Acute leukemia, myelodysplastic syndromes, and severe aplastic anemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age:? 18 to 65 years, inclusive. 2.Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for hematologic diseases. 3.Karnofsky Performance Status (KPS) score = 70%. 4.Written informed consent obtained from both the patient and the donor.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled severe infection. 2.Severe hepatic or renal dysfunction, or cardiopulmonary insufficiency. 3.Active thrombosis. 4.Any concomitant medical condition that, in the investigator's judgment, would compromise patient safety or significantly interfere with the patient's ability to complete the study. 5.Known hypersensitivity or contraindication to the investigational product (active ingredient and/or excipients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood Treg cell percentage and absolute count on day 30 post-transplantation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of GVHD;Time to Platelet Engraftment;NK cell functional maturity;Infectious events;T cell subset reconstitution;Cytokines and biomarkers;Survival outcomes; | — |
Countries
China
Contacts
Qilu Hospital of Shandong University