[Translation] A single-arm, open-label, multicenter phase II clinical study evaluating the efficacy and safety of bezacitinib tablets in intermediate- to high-risk patients with myelofibrosis who are refractory, relapsed, or intolerant to JAK inhibitors.
主要目的:评价贝泽昔替尼片治疗JAK抑制剂难治/复发/不耐受中高危骨髓纤维化(MF)的脾脏体积缩小有效率
次要目的:评价贝泽昔替尼片治疗JAK抑制剂难治/复发/不耐受中高危MF的客观有效率、脾响应、MF相关症状改善等;评价贝泽昔替尼片治疗JAK抑制剂难治/复发/不耐受中高危MF的安全性。
[Translation] Primary objective: To evaluate the efficacy of bezacitinib tablets in reducing spleen volume in JAK inhibitor-refractory/relapsed/intolerant intermediate-to-high-risk myelofibrosis (MF). Secondary objectives: To evaluate the objective response, splenic response, and improvement of MF-related symptoms of bezacitinib tablets in JAK inhibitor-refractory/relapsed/intolerant intermediate-to-high-risk MF; and to evaluate the safety of bezacitinib tablets in treating JAK inhibitor-refractory/relapsed/intolerant intermediate-to-high-risk MF.