{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T12:08:58Z","timestamp":1783944538585,"version":"3.55.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T00:00:00Z","timestamp":1726272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T00:00:00Z","timestamp":1726272000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Hematol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Acalabrutinib is a highly selective Bruton tyrosine kinase inhibitor approved in the United States and Europe for chronic lymphocytic leukemia (CLL) based on phase 3 trials with limited representation of Asian populations. This phase 1\/2 trial evaluates acalabrutinib in Chinese adults with relapsed\/refractory (R\/R) CLL receiving acalabrutinib 100\u00a0mg twice daily in 28-day cycles until disease progression or treatment discontinuation due to adverse events (AEs) presenting substantial clinical risk. The primary endpoint was blinded independent central review (BICR)-assessed overall response rate (ORR). A total of 60 patients from 20 sites in China received acalabrutinib (median age 62\u00a0years; median 1 prior therapy line; 21.7% with del(17p) and\/or <jats:italic>TP53<\/jats:italic> mutation; 51.7% with unmutated IGHV). Median total treatment duration was 19.4\u00a0months (range 0.6\u201328.2) with 53 patients (88.3%) receiving acalabrutinib at data cutoff; median study follow-up was 20.2\u00a0months. BICR-assessed ORR was 85.0% (95% CI, 73.4\u201392.9). Median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached. Estimated 12-month and 18-month PFS rates were 91.5% (95% CI, 80.9\u201396.4) and 78.8% (95% CI, 60.9\u201389.2); OS rates were both 96.7% (95% CI, 87.3\u201399.2). AEs of grade\u2009\u2265\u20093 occurred in 25 patients (41.7%), most commonly decreased neutrophil count (13.3%, n\u2009=\u20098), pneumonia (6.7%, n\u2009=\u20094), and upper respiratory tract infection (6.7%, n\u2009=\u20094). AEs led to treatment discontinuation in 2 patients (paraneoplastic pemphigus; rectal neoplasm). This study demonstrated high ORR in acalabrutinib-treated Chinese patients with R\/R CLL with no unexpected safety concerns. This trial is registered on ClinicalTrials.gov (NCT03932331).<\/jats:p>","DOI":"10.1007\/s00277-024-05978-4","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T02:01:55Z","timestamp":1726279315000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Acalabrutinib in Chinese patients with relapsed\/refractory chronic lymphocytic leukemia: Primary analysis from an open-label, multicenter phase 1\/2 trial"],"prefix":"10.1007","author":[{"given":"Shenmiao","family":"Yang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiwen","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keshu","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xielan","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanqiu","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindong","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yujie","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofeng","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianyong","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"issue":"suppl 5","key":"5978_CR1","doi-asserted-by":"publisher","first-page":"v78","DOI":"10.1093\/annonc\/mdv303","volume":"26","author":"B Eichhorst","year":"2015","unstructured":"Eichhorst B, Robak T, Montserrat E, Ghia P, Hillmen P, Hallek M, Buske C (2015) Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. 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The study was conducted according to the principles from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, and applicable International Conference on Harmonization Good Clinical Practice guidelines.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Shenmiao Yang: Nothing to disclose.Haiwen Huang: Nothing to disclose.Keshu Zhou: Nothing to disclose.Xielan Zhao: Nothing to disclose.Yanqiu Han: Nothing to disclose.Lindong Li: Employment: AstraZeneca.Yujie Wang: Employment: AstraZeneca.Xiaofeng Liu: Employment: AstraZeneca.Jianyong Li: Nothing to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}