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A phase I study was carried out to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of E7777 in Japanese patients with relapsed\/refractory peripheral and cutaneous T\u2010cell lymphoma. E7777 (6, 12, and expanded 9\u00a0\u03bcg\/kg\/day) was given to 13 patients by i.v. infusion on five consecutive days per 21\u2010day cycle. Dose\u2010limiting toxicities, including increased alanine aminotransferase, hyponatremia (n\u00a0=\u00a02), hypokalemia, lymphopenia, fatigue, hypoalbuminemia, rash, and increased lipase (n\u00a0=\u00a01), were observed in all three patients in the 12\u00a0\u03bcg\/kg\/day cohort, whereas two of six patients in the 9\u00a0\u03bcg\/kg\/day cohort showed decreased appetite or fatigue. The maximum tolerated and recommended dose of E7777 was 9\u00a0\u03bcg\/kg\/day for five consecutive days per 21\u2010day cycle. The objective response rate was 38% (5\/13) and did not appear to depend on tumor expression of <jats:styled-content style=\"fixed-case\">CD<\/jats:styled-content>25. E7777 was well tolerated, assuming careful management of adverse events during treatment, and preliminary but clinically meaningful antitumor activity was observed. Subsequent studies of E7777 for T\u2010cell lymphomas are warranted. This study was registered with <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.ClinicalTrials.gov\">www.ClinicalTrials.gov<\/jats:ext-link> (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>1401530).<\/jats:p>","DOI":"10.1111\/cas.13513","type":"journal-article","created":{"date-parts":[[2018,1,24]],"date-time":"2018-01-24T06:58:59Z","timestamp":1516777139000},"page":"794-802","source":"Crossref","is-referenced-by-count":33,"title":["E7777 in Japanese patients with relapsed\/refractory peripheral and cutaneous T\u2010cell lymphoma: A phase I study"],"prefix":"10.1111","volume":"109","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5530-818X","authenticated-orcid":false,"given":"Ken","family":"Ohmachi","sequence":"first","affiliation":[{"name":"Department of Haematology and Oncology Tokai University School of Medicine Isehara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyoshi","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Haematology and Oncology Tokai University School of Medicine Isehara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michinori","family":"Ogura","sequence":"additional","affiliation":[{"name":"Department of Haematology and Oncology Japanese Red Cross Nagoya Daini Hospital Nagoya Japan"},{"name":"Department of Haematology Tokai Central Hospital Kakamigahara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Department of Haematology and Oncology Japanese Red Cross Nagoya Daini Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensei","family":"Tobinai","sequence":"additional","affiliation":[{"name":"Department of Haematology National Cancer Centre Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0654-6920","authenticated-orcid":false,"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Haematology National Cancer Centre Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Namiki","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Eisai Co., Ltd Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Clinical Development Eisai Co., Ltd Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,2,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11899-016-0353-y"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199304083281404"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2013.11.005"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.44.7524"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.27.7665"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.9024"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.37.4223"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.2782"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.38.0402"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.10.2434"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.28.9066"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.52.0924"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2016.146977"},{"key":"e_1_2_8_15_1","doi-asserted-by":"crossref","first-page":"12077","DOI":"10.1016\/S0021-9258(19)50310-6","article-title":"Structure\/function analysis of the transmembrane domain of DAB389\u2013interleukin\u20102, an interleukin\u20102 receptor\u2010targeted fusion toxin. 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