NCT07381114

A Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing aGVHD After HLA-matched Transplantation

Phase II Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing Acute Graft-versus-host Disease After HLA-matched Transplantation

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.

Detailed description

This project is a prospective, single-arm clinical study. It aims to apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in patients with hematological malignancies undergoing HLA-mismatched transplantation. The primary objective is to observe the incidence of grade II-IV aGVHD after transplantation prevention. The secondary objectives include the incidence of primary graft failure, graft-versus-host disease-free and relapse-free survival (GRFS) at 12 months, the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) within 100 days to 1 year, treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety assessment of the prevention regimen. This study is intended to provide a reference for the clinical application of Ivarmacitinib in transplantation. Therefore, this research is proposed to be conducted.

Conditions

• aGVHD

Interventions

Type	Name	Description
DRUG	Ivarmacitinib	Patients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days.

Timeline

• Start date: 2026-02-14
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2026-02-02
• Last updated: 2026-02-02