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;
Has experienced or currently suffers from other malignant tumors within the past 3 years;
Known or suspected active aGVHD；
Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;
The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;
Parallel
Rovadicitinib
DrugRovadicitinib is an inhibitor of Janus associated kinases (JAK) family and Rho associated kinases (ROCK). It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated kinase 2 (ROCK2). The JAK 1-JAK 2 signaling pathway is a key step in causing inflammation and tissue damage in acute and chronic graft-versus-host disease.
Imatinib
DrugImatinib tyrosine kinase inhibitor is a small molecule protein kinase inhibitor that has the ability to block one or more protein kinases. Clinically used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors.
Methotrexate
DrugMethotrexate is an organic compound, mainly used as an anti folate anti-tumor drug. It inhibits the synthesis of tumor cells by inhibiting dihydrofolate reductase, thereby inhibiting the growth and reproduction of tumor cells.
Mycophenolate mofetil
DrugMetoprolol ester is an organic compound mainly used as an immunosuppressant
Rituximab
DrugRituximab activates antibody dependent cell-mediated phagocytosis and complement dependent cytotoxicity by binding to cluster of differentiation 20 (CD20) antigen, clearing malignant B cells expressing CD20 and achieving therapeutic goals.
Objective remission rate in the 24th week (ORR)
Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined.
Best Objective Response Rate (BOR)
The best therapeutic effect among all therapeutic outcomes
Duration of Relief (DOR)
The duration of symptom relief for patients after receiving treatment
Improvement in Lee cGVHD symptom score of subjects in week 24
The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms.
Failure free survival (FFS)
The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient
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