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This is single\u2010arm, multi\u2010center, open\u2010label, phase 2 study in 80 eligible Chinese patients, who were treated with monotherapy of orelabrutinib at 150\u2009mg once daily. Overall response rate evaluated by an independent review committee was the primary endpoint, and secondary endpoints include progression\u2010free survival, overall survival, and safety. Independent review committee assessed overall response rate was 92.5% (74\/80); complete response 21.3% (17\/80), partial response 60.0% (48\/80), partial response with lymphocytosis 11.3% (9\/80). At a 32.3\u2010month median follow\u2010up, the median progression\u2010free survival had not been achieved, while the 30\u2010month progression\u2010free survival rate and overall survival rates were 70.9% (95% confidence interval [CI], 59.5\u201379.6) and 81.3% (95% CI, 70.8\u201388.2), respectively. Orelabrutinib also revealed substantial response in patients with high prognostic risks: overall response rates of patients carrying positive <jats:italic>TP53<\/jats:italic> mutational status or del(17p), del(11q), as well as unmutated immunoglobulin heavy\u2010chain variable region gene were 100%, 94.7%, and 93.9%, respectively. Most adverse events were in low grade, with 86.8% of AEs being Grade 1 or 2. Nearly 67% of patients were still receiving orelabrutinib after almost a 3\u2010year follow\u2010up. In conclusion, Orelabrutinib demonstrated compelling efficacy as well as safety profiles, with a noteworthy number of patients obtaining complete response in refractory or relapsed CLL\/SLL.<\/jats:p>","DOI":"10.1002\/ajh.26826","type":"journal-article","created":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T07:53:26Z","timestamp":1674460406000},"page":"571-579","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia\/small lymphocytic lymphoma patients: Multi\u2010center, single\u2010arm, open\u2010label, phase 2 study"],"prefix":"10.1002","volume":"98","author":[{"given":"Wei","family":"Xu","sequence":"first","affiliation":[{"name":"Department of Hematology, Pukou CLL Center, The First Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine  Nanjing People's 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