{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T19:30:45Z","timestamp":1768073445223,"version":"3.49.0"},"reference-count":27,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,6,14]],"date-time":"2024-06-14T00:00:00Z","timestamp":1718323200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","award":["X2504"],"award-info":[{"award-number":["X2504"]}],"id":[{"id":"10.13039\/100008373","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Brentuximab vedotin (BV), a conjugate of anti\u2010CD30 antibody and monomethyl auristatin E, has emerged as a promising treatment option for refractory CD30+ mycosis fungoides (MF) and primary cutaneous anaplastic large\u2010cell lymphoma (pcALCL). BV has been shown to be safe and effective in treating Hodgkin's lymphoma and peripheral T\u2010cell lymphoma. This multicenter, prospective, single\u2010arm phase I\/II study evaluated the efficacy of BV in Japanese patients with CD30+ cutaneous lymphomas, namely CD30+ cutaneous T\u2010cell lymphoma. Participants were divided into two groups: those with CD30+ MF or pcALCL (cohort 1, <jats:italic>n<\/jats:italic>\u2009=\u200913) and those with CD30+ lymphoproliferative disorders other than those in cohort 1 (cohort 2, <jats:italic>n<\/jats:italic>\u2009=\u20093). The studied population included the full analysis set (FAS), modified FAS (mFAS), and safety analysis set (SAF). These sets were identified in cohorts 1 and 1\u2009+\u20092 and labeled FAS1 and FAS2, mFAS1 and mFAS2, and SAF1 and SAF2, respectively. Each treatment cycle lasted 3\u2009weeks, and BV was continued for up to 16 cycles after the third cycle based on treatment response. The primary endpoint was the 4\u2010month objective response rate (ORR4) determined by the Independent Review Forum (IRF). ORR4 was 69.2% for FAS1 and 62.5% for FAS2 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). Secondary endpoints of ORR, assessed using the global response score (53.8% in FAS1) and modified severity\u2010weighted assessment tool (62.5% in FAS1), using the IRF, provided results comparable to the primary findings. The incidence of \u2265grade 3 adverse events (\u226515%) in SAF1 was peripheral neuropathy in three patients (23%) and fever and eosinophilia in two patients (15%). In conclusion, BV showed favorable efficacy, tolerability, and safety profile in Japanese patients with relapsed or refractory CD30+ primary cutaneous T\u2010cell lymphoma. The trial was registered with University Hospital Medical Information Network Clinical Trials Registry, Japan (protocol ID: UMIN000034205).<\/jats:p>","DOI":"10.1111\/1346-8138.17324","type":"journal-article","created":{"date-parts":[[2024,6,14]],"date-time":"2024-06-14T13:09:18Z","timestamp":1718370558000},"page":"1037-1049","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Phase <scp>I\/II<\/scp> clinical trial of brentuximab vedotin for pretreated Japanese patients with <scp>CD30<\/scp>\u2010positive cutaneous T\u2010cell lymphoma"],"prefix":"10.1111","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2201-6129","authenticated-orcid":false,"given":"Yoji","family":"Hirai","sequence":"first","affiliation":[{"name":"Department of Dermatology Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University  Okayama 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