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This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 Tablets | Experimental | TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 tablets | Drug | Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) at 24 weeks | Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR). | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best objective response rate (BOR) | Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD | Up to 48 weeks |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, PhD | Contact | 13605714822 | hehuangyu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
| Up to 48 weeks |
| Failure-free survival (FFS) | The time from the first dose to the time of recurrence, death, or death or increase in non-original disease or initiation of a new cGVHD systemic | Up to 48 weeks |
| Incidence rate of malignancy relapse or recurrence | Proportion of subjects with recurrence date of blood system disease from the first dose | Up to 48 weeks |
| Non relapse mortality | From first dose to the date of death, with no recurrence of the original disease | At least 48 weeks |
| Overall Survival (OS) | Time from first dose to death caused by various reasons | At least 48 weeks |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) , evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | Up to 48 weeks |
| Severity of adverse events (AEs) | Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | Up to 48 weeks |
| The 940th hospital of joint logistics support force of Chinese people's liberation army | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510180 | 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 Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441021 | China |
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| Tai'an Central Hospital | Not yet recruiting | Taian | Shangdong | China |
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| Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shannxi | 710299 | China |
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| Hematology Hospital of the Chinese Academy of Medical Sciences | Not yet recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The Affiliated People's Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315040 | China |
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| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |