{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T06:43:22Z","timestamp":1784357002045,"version":"3.55.0"},"reference-count":21,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,4,5]],"date-time":"2022-04-05T00:00:00Z","timestamp":1649116800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This single\u2010arm, multicentre, phase I study is the first study of zanubrutinib, a potent, specific, irreversible Bruton tyrosine kinase (BTK) inhibitor, in Chinese patients with relapsed\/refractory B\u2010cell malignancies. The objectives were to evaluate safety and preliminary anti\u2010tumour activity. Forty\u2010four patients received zanubrutinib 320\u00a0mg once daily (QD) (<jats:italic>n<\/jats:italic>\u00a0=\u00a010) or 160\u00a0mg twice daily (BID) (<jats:italic>n<\/jats:italic>\u00a0=\u00a034) until disease progression or unacceptable toxicity. 29.5% of patients received zanubrutinib for at least two\u00a0years. The most common adverse event (AE) and the most common grade\u00a03 or higher AE was neutrophil count decreased (54.5% and 25.0% respectively). Two patients (4.5%) discontinued treatment due to AEs and one treatment\u2010emergent AE led to death. All haemorrhagic events were grade 1\u20132 (except for one non\u2010serious grade 3 purpura). No second primary malignancies, tumour lysis syndrome, or atrial fibrillation\/flutter occurred. The overall response rate was 52.3% (complete response rate, 18.2%). Patients with all cancer subtypes benefited from treatment. <jats:italic>BTK<\/jats:italic> C481S\/R or L528W mutations were found in zanubrutinib\u2010progressive patients. The safety\/efficacy profiles of patients treated with 320\u00a0mg QD and 160\u00a0mg BID were comparable and similar daily area under the curve (AUC) was achieved. Overall, zanubrutinib was well tolerated and either of these two regimens is clinically practical. Registered at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> (NCT03189524, on 16 June 2017, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03189524\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03189524<\/jats:ext-link>).<\/jats:p>","DOI":"10.1111\/bjh.18162","type":"journal-article","created":{"date-parts":[[2022,4,5]],"date-time":"2022-04-05T12:25:13Z","timestamp":1649161513000},"page":"62-72","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["A two\u2010part, single\u2010arm, multicentre, phase I study of zanubrutinib, a selective <scp>Bruton tyrosine kinase<\/scp> inhibitor, in Chinese patients with relapsed\/refractory B\u2010cell malignancies"],"prefix":"10.1111","volume":"198","author":[{"given":"Yuqin","family":"Song","sequence":"first","affiliation":[{"name":"Department of Lymphoma Key laboratory of Carcinogenesis and Translational Research (Ministry of Education) Peking University Cancer Hospital &amp; Institute  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingyuan","family":"Sun","sequence":"additional","affiliation":[{"name":"National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital &amp; Institute of Hematology Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junyuan","family":"Qi","sequence":"additional","affiliation":[{"name":"National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital &amp; Institute of Hematology Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Hematology The First Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1332-9230","authenticated-orcid":false,"given":"Jianfeng","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Hematology Tongji Hospital Tongji Medical College  Wuhan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dengju","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hematology Tongji Hospital Tongji Medical College  Wuhan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianyong","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hematology The First Affiliated Hospital of Nanjing Medical University Jiangsu Province Hospital  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lugui","family":"Qiu","sequence":"additional","affiliation":[{"name":"National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital &amp; Institute of Hematology Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenmu","family":"Du","sequence":"additional","affiliation":[{"name":"BeiGene (Beijing) Co., Ltd.  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