Acute Graft-versus-Host Disease
Conditions
Brief 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).
Interventions
DRUGRecombinant 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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 16 years, regardless of gender. 2. Patients with hematologic disorders who are scheduled to receive allo-HSCT. 3. Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Exclusion criteria
1. Patients who have received a second or multiple transplants. 2. Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection. 3. Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation | 100 days after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Engraftment rate | 180 days after transplantation |
| 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 |
| Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation | 100 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 |
| GVHD-free relapse-free survival | 180 days after transplantation |
Countries
China
Contacts
Primary Contacterlie jiang
Backup Contactyigeng cao
Outcome results
None listed