Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

Condition(s) studied

Investigational drug(s) / intervention(s)

Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection: 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.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation — 100 days after transplantation

Trial sites (1)

More Institute of Hematology & Blood Diseases Hospital, China trials in China

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