steroid-refractory aGVHD
Conditions
Interventions
Group of CD25 Ab:CD25 monoclonal antibody
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 0–18 years, regardless of gender; 2. Undergoing allogeneic hematopoietic stem cell transplantation; 3. Diagnosed with glucocorticoid-resistant aGVHD according to the "Chinese Expert Consensus on Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Diseases (III) — Acute Graft-versus-Host Disease (2024 Edition)"; 4. The guardian of the subject fully understands the clinical trial protocol, agrees to participate in the trial, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe cardiovascular and cerebrovascular diseases: patients with heart function classified as grade 3 or below;those with a history of coronary heart disease, cerebral thrombosis, or cerebral arteriosclerosis; 2. Patients showing signs of relapse through bone marrow morphology, genetic testing, or immunological examination;or patients with malignant tumors whom doctors judge are at risk of relapse within the next 100 days. 3. Severe liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN), or total bilirubin (TBIL) >5 times ULN, or prothrombin activity (PTA) 3 times ULN; 4. Patients with severe organ failure, ECOG score greater than 2; 5. Patients with severe infections, CMV viremia, or positive plasma EBV; 6. Any other conditions deemed by the investigator to make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum drug concentration of CD25 Ab; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic GVHD rate;Outcome of Acute GVHD; | — |
Countries
China
Contacts
Public ContactWenyu Yang
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed