A Randomized, Open Label, Positive Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of the Selected Regimen of Rovadicitinib in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond
The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.
• Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 6 months;
• Previously received allogeneic hematopoietic stem cell transplantation;
• According to NIH standards, the clinical diagnosis is moderate to severe cGVHD；
• Previously received systematic treatment for cGVHD with 2-5 lines;
• Stable dosage of corticosteroids and other immunosuppressants received within 2 weeks prior to screening;
• The main organ functions well;
• Starting from Day 1 after enrollment in the control group of this study, participants must receive one of the drugs specified in the study protocol;
• Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study; Serum pregnancy test negative within 7 days prior to enrollment in the study, and must be a non lactating subject; Male participants should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
• Subjects voluntarily joined this study, signed informed consent, and had good compliance.