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To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group of daGOAT model prevention | Experimental | Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection | Drug | Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation | 100 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation | 100 days after transplantation | |
| Engraftment rate | 180 days after transplantation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie jiang | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn | |
| yigeng cao | Contact | +86-18622477066 | caoyigeng@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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|
| Disease relapse rate |
| 180 days after transplantation |
| Infection rate | 180 days after transplantation |
| Overall survival | 180 days after transplantation |
| Non-relapse mortality | 180 days after transplantation |
| GVHD-free relapse-free survival | 180 days after transplantation |
| Overall Response Rate of severe aGVHD treatment | 100 days after transplantation |
| Incidence of chronic GVHD | 180 days after transplantation |
| Adverse events | 180 days after transplantation |
| Total cost of treatment | 180 days after transplantation |