Acute Graft-versus-Host Disease
Conditions
Interventions
Experimental group:Tirzepatide Combined with Standard GVHD Prophylaxis
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 6 months. 6. Basic organ functions are basically normal, and meet the following requirements: liver function: total bilirubin (TBIL) = 60 mL/(min·1.73m^2); cardiac function: left ventricular ejection fraction (LVEF) >= 50%, no severe arrhythmia, heart failure, etc. severe cardiac diseases; pulmonary function: forced expiratory volume in one second (FEV1) >= 60% predicted value. 7. Understand the purpose and process of this clinical trial, voluntarily sign the informed consent form, and be willing to cooperate in completing the entire trial period of treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Has received allo-HSCT treatment before. 2. Has severe infections that are uncontrolled (such as sepsis, active tuberculosis, active viral infections such as EBV active infection, CMV pneumonia, etc.). 3. Has congenital or acquired immune deficiencies (such as common variant immune deficiency, HIV infection, organ transplantation). 4. Has a history of drug allergy or contraindication related to trial medications such as telipropide, cyclosporine A, methotrexate, mycophenolate mofetil, etc. 5. Has severe or poorly controlled endocrine diseases, including: 1) Diabetes: all patients with type 1 diabetes; or type 2 diabetes patients with uncontrolled hyperglycemia (defined as fasting blood glucose >= 11.1 mmol/L or glycated hemoglobin >= 8.0%); or current and within 6 months before screening have experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state; or accompanied by severe chronic complications of diabetes (such as proliferative retinopathy, severe kidney disease estimated glomerular filtration rate = 160 mmHg and/or diastolic blood pressure >= 100 mmHg; or any level of hypertension accompanied by related hypertensive emergencies or severe complications, such as hypertensive encephalopathy, cerebral hemorrhage, heart failure, aortic dissection, unstable angina pectoris or acute myocardial infarction, etc.). 8. Risk of thyroid C-cell tumors: elevated serum calcitonin levels; personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenoma disease type 2 (MEN 2). 9. Has active or untreated malignant tumor history, or clinical significant malignant tumor remission less than 5 years. However, the following situations are excluded: basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate carcinoma in situ. 10. Risk of pancreatic diseases: history of acute/chronic pancreatitis, or at high risk (such as triglycerides > 500 mg/dL). 11. Recent specific treatment history: within 4 months before the first study administration, received T-cell depletion antibody therapy other than ATG (i.e., Fresenius ATG or thymoglobulin). 12. Has previously used glucagon-like peptide-1 receptor agonist drugs, such as semaglutide, telipropide. 13. Vaccinated with live vaccines within the past month. 14. Has mental illness or cognitive impairment, unable to understand and coo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of grade II-IV aGVHD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Neutrophil Engraftment;Incidence of Infection Events;Tirzepatide Plasma Concentration;Cumulative incidence of grade III-IV aGVHD;Non-Relapse Mortality (NRM);Dynamics of Regulatory T Cells (Treg) and Th17 Cells;Time to Platelet Engraftmen;Glucocorticoid Use;Treatment-Emergent Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Jian
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed