Clin Oncol. 2025 Dec;43(34):3639-3645. doi: 10.1200/JCO-25-00809. Epub 2025 Oct 15.
• Mahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212.
• Socie G, Niederwieser D, von Bubnoff N, Mohty M, Szer J, Or R, Garrett J, Prahallad A, Wilke C, Zeiser R. Prognostic value of blood biomarkers in steroid-refractory or steroid-dependent acute graft-versus-host disease: a REACH2 analysis. Blood. 2023 Jun 1;141(22):2771-2779. doi: 10.1182/blood.2022018579.
• Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socie G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.
• Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

Drugs

Indications