Trials / Not Yet Recruiting
Not Yet RecruitingNCT07440654
Efficacy and Safety of Gecacitinib Hydrochloride in Prophylaxis Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis
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)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2029-09-01
- Completion
- 2029-12-01
- First posted
- 2026-02-27
- Last updated
- 2026-02-27
Source: ClinicalTrials.gov record NCT07440654. Inclusion in this directory is not an endorsement.