{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T03:37:34Z","timestamp":1792553854647,"version":"4.5.0"},"reference-count":12,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2020,5,24]],"date-time":"2020-05-24T00:00:00Z","timestamp":1590278400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,5,24]],"date-time":"2020-05-24T00:00:00Z","timestamp":1590278400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100008272","name":"Novartis Pharmaceuticals Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008272","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008792","name":"Novartis Pharma K.K.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Tisagenlecleucel demonstrated a high rate of durable response in adult patients with relapsed\/refractory (r\/r) diffuse large B-cell lymphoma (DLBCL) in the pivotal global phase\u00a02 JULIET study. Here, we report the efficacy and safety of tisagenlecleucel in the Japanese subgroup.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>JULIET (NCT02445248) is a single-arm, open-label, multicenter, phase 2 study involving adult patients with r\/r DLBCL who either relapsed after or were ineligible for autologous stem cell transplant. Primary endpoint was best overall response rate (ORR; complete response [CR]\u2009+\u2009partial response [PR]) as judged by an independent review committee.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In Japan, of 17 patients enrolled, 9 were infused with tisagenlecleucel and completed\u2009\u2265\u20093\u00a0months of follow-up. Best ORR was 77.8% (7\/9; 95% confidence interval, 40.0\u201397.2), with 5 patients (55.6%) in CR and 2 (22.2%) in PR. Cytokine release syndrome (CRS) occurred in 6 patients (66.7%), with grade 3 CRS in 2\u00a0patients (Penn grading scale). Two patients received tocilizumab. Two deaths (22.2%) occurred more than 30\u00a0days after tisagenlecleucel infusion due to disease progression, neither of which were related to tisagenlecleucel.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Tisagenlecleucel showed a high best ORR with a manageable safety profile, thus offering a new treatment option in selected Japanese patients with r\/r DLBCL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-020-01699-6","type":"journal-article","created":{"date-parts":[[2020,5,24]],"date-time":"2020-05-24T04:02:26Z","timestamp":1590292946000},"page":"1736-1743","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Efficacy and safety of tisagenlecleucel in Japanese adult patients with relapsed\/refractory diffuse large B-cell lymphoma"],"prefix":"10.1007","volume":"25","author":[{"given":"Hideki","family":"Goto","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Makita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kota","family":"Tokushige","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taizo","family":"Fujita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Akashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takanori","family":"Teshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,5,24]]},"reference":[{"key":"1699_CR1","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1111\/j.1440-1827.2007.02207.x","volume":"58","author":"R Aoki","year":"2008","unstructured":"Aoki R, Karube K, Sugita Y et al (2008) Distribution of malignant lymphoma in Japan: analysis of 2260 cases, 2001\u20132006. Pathol Int 58:174\u2013182","journal-title":"Pathol Int"},{"key":"1699_CR2","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1182\/blood-2014-05-577189","volume":"125","author":"LH Sehn","year":"2015","unstructured":"Sehn LH, Gascoyne RD (2015) Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood 125:22\u201332","journal-title":"Blood"},{"key":"1699_CR3","doi-asserted-by":"publisher","first-page":"1800","DOI":"10.1182\/blood-2017-03-769620","volume":"130","author":"M Crump","year":"2017","unstructured":"Crump M, Neelapu SS, Farooq U et al (2017) Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood 130:1800\u20131808","journal-title":"Blood"},{"key":"1699_CR4","doi-asserted-by":"publisher","first-page":"1109","DOI":"10.1111\/cas.13239","volume":"108","author":"S Makita","year":"2017","unstructured":"Makita S, Yoshimura K, Tobinai K (2017) Clinical development of anti-CD19 chimeric antigen receptor T-cell therapy for B-cell non-Hodgkin lymphoma. Cancer Sci 108:1109\u20131118","journal-title":"Cancer Sci"},{"key":"1699_CR5","doi-asserted-by":"publisher","first-page":"2545","DOI":"10.1056\/NEJMoa1708566","volume":"377","author":"SJ Schuster","year":"2017","unstructured":"Schuster SJ, Svoboda J, Chong EA et al (2017) Chimeric antigen receptor T cells in refractory B-cell lymphomas. N Engl J Med 377:2545\u20132554","journal-title":"N Engl J Med"},{"key":"1699_CR6","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1056\/NEJMoa1804980","volume":"380","author":"SJ Schuster","year":"2019","unstructured":"Schuster SJ, Bishop MR, Tam CS et al (2019) Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 380:45\u201356","journal-title":"N Engl J Med"},{"key":"1699_CR7","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1200\/JCO.2006.09.2403","volume":"25","author":"BD Cheson","year":"2007","unstructured":"Cheson BD, Pfistner B, Juweid ME et al (2007) Revised response criteria for malignant lymphoma. J Clin Oncol 25:579\u2013586","journal-title":"J Clin Oncol"},{"key":"1699_CR8","unstructured":"U.S. Department for Health and Human Services (2010) Common Terminology Criteria for Adverse Events v4.03. https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed Jan 2019"},{"key":"1699_CR9","doi-asserted-by":"publisher","first-page":"303ra139","DOI":"10.1126\/scitranslmed.aac5415","volume":"7","author":"DL Porter","year":"2015","unstructured":"Porter DL, Hwang WT, Frey NV et al (2015) Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med 7:303ra139","journal-title":"Sci Transl Med"},{"key":"1699_CR10","doi-asserted-by":"publisher","first-page":"7505","DOI":"10.1200\/JCO.2018.36.15_suppl.7505","volume":"36","author":"JS Abramson","year":"2018","unstructured":"Abramson JS, Gordon LI, Palomba ML et al (2018) Updated safety and long term clinical outcomes in TRANSCEND NHL 001, pivotal trial of lisocabtagene maraleucel (JCAR017) in R\/R aggressive NHL. J Clin Oncol 36:7505","journal-title":"J Clin Oncol"},{"key":"1699_CR11","doi-asserted-by":"publisher","first-page":"2531","DOI":"10.1056\/NEJMoa1707447","volume":"377","author":"SS Neelapu","year":"2017","unstructured":"Neelapu SS, Locke FL, Bartlett NL et al (2017) Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 377:2531\u20132544","journal-title":"N Engl J Med"},{"issue":"supplement_1","key":"1699_CR12","doi-asserted-by":"publisher","first-page":"4103","DOI":"10.1182\/blood-2019-129107","volume":"134","author":"JR Westin","year":"2019","unstructured":"Westin JR, Tam CS, Borchmann P et al (2019) Correlative analyses of patient and clinical characteristics associated with efficacy in tisagenlecleucel-treated relapsed\/refractory diffuse large b-cell lymphoma patients in the Juliet trial. Blood 134(supplement_1):4103","journal-title":"Blood"}],"container-title":["International Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-020-01699-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10147-020-01699-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-020-01699-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,23]],"date-time":"2021-05-23T19:26:49Z","timestamp":1621798009000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10147-020-01699-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,24]]},"references-count":12,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2020,9]]}},"alternative-id":["1699"],"URL":"https:\/\/doi.org\/10.1007\/s10147-020-01699-6","relation":{},"ISSN":["1341-9625","1437-7772"],"issn-type":[{"value":"1341-9625","type":"print"},{"value":"1437-7772","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,24]]},"assertion":[{"value":"3 February 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 May 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 May 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"S.M. received personal fees from Novartis, Takeda, Eisai, Daiichi Sankyo, and Celgene. K.A. reports research grants from Novartis, MSD, Asahi Kasei Pharma, Astellas, AbbVie, Alexion, Chemo-Sero-Therapeutic Research Institute, Japan Blood Products Organization, Eisai, Otsuka, Ono, Yakult, Shin Nippon Biomedical Laboratories, Kyowa Hakko Kirin, Sanofi, Shionogi, Daiichi Sankyo, Taisho, Dainippon Sumitomo, Taiho, Takeda, Mitsubishi Tanabe, Chugai, Teijin, FUJIFILM Toyoma Chemical, Eli Lilly, Nippon Kayaku, Bayer, Bristol-Myers Squibb, Mundipharma, Merck, Mochida, and Nihon Pharmaceutical, and personal fees from Novartis, CSL Behring, MSD, Asahi Kasei Pharma, Astellas Amgen, Astellas, AbbVie, Alexion, Eisai, Otsuka, Ono, Medical Review, Kyowa Hakko Kirin, Sanofi, Shionogi, Shire Japan, SymBio, Celgene, Daiichi Sankyo, Taisho, Dainippon Sumitomo, Takeda, Mitsubishi Tanabe, Chugai, Teijin, Nippon Shinyaku, Eli Lilly, Bayer, Pfizer, Bristol-Myers Squibb, Mundi Pharma, Mochida, and Janssen. K.I. reports research grants from Novartis, Eisai, Kyowa Hakko Kirin, MSD, Takeda, Janssen, Mundipharma, Chugai, AbbVie, Bayer, Ono, Gilead, Zenyaku, Celgene, Solasia, Symbio, Astellas, Astellas Amgen, and Daiichi Sankyo, and personal fees from Kyowa Hakko Kirin, MSD, Takeda, Janssen, Bristol-Myers Squibb, Dainippon Sumitomo, Mundipharma, Nihon Mediphysics, Chugai, Astra Zeneca, AbbVie, Bayer, Ono, and Celgene. T.T. reports research grants and personal fees from Novartis. K.T. and T.F. are employees of Novartis. All other authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}