Graft-versus-Host Disease after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
experimental group:Ruxolitinib combined with Sirolimus
control group:ciclosporin or tacrolimus
Sponsors
Sichuan Provincial People's Hospital, Affliated Hospital of University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient criteria: (1) Patients after allogeneic hematopoietic stem cell transplantation; (2) Aged >= 18 years; (3) Karnofsky score >= 60; (4) Serum total bilirubin= 30ml/min ( Calculate or measure through 24-hour urine collection); (5) Life expectancy >= 3 months; 2. Sign a written informed consent form before trial screening.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 2. There is currently active GVHD; 3. Patients with a history of prolonged QTc interval of clinical significance (male> 450ms, female> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year , Congestive heart failure (CHF), patients with coronary heart disease who have symptoms and require medication; 4. Cardiac B-ultrasound shows patients whose pericardial cavity liquid dark zone width >=10mm at the end of diastole; 5. Patients with active bleeding; 6. Patients with diseases or history of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, etc.; 7. Those with active infection, or those who continue to have a fever within 14 days before enrollment; 8. Those with active infection of HBV, HCV and HIV; 9. Those who are less than 6 weeks after the main organ surgery; 10. Patients who take drugs or long-term alcohol abuse that affect the evaluation of the test results; 11. The researcher judges that it is not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of GVHD;incidence of thrombotic microangiopathy;Cumulative recurrence rate at 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Overall survival at 2 years;non-relapse mortality; | — |
Countries
China
Contacts
Public ContactHuang Xiaobing
Sichuan Provincial People's Hospital, Affliated Hospital of University of Electronic Science and Technology of China
Outcome results
None listed