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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivarmacitinib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of grade II-IV aGVHD | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of primary graft failure | up to 2 years | |
| the event-free survival (GRFS) without GVHD (12 months) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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