{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T13:30:58Z","timestamp":1782307858412,"version":"3.54.5"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T00:00:00Z","timestamp":1680652800000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>In a Phase 3 international clinical trial (VIALE-C), venetoclax plus low-dose cytarabine improved the response rate and overall survival versus placebo plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia who were ineligible for intensive chemotherapy. After the enrollment period of VIALE-C ended, we conducted an expanded access study to provide preapproval access to venetoclax in combination with low-dose cytarabine in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Previously, untreated patients with acute myeloid leukemia who were ineligible for intensive chemotherapy were enrolled according to the VIALE-C criteria. Patients received venetoclax (600\u00a0mg, Days 1\u201328, 4-day ramp-up in Cycle 1) in 28-day\u00a0cycles and low-dose cytarabine (20\u00a0mg\/m2, Days 1\u201310). All patients took tumor lysis syndrome prophylactic agents and hydration. Safety endpoints were assessed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Fourteen patients were enrolled in this study. The median age was 77.5\u00a0years (range = 61\u201384), with 78.6% over 75\u00a0years old. The most common grade\u00a0\u2265\u00a03 treatment-emergent adverse event was neutropenia (57.1%). Febrile neutropenia was the most frequent serious adverse event (21.4%). One patient developed treatment-related acute kidney injury, leading to discontinuation of treatment. Two patients died because of cardiac failure and disease progression that were judged not related to study treatment. No patients developed tumor lysis syndrome.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The safety outcomes were similar to those in VIALE-C without new safety signals and were well managed with standard medical care. In clinical practice, more patients with severe background disease are expected, in comparison with in VIALE-C, suggesting that it is important to carefully manage and prevent adverse events.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyad027","type":"journal-article","created":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T12:01:52Z","timestamp":1680696112000},"page":"595-603","source":"Crossref","is-referenced-by-count":7,"title":["Venetoclax plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: an expanded access study in Japan"],"prefix":"10.1093","volume":"53","author":[{"given":"Noboru","family":"Asada","sequence":"first","affiliation":[{"name":"Okayama University Hospital Department of Hematology and Oncology, , Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Ando","sequence":"additional","affiliation":[{"name":"School of Medicine, Juntendo University Department of Hematology, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Takada","sequence":"additional","affiliation":[{"name":"Gunma Saiseikai Maebashi Hospital Leukemia Research Center, , Maebashi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikashi","family":"Yoshida","sequence":"additional","affiliation":[{"name":"National Hospital Organization Mito Medical Center Department of Hematology, , Ibaraki-machi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kensuke","family":"Usuki","sequence":"additional","affiliation":[{"name":"NTT Medical Center Tokyo Department of Hematology, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Shinagawa","sequence":"additional","affiliation":[{"name":"Hitachi General Hospital Department of Internal Medicine, , Hitachi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Yamagata University Faculty of Medicine Department of Internal Medicine III, , Yamagata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Kyushu University Graduate School of Medical Sciences Department of Medicine and Biosystemic Science, , Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroatsu","family":"Iida","sequence":"additional","affiliation":[{"name":"National Hospital Organization Nagoya Medical Center Department of Hematology, , Nagoya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuaki","family":"Dobashi","sequence":"additional","affiliation":[{"name":"The Jikei University Daisan Hospital Division of Clinical Oncology\/Hematology, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumiko","family":"Okubo","sequence":"additional","affiliation":[{"name":"AbbVie GK Department of Hematology and Cell Therapy, , Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideyuki","family":"Honda","sequence":"additional","affiliation":[{"name":"AbbVie GK Department of Hematology and Cell Therapy, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomomi","family":"Soshin","sequence":"additional","affiliation":[{"name":"AbbVie GK Department of Hematology and Cell Therapy, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuko","family":"Nishimura","sequence":"additional","affiliation":[{"name":"AbbVie GK Department of Hematology and Cell Therapy, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Tsutsui","sequence":"additional","affiliation":[{"name":"AbbVie GK Department of Hematology and Cell Therapy, , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harumi","family":"Mukai","sequence":"additional","affiliation":[{"name":"Abbvie Inc. 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