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We conducted a phase 2, open-label, multicenter, non-comparative study to evaluate the safety and efficacy of fixed-duration venetoclax plus ibrutinib in 10 patients with previously untreated CLL\/SLL (7 CLL\/3 SLL). The primary endpoint was the rate of complete remission (CR)\/CR with incomplete marrow recovery (CRi) assessed by the independent review committee (IRC). The median age was 72.5 (range 61\u201377) years. The IRC-assessed CR\/CRi rate was 60.0% (95% confidence interval: 26.2\u201387.8%), exceeding the pre-specified efficacy threshold of 10% and meeting the primary endpoint. The median venetoclax treatment duration was 11.0 (range 2.1\u201317.7) months. At a median follow-up of 20.6\u00a0months, the secondary endpoints of median progression-free and overall survival were not estimated. The overall undetectable measurable residual disease rate was 60.0%. All patients experienced treatment-emergent adverse events (TEAEs), including 7 (70.0%) with grade 3\/4 and 2 (20.0%) with serious TEAEs, respectively, and 1 discontinued venetoclax because of a TEAE (increased blood creatine phosphokinase). These findings suggest that venetoclax plus ibrutinib has a favorable benefit\u2013risk profile with high efficacy and manageable safety.<\/jats:p>","DOI":"10.1007\/s12185-025-04114-w","type":"journal-article","created":{"date-parts":[[2025,11,28]],"date-time":"2025-11-28T09:20:44Z","timestamp":1764321644000},"page":"375-384","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A phase 2 study of ibrutinib with venetoclax in Japanese patients with untreated CLL and SLL"],"prefix":"10.1007","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-7125-3927","authenticated-orcid":false,"given":"Jun","family":"Takizawa","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isao","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiaki","family":"Ogawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomomi","family":"Toubai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeru","family":"Kusumoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsumasa","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natsumi","family":"Ogawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natsuko","family":"Satomi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuko","family":"Nishimura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideyuki","family":"Honda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brenda","family":"Chyla","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,11,28]]},"reference":[{"key":"4114_CR1","doi-asserted-by":"publisher","first-page":"432","DOI":"10.1007\/s12185-025-03914-4","volume":"121","author":"Y Takamatsu","year":"2025","unstructured":"Takamatsu Y. 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Isao Yoshida: Honoraria: Chugai, Kyowa Kirin, AstraZeneca, Eisai, Janssen, Daiichi Sankyo, AbbVie, Nippon Shinyaku. Yoshiaki Ogawa: None. Tomomi Toubai: Honoraria: Takeda; Research grants: IQVIA, AbbVie, Meiji Seika Pharma, Novartis, Chugai, Pfizer, Sanofi, Amgen, Incyte, Zenyaku. Shigeru Kusumoto: Consultant\/adviser: Lilly, Chugai Pharmaceutical, Kyowa Kirin, Genmab, and Janssen; Honoraria: Chugai Pharmaceutical, Eisai, Janssen, Meiji Seika Pharma, AbbVie, Nippon Shinyaku, Astellas Pharma, Novartis, Zenyaku, Fujimoto Pharmaceutical, Daiichi Sankyo, SymBio Pharmaceuticals, Ono Pharmaceutical, Lilly, Genmab, Sanofi, Takeda Pharmaceuticals, Sumitomo Pharma, Mundipharma, AstraZeneca; Research grants: Bristol Myers Squibb, Chugai Pharmaceutical, Ono Pharmaceutical, Genmab, Meiji Seika Pharma, Janssen, Takeda Pharmaceuticals, AbbVie. Mitsumasa Watanabe: None. Natsumi Ogawa: Stock holdings: AbbVie; Employment: AbbVie. Natsuko Satomi: Stock holdings: AbbVie; Employment: AbbVie. Yasuko Nishimura: Stock holdings: AbbVie; Employment: AbbVie. Hideyuki Honda: Stock holdings: AbbVie; Employment: AbbVie. Brenda Chyla: Stock holdings: AbbVie; Employment: AbbVie. Koji Izutsu: Writing payment: None; Research grants: AstraZeneca, AbbVie, Incyte, Bristol Myers Squibb, Novartis, Yakult, Daiichi Sankyo, Chugai, BeiGene, Genmab, LOXO Oncology, Otsuka, Regeneron.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}