Efficacy and Safety of Gecacitinib Hydrochloride in Prophylaxis Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis

Summary

Gecacitinib hydrochloride is a novel JAK/ACVR1 inhibitor approved for intermediate- and high-risk myelofibrosis (MF). Clinical and real-world data demonstrate significant efficacy in spleen reduction, symptom relief, and anemia improvement, with favorable safety and tolerability. Preclinical studies confirm that this agent can mitigate GVHD and suppress inflammation. MF patients undergoing allo-HSCT are at risk of delayed engraftment and aGVHD. Based on the immunomodulatory effects of JAK inhibitors, gecacitinib is expected to have potential for aGVHD prophylaxis. This study aims to evaluate the efficacy and safety of geltrectinib hydrochloride combined with ATG for preventing aGVHD in MF patients after allo-HSCT.

Timeline

Start

2026-03-01

Primary completion

2029-09-01

Completion

2029-12-01

Publications

• Results Saad A, de Lima M, Anand S, Bhatt VR, Bookout R, Chen G, Couriel D, Di Stasi A, El-Jawahri A, Giralt S, Gutman J, Ho V, Horwitz M, Hsu J, Juckett M, Kharfan-Dabaja MA, Loren A, Meade J, Mielcarek M, Moreira J, Nakamura R, Nieto Y, Roddy J, Satyanarayana G, Schroeder M, Tan CR, Tzachanis D, Burn J, Pluchino L. Hematopoietic Cell Transplantation, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020 May 1;18(5):599-634. doi: 10.6004/jnccn.2020.0021.
• Results Zhang Y, Zhou H, Zhuang J, et al. A randomized, double-blind, phase 3 study of jaktinib versus hydroxyurea (HU) in patients (pts) with intermediate-2 or high-risk myelofibrosis (MF). Journal of Clinical Oncology 41, no. 16_suppl (2023): 7015-7015.
• Results De Togni E, Cole O, Abboud R. Janus kinase inhibition in the treatment and prevention of graft-versus-host disease. Front Immunol. 2024 Feb 6;15:1304065. doi: 10.3389/fimmu.2024.1304065. eCollection 2024.

Drugs

Indications