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The purpose of this study is to evaluate the efficacy of SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).
Treatment: Once patients are diagnosed with chronic GVHD, the combination therapy should be initiated as soon as possible. 1. Prednisone: 1mg/kg/d po. Taper steroid every two weeks according to patient's response. 2. SHR0302 QD po. for at least 28 days. Indication for stopping SHR0302 treatment: 1. No response after SHR0302 treatment for 12 weeks. 2. Develop life-threatening complication. 3. ANC<0.5×10e9/L or PLT< 30×10e9/L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy | Experimental | Experimental: combination therapy There is only 1 arm. Combination therapy arm includes SHR0302 and Prednisone Prednisone 1mg/kg/d po,At the same time give SHR0302 QDpo; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | SHR0302 po QD |
| |
| Prednisone |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SHR0302 and prednisone | The severity of adverse events is determined according to the CTCAE V5.0 criteria. | After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) at week 4 | Response rate at week 4 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014) | Within 4 weeks |
| Overall response rate (ORR) at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xianmin Song, M.D. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China | ||
| Xianmin Song |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38798038 | Derived | He Q, Sun X, Niu J, Yang J, Wang Y, Huang C, Zhou K, Tong Y, Cai Y, Dong B, Wan L, Song X, Qiu H. A Novel JAK1 Inhibitor SHR0302 Combined With Prednisone for First-Line Treatment of Chronic Graft-Versus-Host Disease: A Phase I Clinical Trial. Cell Transplant. 2024 Jan-Dec;33:9636897241254678. doi: 10.1177/09636897241254678. |
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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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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Prednisone 1mg/kg/d po |
|
Response rate at week 24 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014)
| Within 24 weeks |
| Shanghai |
| Shanghai Municipality |
| 200080 |
| China |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |