Acute graft-versus-host disease (aGVHD)
Conditions
Interventions
Short-Course Sitagliptin group :Participants will receive sitagliptin phosphate 600 mg orally at 8:00 a.m. and 4:00 p.m. on Day –1 and Day 0 (the day before and the day of stem cell infusion), for a t
Long-Course Sitagliptin group:Participants will receive sitagliptin phosphate 600 mg orally at 8:00 a.m. and 4:00 p.m. from Day –1 to Day +3 (the day before stem cell infusion through Day +3), for a t
Sponsors
The First Affiliated Hospital of USTC
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of hematologic diseases (e.g., acute leukemia, myelodysplastic syndrome, aplastic anemia, lymphoma), aged 18-65 years, regardless of sex or race. 2. Candidates for first-time allogeneic peripheral blood stem cell transplantation (allo-PBSCT), including matched sibling donor transplantation (MSDT), matched unrelated donor transplantation (MUDT), or haplo-identical donor transplantation (HIDT). 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 4. No evidence of severe organ failure or active uncontrolled infection. 5. Voluntary participation in the study. 6. Written informed consent (ICF) must be obtained from each participant or their legally authorized representative, confirming understanding of the study objectives and procedures and willingness to participate.
Exclusion criteria
Exclusion criteria: 1. Severe organ dysfunction or disease, including but not limited to significant cardiac, hepatic, renal, or pulmonary impairment (e.g., leftventricular ejection fraction [LVEF] 3 × upper limit of normal [ULN], creatinine clearance <30 mL/min). 2. Active central nervous system (CNS) disease or leukemia with CNS involvement. 3. History of pancreatitis, symptomatic cholelithiasis, or diabetes requiring insulin secretagogues and/or insulin therapy. 4. Pregnant or breastfeeding women. 5. Any life-threatening illness, uncontrolled medical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise subject safety or place the study outcomes at undue risk; current substance abuse; uncontrolled psychiatric disorder; or cognitive impairment. 6. Known allergy or hypersensitivity to sitagliptin phosphate. 7. Participation in another interventional clinical trial that may affect the incidence of aGVHD within 3 months prior to enrollment. 8. Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation (e.g., inability to comply with study visits or treatment due to financial or logistical reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade II to IV aGVHD at 100 days after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade III to IV aGVHD at 100 days after transplantation;The cumulative incidence of neutrophil engraftment at 28 days after transplantation;The cumulative incidence of platelet recovery at 100 days after transplantation;The cumulative incidence of transplant-related mortality at 360 days after transplantation;The probability of overall survival(OS) at 360 days after transplantation;The probability of GVHD-free, relapse-free survival(GRFS) at 360 days after transplantation;The cumulative incidence of overall chronic GVHD at 360 days after transplantation; | — |
Countries
China
Contacts
Public ContactXiaoyu Zhu
The First Affiliated Hospital of USTC
Outcome results
None listed