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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07381114
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivarmacitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 14, 2026
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Ivarmacitinib
    During the dose exploration phase, the "3+3" method was used for Ivarmacitinib, with the dose incrementing from 2mg to 6mg. The medication was administered starting from -3 days and observation continued until 28 days after transplantation to determine the RP2D dose. 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.

Primary Outcome Measure

incidence of grade II-IV aGVHD [ Time Frame: up to 2 years ]

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