Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease
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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
182 participants
Nov 20, 2024
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria12
- 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;
- Random failure of allogeneic hematopoietic stem cell transplantation within the first 6 months or having received 2 allogeneic hematopoietic stem cell transplants in the past;
- Used JAK inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, etc. within the first 2 weeks of randomization;
- There are multiple factors that can affect oral medication, such as inability to swallow, intestinal obstruction, etc;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrolled illnesses;
- Individuals who are allergic to research drugs or their components;
- Participated in other clinical trials within the first 4 weeks of randomization;
- According to the researcher's judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are deemed unsuitable for inclusion due to other reasons.
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Interventions
Rovadicitinib 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 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 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.
Metoprolol ester is an organic compound mainly used as an immunosuppressant
Rituximab 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.
Locations(41)
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NCT06682169