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NOT YET RECRUITING
NCT07440654
NA

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Gecacitinib Hydrochloride Combined With Rabbit Anti-Human Thymocyte Immunoglobulin (ATG) in Prophylaxis Acute Graft-Versus-Host Disease (aGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) in Patients With Myelofibrosis (MF)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2029-12-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Gecacitinib

(i) Rabbit anti-human thymocyte immunoglobulin (ATG): administered on Days -4 to -2.(ii) Cyclosporine A: initiated on Day -9 through Day +180, tapered gradually after Day +90.(iii) Mycophenolate mofetil (MMF): administered at 0.5 g twice daily (bid) from Day -9 to Day +30.(iv) Geltrectinib hydrochloride: administered between Day +6 and Day +28 post-engraftment at a dose of 50 mg twice daily (bid).