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This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | For patients in the intervention group, the daGOAT model will be used to predict the occurrence of severe acute GvHD from day 17 to day 23 after transplantation. Each subject will be stratified into low-, intermediate-, and high-risk groups, and corresponding preventive interventions were implemented according to their risk levels. |
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| Control group | No Intervention | For patients in the control group, they will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe aGVHD during 100 days after transplantation according to the MAGIC criteria | Incidence of severe aGVHD after transplantation within 100 days. The medical records for each case wil be reviewed by two or three physicians to confirm the aGVHD diagnosis and grading (according to the MAGIC criteria) | 100 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Severe aGVHD during 180 days after transplantation according to the MAGIC criteria | 180 days after transplantation | |
| aGVHD in various target organs according to the MAGIC criteria | 180 days after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahui Feng | Contact | 022-23608045 | fengyahui@ihcams.ac.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2026 | Apr 22, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Overall survival | 1.5 year after transplantation |
| Relapse-free survival rate | 1.5 year after transplantation |
| Relapse rate | 1.5 year after transplantation |