{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T20:41:44Z","timestamp":1786394504075,"version":"build-2736575974"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2024,8,21]],"date-time":"2024-08-21T00:00:00Z","timestamp":1724198400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,21]],"date-time":"2024-08-21T00:00:00Z","timestamp":1724198400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"AbbVie GK"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>Venetoclax was approved for relapsed\/refractory chronic lymphocytic leukemia (R\/R CLL) and small lymphocytic leukemia (SLL) in Japan in September 2019; however, clinical data in Japanese patients are limited. This all-case post-marketing surveillance assessed efficacy and safety in Japanese patients with R\/R CLL\/SLL who started venetoclax treatment between November 2019 and August 2020. Overall, the safety and efficacy analysis sets included 129 and 114 patients, respectively. The overall response rate (ORR) was 57.0%; ORRs were higher in patients with versus without concomitant rituximab (65.4% vs. 54.7%), and in patients with 1 versus\u2009\u2265\u20092 prior lines of therapies (72.5% vs. 44.4%). Adverse events (AEs) were reported in 66.7% of patients (86\/129); the most common AEs were neutrophil count decreased (22.5%), white blood cell count decreased (7.8%), and tumor lysis syndrome (TLS; 6.2%). AEs of special interest (TLS, myelosuppression, and infection) were manageable in clinical practice in Japan. Venetoclax is efficacious and safe for R\/R CLL\/SLL patients in the real-world setting in Japan. <jats:italic>ClinicalTrials.gov ID:<\/jats:italic> NCT04198415.<\/jats:p>","DOI":"10.1007\/s12185-024-03832-x","type":"journal-article","created":{"date-parts":[[2024,8,22]],"date-time":"2024-08-22T16:45:45Z","timestamp":1724345145000},"page":"613-620","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Venetoclax treatment for chronic lymphocytic leukemia\/small lymphocytic leukemia in Japan: post-marketing surveillance"],"prefix":"10.1007","volume":"120","clinical-trial-number":[{"clinical-trial-number":"nct04198415","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5419-9156","authenticated-orcid":false,"given":"Tomoki","family":"Ito","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiko","family":"Kamimura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Kiguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Risa","family":"Takenaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariko","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayumi","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mizu","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,21]]},"reference":[{"key":"3832_CR1","doi-asserted-by":"publisher","first-page":"2205","DOI":"10.3324\/haematol.2019.236000","volume":"105","author":"J Delgado","year":"2020","unstructured":"Delgado J, Nadeu F, Colomer D, Campo E. Chronic lymphocytic leukemia: from molecular pathogenesis to novel therapeutic strategies. Haematologica. 2020;105:2205\u201317.","journal-title":"Haematologica"},{"key":"3832_CR2","doi-asserted-by":"publisher","first-page":"941","DOI":"10.1038\/s41419-020-03144-y","volume":"11","author":"I Kapoor","year":"2020","unstructured":"Kapoor I, Bodo J, Hill BT, Hsi ED, Almasan A. Targeting BCL-2 in B-cell malignancies and overcoming therapeutic resistance. Cell Death Dis. 2020;11:941.","journal-title":"Cell Death Dis"},{"key":"3832_CR3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1182\/hematology.2020000154","volume":"2020","author":"AW Roberts","year":"2020","unstructured":"Roberts AW. Therapeutic development and current uses of BCL-2 inhibition. Hematol Am Soc Hematol Educ Program. 2020;2020:1\u20139.","journal-title":"Hematol Am Soc Hematol Educ Program"},{"key":"3832_CR4","unstructured":"Pharmaceutical and Medical Devices Agency. List of approved products (FY 2019). 2019. https:\/\/www.pmda.go.jp\/files\/000235289.pdf. Accessed 7 Mar 2023."},{"key":"3832_CR5","unstructured":"Pharmaceutical and Medical Devices Agency. VENCLEXTA tablets: Japanese prescribing information. 2023. https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/ResultDataSetPDF\/112130_4291062F3023_1_06. Accessed 5 Oct 2023."},{"key":"3832_CR6","doi-asserted-by":"publisher","first-page":"1107","DOI":"10.1056\/NEJMoa1713976","volume":"378","author":"JF Seymour","year":"2018","unstructured":"Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D\u2019Rozario J, Assouline S, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378:1107\u201320.","journal-title":"N Engl J Med"},{"key":"3832_CR7","doi-asserted-by":"publisher","first-page":"370","DOI":"10.1007\/s12185-020-03024-3","volume":"113","author":"K Izutsu","year":"2021","unstructured":"Izutsu K, Yamamoto K, Kato K, Ishikawa T, Fukuhara N, Terui Y, et al. Phase 1\/2 study of venetoclax, a BCL-2 inhibitor, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Int J Hematol. 2021;113:370\u201380.","journal-title":"Int J Hematol"},{"key":"3832_CR8","doi-asserted-by":"publisher","first-page":"2745","DOI":"10.1182\/blood-2017-09-806398","volume":"131","author":"M Hallek","year":"2018","unstructured":"Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, D\u00f6hner H, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131:2745\u201360.","journal-title":"Blood"},{"key":"3832_CR9","doi-asserted-by":"publisher","first-page":"621","DOI":"10.1002\/hon.3122","volume":"41","author":"L Laurenti","year":"2023","unstructured":"Laurenti L, Scarf\u00f2 L, Frustaci AM, Sanna A, Iannella E, Caira M, et al. Real-world evidence on venetoclax in chronic lymphocytic leukemia: the Italian experience. Hematol Oncol. 2023;41:621\u201330.","journal-title":"Hematol Oncol"},{"key":"3832_CR10","doi-asserted-by":"publisher","first-page":"2119","DOI":"10.1007\/s00277-023-05304-4","volume":"102","author":"A Sobo\u0144","year":"2023","unstructured":"Sobo\u0144 A, Drozd-Soko\u0142owska J, Paszkiewicz-Kozik E, Pop\u0142awska L, Morawska M, Tryc-Szponder J, et al. Clinical efficacy and tolerability of venetoclax plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia-a real-world analysis of the Polish Adult Leukemia Study Group. Ann Hematol. 2023;102:2119\u201326.","journal-title":"Ann Hematol"},{"key":"3832_CR11","doi-asserted-by":"publisher","first-page":"1844","DOI":"10.1056\/NEJMra0904569","volume":"364","author":"SC Howard","year":"2011","unstructured":"Howard SC, Jones DP, Pui CH. The tumor lysis syndrome. N Engl J Med. 2011;364:1844\u201354.","journal-title":"N Engl J Med"},{"key":"3832_CR12","doi-asserted-by":"publisher","first-page":"2383","DOI":"10.1080\/10428194.2020.1768384","volume":"61","author":"AB Koehler","year":"2020","unstructured":"Koehler AB, Leung N, Call TG, Rabe KG, Achenbach SJ, Ding W, et al. Incidence and risk of tumor lysis syndrome in patients with relapsed chronic lymphocytic leukemia (CLL) treated with venetoclax in routine clinical practice. Leuk Lymphoma. 2020;61:2383\u20138.","journal-title":"Leuk Lymphoma"},{"key":"3832_CR13","doi-asserted-by":"publisher","first-page":"1511","DOI":"10.3324\/haematol.2018.193615","volume":"103","author":"AR Mato","year":"2018","unstructured":"Mato AR, Thompson M, Allan JN, Brander DM, Pagel JM, Ujjani CS, et al. Real-world outcomes and management strategies for venetoclax-treated chronic lymphocytic leukemia patients in the United States. Haematologica. 2018;103:1511\u20137.","journal-title":"Haematologica"},{"issue":"15_Suppl","key":"3832_CR14","doi-asserted-by":"publisher","first-page":"7529","DOI":"10.1200\/JCO.2018.36.15_suppl.7529","volume":"36","author":"C Nabhan","year":"2018","unstructured":"Nabhan C, Klink A, Samp J, Pauff JM, Nielsen J, Meissner B, et al. Management and outcomes of 222 CLL patients (pts) treated with venetoclax (VEN) in the real world [ASCO abstract]. J Clin Oncol. 2018;36(15_Suppl):7529.","journal-title":"J Clin Oncol"},{"key":"3832_CR15","doi-asserted-by":"publisher","first-page":"4264","DOI":"10.1158\/1078-0432.CCR-19-0361","volume":"25","author":"LE Roeker","year":"2019","unstructured":"Roeker LE, Fox CP, Eyre TA, Brander DM, Allan JN, Schuster SJ, et al. Tumor lysis, adverse events, and dose adjustments in 297 venetoclax-treated CLL patients in routine clinical practice. Clin Cancer Res. 2019;25:4264\u201370.","journal-title":"Clin Cancer Res"},{"key":"3832_CR16","doi-asserted-by":"publisher","DOI":"10.1097\/01.HS9.0000974572.50349.42","volume":"7","author":"I Schwaner","year":"2023","unstructured":"Schwaner I, Hebart H, Christoph L, Thomas W, Burkard S, Rossi D, et al. PB1938: real world effectiveness and safety of venetoclax in combination with obinutuzumab in treatment naive CLL patients \u2013 data from the observational study VERVE [EHA abstract]. HemaSphere. 2023;7: e5034942.","journal-title":"HemaSphere"},{"key":"3832_CR17","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1182\/hematology.2020000120","volume":"2020","author":"K Fischer","year":"2020","unstructured":"Fischer K, Al-Sawaf O, Hallek M. Preventing and monitoring for tumor lysis syndrome and other toxicities of venetoclax during treatment of chronic lymphocytic leukemia. Hematol Am Soc Hematol Educ Progr. 2020;2020:357\u201362.","journal-title":"Hematol Am Soc Hematol Educ Progr"},{"key":"3832_CR18","first-page":"59","volume":"12","author":"A Goodrich","year":"2021","unstructured":"Goodrich A. Advanced practice perspectives on preventing and managing tumor lysis syndrome and neutropenia in chronic lymphocytic leukemia. J Adv Pract Oncol. 2021;12:59\u201370.","journal-title":"J Adv Pract Oncol"},{"key":"3832_CR19","doi-asserted-by":"publisher","first-page":"1497","DOI":"10.1080\/17512433.2021.2008239","volume":"14","author":"M Siddiqui","year":"2021","unstructured":"Siddiqui M, Konopleva M. Keeping up with venetoclax for leukemic malignancies: key findings, optimal regimens, and clinical considerations. Expert Rev Clin Pharmacol. 2021;14:1497\u2013512.","journal-title":"Expert Rev Clin Pharmacol"},{"key":"3832_CR20","doi-asserted-by":"publisher","first-page":"387","DOI":"10.1016\/j.htct.2023.05.006","volume":"45","author":"M Guarana","year":"2023","unstructured":"Guarana M, Nucci M. Infections in patients with chronic lymphocytic leukemia. Hematol Transfus Cell Ther. 2023;45:387\u201393.","journal-title":"Hematol Transfus Cell Ther"}],"updated-by":[{"DOI":"10.1007\/s12185-025-03978-2","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T00:00:00Z","timestamp":1744329600000}}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-024-03832-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-024-03832-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-024-03832-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T10:27:19Z","timestamp":1744367239000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-024-03832-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,21]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["3832"],"URL":"https:\/\/doi.org\/10.1007\/s12185-024-03832-x","relation":{"correction":[{"id-type":"doi","id":"10.1007\/s12185-025-03978-2","asserted-by":"object"}]},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,21]]},"assertion":[{"value":"26 January 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 July 2024","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 August 2024","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 August 2024","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 April 2025","order":5,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":6,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s12185-025-03978-2","URL":"https:\/\/doi.org\/10.1007\/s12185-025-03978-2","order":8,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"TI has received lecture fees from Bristol-Myers Squibb K.K., Mundipharma K.K., Novartis Pharma K.K., Takeda Pharmaceutical Co. Ltd., AbbVie G.K., Chugai Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Nippon Shinyaku Co. Ltd., SymBio Pharmaceuticals Co. Ltd., CSL Behring K.K., and Sanofi K.K.; and grants and research funds from Bristol-Myers Squibb K.K. and AbbVie G.K. T Kamimura has received lecture fees from Janssen Pharmaceutical K.K., Ono Pharmaceutical Co. Ltd., and AbbVie G.K. T Kiguchi has received lecture fees from Bristol-Myers Squibb K.K., Novartis Pharma K.K., and SymBio Pharmaceuticals Co. Ltd.; grants from Daiichi Sankyo Co. Ltd., SymBio Pharmaceuticals Co. Ltd., Janssen Pharma K.K., and Otsuka Pharmaceutical Co. Ltd.; and consultancy fees from Astellas Pharma Inc. KK has received consultancy fees from AbbVie G.K., AstraZeneca K.K., Celgene K.K., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Janssen Pharma K.K., Daiichi Sankyo Co. Ltd., Ono Pharmaceutical Co. Ltd., and Novartis Pharma K.K.; and lecture and manuscript fees from Bristol-Myers Squibb K.K., Celgene K.K., Sumitomo Dainippon Pharma Co. Ltd., Janssen Pharma K.K., Kyowa Kirin Co. Ltd., MSD K.K., Mundipharma K.K., Ono Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., AbbVie G.K., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., and Chugai Pharmaceutical Co. Ltd. KI has received research funding from AbbVie G.K., AstraZeneca K.K., BeiGene, Celgene K.K., Chugai Pharmaceutical Co. Ltd., Janssen Pharma K.K., Novartis Pharma K.K., and Yakult Honsha Co. Ltd.; and lecture fees from Janssen Pharma K.K., AbbVie G.K., Novartis Pharma K.K., Celgene K.K., AstraZeneca K.K., and Chugai Pharmaceutical Co. Ltd. RT, MK, AI, and MS are employees of AbbVie G.K.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}