A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
erlie jiang
jiangerlie@ihcams.ac.cn
+86-15122538106
Backup
yigeng cao
caoyigeng@ihcams.ac.cn
+86-18622477066
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 174
Treatments
Experimental: The group of daGOAT model prevention
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.
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China