{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T02:26:31Z","timestamp":1793499991303,"version":"4.5.0"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T00:00:00Z","timestamp":1668988800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T00:00:00Z","timestamp":1668988800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Novartis Pharmaceutical Corporation"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Tisagenlecleucel yielded a high durable response rate in patients with relapsed\/refractory (r\/r) follicular lymphoma (FL) in the global phase 2 ELARA trial. Here, we report the efficacy, safety, and cellular kinetics of tisagenlecleucel in a subgroup of Japanese patients with r\/r FL from ELARA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>ELARA (NCT03568461) is a global single-arm trial of tisagenlecleucel in patients with r\/r FL who received\u2009\u2265\u20092 prior lines of therapy. The primary endpoint was the complete response rate (CRR), and the secondary endpoints were the overall response rate, duration of response, progression-free survival, overall survival, safety, and cellular kinetics.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>As of March 29, 2021, nine Japanese patients were enrolled and received tisagenlecleucel with a median follow-up of 13.6\u00a0months (range, 10.5\u201219.3). Per independent review committee, CRR was 100% (95% CI 63.1\u2012100). Within 8\u00a0weeks of infusion, cytokine release syndrome (CRS) of any grade was reported in 6 patients (66.7%); however, no grade\u2009\u2265\u20093 CRS or any grade serious neurological events or treatment-related deaths were observed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Tisagenlecleucel showed high efficacy and manageable safety in adult Japanese patients with r\/r FL. Moreover, the clinical outcomes were similar to the global population, which supports the potential of tisagenlecleucel in Japanese patients with r\/r FL.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12185-022-03481-y","type":"journal-article","created":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T03:02:36Z","timestamp":1668999756000},"page":"251-259","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial"],"prefix":"10.1007","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2682-2179","authenticated-orcid":false,"given":"Noriko","family":"Fukuhara","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Goto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tajima","family":"Takeshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mayu","family":"Kawaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kota","family":"Tokushige","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Akashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takanori","family":"Teshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideo","family":"Harigae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J.","family":"Schuster","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Thieblemont","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Dreyling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Fowler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,11,21]]},"reference":[{"key":"3481_CR1","doi-asserted-by":"publisher","first-page":"2375","DOI":"10.1182\/blood-2016-01-643569","volume":"127","author":"SH Swerdlow","year":"2016","unstructured":"Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, et al. 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Koji Kato is an advisor or consultant for AbbVie, AstraZeneca, Celgene, Chugai, Eisai, Janssen, and Novartis; has received honoraria from Celgene, Chugai, Janssen, Kyowa Kirin, Merck, Mundi, Novartis, Ono, Sumitomo Dainippon, Takeda; and reports research support from AbbVie, Celgene, Chugai, Eisai, Janssen, Kyowa Kirin, Ono, Novartis, Takeda. Hideki Gotohas received honoraria from Bristol-Myers Squibb, Eisai, Janssen, Chugai, Novartis, SymBio, Kyowa-Kirin, Astellas, MSD and Daiichi-Sankyo; and has received research grants from Bristol-Myers Squibb, SymBio and Kyowa-Kirin.. Tajima Takeshi, Mayu Kawaguchi, Kota Tokushige are employees of Novartis Pharma K.K. Koichi Akashi received research funding from AbbVie, Asahi Kasei, Astellas Pharma, Chugai, Daiichi Sankyo, Eisai, Kyowa Kirin, Mochida, MSD, Mundipharma, Nihon Shinyaku, Ono, Ostuka, Sanofi, Shin Nippon Biomedical laboratories, Shionogi, Sumitomo Dainippon, Taiho, Takeda, Toyama, Yakult; and consultant fees from AbbVie, Astellas Pharma, BMS, Celgene, Chugai, Eisai, Janssen, Kyowa Kirin, Novartis. Takanori Teshima is an advisor or consultant for Merck, Novartis, Takeda; has received honoraria from Bristol-Myers Squibb, Fuji Pharma, Kyowa Kirin, Merck, Nippon Shinyaku, Pfizer, Takeda, Teijin Pharma; reports research support from Astellas, Chugai Pharma, Kyowa Kirin, Novartis, Sanofi; reports grants from the Japan Society for the Promotion of Science and Japan Science and Technology Agency; and has received assistance with manuscript preparation for Janssen, Novartis. Hideo Harigae has received honoraria from BMS, Novartis, Chugai, Janssen; and reports research support from Astellas. Schuster J Stephen is an advisor or consultant for Acerta, AlloGene, AstraZeneca, BeiGene, Celgene\/Juno, Genentech\/Roche, Loxo Oncology, Novartis, Tessa Therapeutics; has received honoraria from Acerta, AlloGene, AstraZeneca, BeiGene, Celgene, Genentech\/Roche, Loxo Oncology, Novartis, Nordic Nanovector, Pfizer, Tessa Therapeutics; has participated in steering committees for AbbVie, Celgene, Novartis, Juno, Nordic Nanovector, Pfizer; reports research support from AbbVie, Acerta, Celgene\/Juno, DTRM Bio, Genentech, Incyte, Merck, Novartis, Portola, TG therapeutics; and holds a patent with Novartis. Catherine Thieblemont has received honoraria from Celgene, AbbVie, Bayer, Janssen, Roche, Incyte, Novartis, Gilead; reports research funding from Roche; and travel support from Roche, Janssen-Cilag, Kite\/Gilead, Novartis. Martin Dreyling is a scientific advisory board member for Astra Zeneca, Beigene, BMS\/Celgene, Genmab, Gilead\/Kite, Incyte, Janssen, Lilly\/Loxo, Morphosys, Novartis, Roche; received honoraria from Amgen, Astra Zeneca, BMS\/Celgene, Gilead\/Kite, Incyte, Janssen, Novartis, Roche; reports research support from Abbvie, Bayer, BMS\/Celgene, Gilead\/Kite, Janssen, Roche. Nathan Fowler is an advisor or consultant for Roche\/Genentech, TG Therapeutics, Verastem, Bayer, Celgene, Novartis; and reports research support from Roche, Celgene, Gilead Sciences, TG Therapeutics, Novartis, AbbVie, BeiGene.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}