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

NCT07440654 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • aGVHD Prophylaxis

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).

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-09-01
Completion
2029-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440654 on ClinicalTrials.gov