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We aimed to examine the efficacy and safety of alectinib, a second\u2010generation ALK inhibitor, in patients with relapsed or refractory ALK\u2010positive anaplastic large cell lymphoma (ALCL). This open\u2010label, phase II trial included patients (aged 6\u00a0years or older) with relapsed or refractory ALK\u2010positive ALCL. Alectinib 300\u00a0mg was given orally twice a day (600\u00a0mg\/d) for 16 cycles, and the duration of each cycle was 21\u00a0days. Patients who weighed less than 35\u00a0kg were given a reduced dose of alectinib of 150\u00a0mg twice a day (300\u00a0mg\/d). Ten patients were enrolled, and the median age was 19.5\u00a0years (range, 6\u201070\u00a0years). Objective responses were documented in eight of 10 patients (80%; 90% confidence interval, 56.2\u201095.9), with six complete responses. The 1\u2010year progression\u2010free survival, event\u2010free survival, and overall survival rates were 58.3%, 70.0%, and 70.0%, respectively. The median duration of therapy was 340\u00a0days. No unexpected adverse events occurred. The most common grade 3 and higher adverse event was a decrease in neutrophil count in two patients. Alectinib showed favorable clinical activity and was well tolerated in patients with ALK\u2010positive ALCL who had progressed on standard chemotherapy. Based on the results of the current study, the Ministry of Health, Labour and Welfare of Japan approved alectinib for the treatment of recurrent or refractory ALK\u2010positive ALCL in February 2020.<\/jats:p>","DOI":"10.1111\/cas.14671","type":"journal-article","created":{"date-parts":[[2020,10,3]],"date-time":"2020-10-03T10:06:29Z","timestamp":1601719589000},"page":"4540-4547","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":101,"title":["Alectinib for relapsed or refractory anaplastic lymphoma kinase\u2010positive anaplastic large cell lymphoma: An open\u2010label phase II trial"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4087-3426","authenticated-orcid":false,"given":"Reiji","family":"Fukano","sequence":"first","affiliation":[{"name":"Department of Pediatrics National Hospital Organization Kyushu Cancer Center Fukuoka 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