About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patients have been clearly diagnosed with hematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. The planned treatment for these patients is myeloablative or reduced-intensity conditioning, followed by HLA half-matched stem cell transplantation.
Has not received any systemic treatment, including extracorporeal photodynamic therapy (ECP)
KPS>60% or ECOG PS 0-2
Patients who have not received any other prophylactic immunosuppressive agents or aGVHD/cGVHD treatment are eligible
Disqualifiers
Pregnant women or women who are breastfeeding
Absolute Neutrophil Count (ANC) < 1.0 x 109/L or Platelet Count < 50 x 109/L
Uncontrolled active infections or active hepatitis B or hepatitis that requires antiviral treatment
Human Immunodeficiency Virus (HIV) positive
Trial design
Single group
Treatments tested in this trial
Ivarmacitinib
DrugPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
incidence of grade II-IV aGVHD
Secondary outcomes
the incidence of primary graft failure
the event-free survival (GRFS) without GVHD (12 months)
Locations
Sponsors and contacts
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