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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rovadicitinib | Experimental | Rovadicitinib: 10mg, taken orally on an empty stomach twice a day, with a minimum interval of 8 hours between each dose, and an optimal interval of 12 hours. Every 28 days is a treatment cycle. |
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| Imatinib or Methotrexate or Mycophenolate or Rituximab | Active Comparator | Methotrexate tablets: 10mg, orally, once a week or 5mg, orally, twice a week. Metoprolol ester: 250mg-500mg, bid, orally. Imatinib: 100-400mg, qd, oral. Rituximab: 375mg/m2, administered intravenously once a week for 4 consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rovadicitinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Objective Response Rate (BOR) | The best therapeutic effect among all therapeutic outcomes | Week 24 |
| Duration of Relief (DOR) | The duration of symptom relief for patients after receiving treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, Doctor | Contact | 13605714822 | hehuangyu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| Imatinib | Drug | 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. |
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| Methotrexate | Drug | 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. |
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| Mycophenolate mofetil | Drug | Metoprolol ester is an organic compound mainly used as an immunosuppressant |
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| Rituximab | Drug | 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. |
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| Through study completion, an average of 2 year |
| 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. | Week 24 |
| 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 | Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96 |
| Primary disease recurrence rate (MR) | The probability of recurrence of the patient's disease within a certain period of time. | Weeks 8, 16,24, 36, 48 |
| Non-Relapse Mortality (NRM) | NRM was defined as death without recurrent or progressive disease | Weeks 8, 16,24, 36, 48 |
| Overall survival (OS) | From randomization to the time of death caused by any reason | Through study completion, an average of 2 year |
| Percentage of subjects whose daily glucocorticoid dose decreased | Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids | Week 24 |
| Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√" | Through study completion, an average of 2 year |
| Changes in 5-level EQ-5D (EQ-5D-5L) | The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty) | Through study completion, an average of 2 year |
| Adverse events (AE) | The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators. | Through study completion, an average of 2 year |
| Cmax | The maximum concentration of medication that enters the bloodstream after administration | Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle) |
| Ctrough | After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration | Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle) |
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| The Southwest Hospital of AMU | Not yet recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361003 | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510180 | China |
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| Nanfang Hospital | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| The Affiliated Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | 550001 | China |
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| The Second Hospital of Hebei Medical Hospital | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The Third People's Hospital of Zhengzhou | Not yet recruiting | Zhengzhou | Henan | 450099 | China |
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| Henan Cancer Hospital | Recruiting | Zhenzhou | Henan | 450000 | China |
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| Wuhan Union Hospital of China | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430071 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | Hunan | China |
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| Huai'an Second People's Hospital | Not yet recruiting | Huai'an | Jiangsu | 223200 | China |
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| Zhongda Hospital Southeast University | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130031 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
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| Tai'an City Central Hospital | Not yet recruiting | Tai’an | Shandong | 271000 | China |
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| Shanghai Jiao Tong University School of Medicine,Renji Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200001 | China |
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| Ruijin Hospital, Shanghai Jiaotong University School Of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
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| Shanxi Provincial People's Hospital | Not yet recruiting | Xi’an | Shanxi | 710068 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| Chinese Academy of Medical Sciences Hematology Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| The First Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830054 | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| The Affiliated People's Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315040 | China |
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| The First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315211 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325005 | China |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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