{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T15:29:14Z","timestamp":1771342154507,"version":"3.50.1"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"AbbVie G.K."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This phase 2 study (NCT05105841) evaluated the safety and efficacy of a fixed-duration 12-cycle regimen of venetoclax plus obinutuzumab in Japanese patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary efficacy endpoint was the complete remission (CR)\/complete remission with incomplete marrow recovery (CRi) rate, assessed by an independent review committee (IRC) according to the 2008 International Workshop on CLL criteria. Ten patients (6 male, 4 female; 9 CLL, 1 SLL) with a median age of 69.5\u00a0years (range 52\u201376) received venetoclax for a median duration of 11.3\u00a0months (range 9.2\u201312.4). The IRC-assessed CR\/CRi rate based on the best overall response was 90.0% (95% confidence interval 55.5%, 99.7%). All patients experienced at least one treatment-emergent adverse event (TEAE), and three patients (30.0%) experienced at least one serious TEAE. The most common TEAEs included infusion-related reactions (60.0%), decreased neutrophil count (50.0%), and nausea (40.0%). Nine patients (90.0%) experienced TEAEs related to venetoclax, while all ten patients (100.0%) had TEAEs related to obinutuzumab. One patient (10.0%) developed COVID-19 pneumonia, necessitating the discontinuation of venetoclax. These findings demonstrate the high efficacy and manageable safety profile of venetoclax plus obinutuzumab in this patient population.<\/jats:p>","DOI":"10.1007\/s12185-025-04095-w","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T08:37:59Z","timestamp":1762763879000},"page":"225-232","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of fixed-duration venetoclax plus obinutuzumab in untreated Japanese CLL and SLL: a phase 2 study"],"prefix":"10.1007","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-8057","authenticated-orcid":false,"given":"Koji","family":"Izutsu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsumasa","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomomi","family":"Toubai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taku","family":"Tsukamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Kumode","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriko","family":"Fukuhara","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":"Jun","family":"Takizawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,11,10]]},"reference":[{"key":"4095_CR1","doi-asserted-by":"publisher","first-page":"16096","DOI":"10.1038\/nrdp.2016.96","volume":"3","author":"TJ Kipps","year":"2017","unstructured":"Kipps TJ, Stevenson FK, Wu CJ, Croce CM, Packham G, Wierda WG, et al. 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Jun Takizawa has received consulting fees (including expert testimony) from Janssen, AstraZeneca, and AbbVie; has received research funding from AstraZeneca, Mitsubishi Tanabe, AbbVie, BeiGene, Novartis, Chugai, Kyowa Kirin, Nippon Kayaku, Janssen, Eli Lilly, and Asahi Kasei; and has received honoraria from Janssen, AstraZeneca, AbbVie, Novartis, BeiGene, Chugai, Kyowa Kirin, and Nippon Kayaku. Tomomi Toubai has received honoraria from Takeda and research grants from IQVIA, AbbVie, Meiji Seika Pharma, Novartis, Chugai, Pfizer, Sanofi, Amgen, Incyte, and Zenyaku. Dai Maruyama has served as consultant or adviser for Janssen, AstraZeneca, Chugai, AbbVie, Genmab, Sanofi, BMS, and Pfizer; has received honoraria from Ono, Nippon Shinyaku, Janssen, Mundipharma, Eisai, Chugai, Kyowa Kirin, MSD, Zenyaku, Sanofi, Symbio, Takeda, AbbVie, AstraZeneca, BMS, Genmab, Novartis, Pfizer, and Roche; and has received research grants from Ono, Janssen, Eisai, Chugai, Roche, Kyowa Kirin, MSD, Zenyaku, Sanofi, Symbio, Takeda, AbbVie, AstraZeneca, BMS, Genmab, Novartis, Otsuka, Taiho, Pfizer, and Astellas. Takahiro Kumode has received honoraria from Janssen, AstraZeneca, AbbVie, Genmab, BeiGene, and Ono Pharmaceutical. Noriko Fukuhara has received research grants from AbbVie, Kaiwa Pharma, Chugai Pharma, and Ono Pharma and is an editor of the\n                      International Journal of Hematology.\n                      Natsumi Ogawa, Natsuko Satomi, Yasuko Nishimura, Hideyuki Honda, and Brenda Chyla are employees and stockholders of AbbVie. Koji Izutsu has received research grants from AstraZeneca, AbbVie, Incyte, Bristol Myers Squibb, Novartis, Yakult, Daiichi Sankyo, Chugai, BeiGene, Genmab, LOXO Oncology, Otsuka, and Regeneron.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12\u00a0months, with possible extensions considered. For more information on the process or to submit a request, visit the following link:\n                      \n                      then select \u201cHome\u201d.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}}]}}