shr0302 and steroid as first line therapy for chronic gvhd

Conditions: Chronic GVHD

Summary: 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.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old and ≤ 70 years old, male or female; * patients receiving allogeneic peripheral blood stem cell transplantation for hematological diseases; * the primary hematological malignancies are completely relieved and are expected to be stable for at least 3 months; * chronic gvhd that was first attacked after transplantation and at least 100 days after transplantation, reached a moderate or severe level by nih classification; * there was no previous systemic treatment (including in vitro illumination \[ecp\]); * the patient may be receiving other immunosuppressive agents to prevent or treat acute gvhd, but if the subject receives prednisone to prevent or treat acute gvhd, it must be \<0.5 mg/kg/d or equivalent dose of other glucocorticoids; * the chronic gvhd that has started hormone therapy does not exceed 72 hours; * karnofsky score \> 60 points; * patients must be able to understand and are willing to participate in the study and sign an informed consent form. exclusion criteria: * can not tolerate prednisone dose 1mg / kg / d or equivalent dose of other glucocorticoids for the treatment of cgvhd; * receive any systemic treatment of cgvhd, except for corticosteroids that treat cgvhd within 72 hours prior to the signing of informed consent; * patients with gvhd overlap syndrome (nih criteria); * treatment of acute gvhd has received other jak inhibitors such as ruxolitinib; * pregnant or lactating women; * the patient is judged by the investigator to have complications that may cause other risks; * the patient is receiving other study medications; * patient blood routine: anc \<1.0 × 109 / l or plt \< 50 × 109 / l; * non-gvhd-related liver damage: the aspartate aminotransferase (ast)/alanine aminotransferase (alt) ratio is more than 3 times normal or the direct bilirubin normal value is more than 3 times; * renal dysfunction: endogenous creatinine clearance (ccr) \< 50ml/min or normal serum creatinine 1.5 times or more, regardless of hemodialysis treatment; * uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever without symptoms or signs and cannot be ruled out infected person * people living with hiv; * active hepatitis b (hbv), active hepatitis c (hcv) requires antiviral therapy; patients with hbv activation risk refer to patients with hepatitis b surface antigen-positive or core antibody-positive patients who are not treated with anti-hbv; * the patient's primary malignant disease recurs and the graft is rejected; * those who are allergic to known jak inhibitors.