graft versus host disease
Conditions
Interventions
Experimental group:Ruxolitinib+CNI+MTX
Control group:None
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients must be diagnosed with malignant hematological disease; 2.Aged 12-70 years; 3.Received Hemicongruent allogeneic hematopoietic stem cell transplantation; 4.Pretreatment scheme: myeloablative pretreatment; 5.Karnofsky score >= 70; 6.Creatinine clearance >= 60 mL/min (according to the Cockcroft-Gault formula); 7.Liver and kidney function: aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) = 50% on echocardiography (ECHO); 9.Life expectancy >12 weeks; 10.Voluntarily signed the consent form and could understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.. 2.Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled. hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment. 3.Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes). 4.Human immunodeficiency virus (HIV) infection is known. 5.Cirrhosis of the liver, active hepatitis*. *Active hepatitis (hepatitis B reference: positive HBsAg with HBV DNA test value exceeding the upper limit of normal; Hepatitis C reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); Note: eligible subjects with positive surface antigen or core antibody for hepatitis B and hepatitis C should receive continuous antiviral therapy to prevent virus activation. 6.Pregnant or lactating women. 7.Patients who are concurrently enrolled in any clinical trials of similar drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Cumulative incidence of II-IV aGVHD at 100 days; | — |
Countries
China
Contacts
Public ContactHuang He
the First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed