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This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 Tablet | Experimental | TQ05105 tablet 10mg given orally, twice daily in 28-cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 Tablet | Drug | TQ05105 tablet is a Janus Kinase (JAK) inhibitor, which can inhibit the abnormal activation of JAK 2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK / STAT pathway. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Tolerable Dose (MTD) | If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. (Patients in phase Ib) | Baseline up to 4 weeks |
| Recommended phase II dose (RP2D) | Recommended dose for phase II (Patients in phase Ib) | Baseline up to 4 weeks |
| Best Overall Response Rate (BOR) | Percentage of participants achieving complete response (CR) and partial response (PR). (Patients in phase II) | Baseline up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR) during the study according to the cGVHD NIH Consensus Criteria. | Baseline up to 52 weeks |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Hefei | Anhui | 230001 | China | ||
| Zhujiang Hospital of Southern Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009501 | Derived | Zhao YM, Luo Y, Shi JM, Wang SQ, Wang CK, Jiang EL, Liang C, Zhu XY, Zhang XJ, Meng FK, Jin H, Zhao YQ, Yu J, Lai XY, Liu LZ, Fu HR, Ye YS, Zhang CX, Wang T, Tu LF, Wang XQ, Huang H. A first-in-class JAK/ROCK inhibitor, rovadicitinib, for glucocorticoid-refractory or -dependent chronic GVHD. Blood. 2025 Jun 12;145(24):2857-2872. doi: 10.1182/blood.2024026581. |
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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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DOR defined as time from earliest date of disease response to earliest date of disease progression.
| Baseline up to 96 weeks |
| Overall survival (OS) | OS defined as the time from randomization to the time of death from any cause. | Baseline up to death event, up to 5 years. |
| Non-relapse mortality (NRM) | Defined as the date of first dose to the date of death from non hematologic disease recurrence / progression | Baseline up to 96 weeks |
| Failure Free Survival (FFS) | Defined as absence of relapse, death, or need for additional systemic immunosuppressant cGVHD therapy. | Baseline up to 12 months |
| Changes in glucocorticoid dose | The reduction in glucocorticoid requirement would be regarded as an effect of the trial drug. | Baseline up to 96 weeks |
| Changes in symptom burden | Evaluate changes in symptom burden as measured by the Lee Symptom Scale. A change of 7 points on the Lee Symptom Scale will be considered clinically significant and relates to improvement in quality of life. | Baseline up to 96 weeks |
| Maximum plasma concentration (Cmax) | Cmax is the maximum plasma concentration of TQ05105 or its metabolite(s). | Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. |
| Time to reach maximum plasma concentration (Tmax) | To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration. | Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. |
| Area under the plasma concentration time curve (AUC0-t) | To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity. | Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. |
| Incidence rate of adverse event | The occurrence rate of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) assessed based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | Baseline up to 96 weeks. |
| Guangzhou |
| Guangdong |
| 510280 |
| China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 511457 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Tongji Hospital Tongji Medical College of HUST | Wuhan | Hubei | 430030 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hanzhou | Zhejiang | 310000 | China |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |