Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
Location status: Recruiting
Recruiting
NCT Number: NCT06880419
Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
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.
Primary outcomes
-
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation
Time frame: 100 days after transplantation
Secondary outcomes
-
Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation
Time frame: 100 days after transplantation
-
Engraftment rate
Time frame: 180 days after transplantation
-
Disease relapse rate
Time frame: 180 days after transplantation
-
Infection rate
Time frame: 180 days after transplantation
-
Overall survival
Time frame: 180 days after transplantation
-
Non-relapse mortality
Time frame: 180 days after transplantation
-
GVHD-free relapse-free survival
Time frame: 180 days after transplantation
-
Overall Response Rate of severe aGVHD treatment
Time frame: 100 days after transplantation
-
Incidence of chronic GVHD
Time frame: 180 days after transplantation
-
Adverse events
Time frame: 180 days after transplantation
-
Total cost of treatment
Time frame: 180 days after transplantation
Study contacts
Contact information is provided by the study sponsor or research team.
erlie jiang
CONTACT
yigeng cao
CONTACT
Sponsors and collaborators
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Other
Registry information
Official study title
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
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Mar 17, 2025
- Registry last updated
- Aug 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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