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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
SHR0302 po QD
Prednisone 1mg/kg/d po
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Xianmin Song
Shanghai, Shanghai Municipality, China
Safety and tolerability of SHR0302 and prednisone
The severity of adverse events is determined according to the CTCAE V5.0 criteria.
Time frame: After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone.
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)
Time frame: Within 4 weeks
Overall response rate (ORR) at week 24
Response rate at week 24 (the proportion of responders \[CR or PR\]) as defined by the NIH Consensus Development Project (2014)
Time frame: Within 24 weeks
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