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).
Age ≥ 16 years, regardless of gender.
Patients with hematologic disorders who are scheduled to receive allo-HSCT.
Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Patients who have received a second or multiple transplants.
Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.
Single group
Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection
DrugModel-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.
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation
Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation
Engraftment rate
Disease relapse rate
Infection rate
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