{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:05:52Z","timestamp":1777878352994,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Hematology"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Mutations in the\n                      <jats:italic toggle=\"yes\">FMS<\/jats:italic>\n                      -like tyrosine kinase 3 (\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      ) gene are present in approximately 30% of patients with newly diagnosed (ND) acute myeloid leukemia (AML), and are associated with worse therapy outcomes compared to the general AML population. Gilteritinib, a selective oral FLT3 inhibitor, is a promising treatment option for this patient population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>\n                      To assess the safety and efficacy of gilteritinib in combination with induction and consolidation chemotherapy in Asian patients with ND,\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      -mutated (\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      <jats:sup>mut+<\/jats:sup>\n                      ) AML.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This study was a phase I\/II open-label, single-arm study. Herein, we present the final results from phase II.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A total of 84 patients were enrolled in 33 centers across Japan, Korea, and Taiwan. All patients enrolled in phase II received induction and consolidation therapy with gilteritinib 120\u2009mg\/day plus chemotherapy (induction: \u2a7d2 cycles, idarubicin\/cytarabine once-daily; consolidation: \u2a7d4 cycles, cytarabine twice-daily) followed by maintenance with gilteritinib 120\u2009mg\/day monotherapy (\u2a7d26 cycles). The primary efficacy endpoint was the complete remission (CR) rate after induction therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The primary endpoint of CR rate after induction was 50.0% (90% CI: 40.4\u201359.6). Gilteritinib in combination with chemotherapy achieved high composite CR (CRc; 86.6%, 95% CI: 77.3\u201393.1) rates after induction. The overall survival (OS) rate at 3\u2009years was 71.6%, and the median OS was 48.2\u2009months; however, due to the immaturity of the data, the median OS should be interpreted with caution. In addition, 51.2% of patients underwent hematopoietic stem cell transplantation during the study period. The safety profile of gilteritinib was as expected, and no new safety signals were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>\n                      Induction and consolidation with gilteritinib plus chemotherapy, and maintenance with gilteritinib monotherapy were well tolerated in ND patients in Asia with\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      <jats:sup>mut+<\/jats:sup>\n                      AML and had favorable efficacy compared with historical data.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>This trial was registered with the ClinicalTrials.gov identifier NCT02310321.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20406207261419953","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T04:28:18Z","timestamp":1773289698000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["A phase I\/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis"],"prefix":"10.1177","volume":"17","author":[{"given":"Masashi","family":"Sawa","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology, Anjo Kosei Hospital, 28 Higashihirokute, Anjo-cho, Anjo, Aichi, 446-8602 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihiro","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Hematology, Kanazawa University, Ishikawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hee-Je","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary\u2019s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasushi","family":"Hiramatsu","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"June-Won","family":"Cheong","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takayuki","family":"Ikezoe","sequence":"additional","affiliation":[{"name":"Department of Hematology, Fukushima Medical University Hospital, Fukushima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoki","family":"Naoe","sequence":"additional","affiliation":[{"name":"National Hospital Organization Nagoya Medical Center, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Akashi","sequence":"additional","affiliation":[{"name":"Department of Medicine and Biosystemic Science, Kyushu University Hospital, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Morita","sequence":"additional","affiliation":[{"name":"Department of Biomedical Statistics and Biomedicine, Kyoto University Graduate School of Medicine, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanori","family":"Kosako","sequence":"additional","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development, Astellas Pharma Inc., Tokyo, Japan"},{"name":"Early Development and Translational Science, Astellas Pharma Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaki","family":"Shimura","sequence":"additional","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development, Astellas Pharma Inc., Tokyo, Japan"},{"name":"Early Development and Translational Science, Astellas Pharma Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wataru","family":"Terada","sequence":"additional","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development, Astellas Pharma Inc., Tokyo, Japan"},{"name":"Early Development and Translational Science, Astellas Pharma Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Kadokura","sequence":"additional","affiliation":[{"name":"Clinical Operations, Quantitative Sciences and China Development, Astellas Pharma Inc., Tokyo, Japan"},{"name":"Early Development and 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Cancer Stat Facts: Leukemia: Acute Myeloid Leukemia (AML). SEER https:\/\/seer.cancer.gov\/statfacts\/html\/amyl.html (2026 accessed 2 March 2026)."},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-018-0357-9"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1902688"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-024-02382-9"},{"key":"e_1_3_4_8_2","unstructured":"European Medicines Agency. Xospata [Internet] https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/xospata#authorisation-details-section (2019 accessed 2 March 2026)."},{"key":"e_1_3_4_9_2","unstructured":"U.S. Food & Drug Adminstration. FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation [Internet] https:\/\/www.fda.gov\/drugs\/fda-approves-gilteritinib-relapsed-or-refractory-acute-myeloid-leukemia-aml-flt3-mutation (2018 accessed 2 March 2026)."},{"key":"e_1_3_4_10_2","unstructured":"Report on the Deliberation Results [Internet]. Pharmaceutical Evaluation Division Pharmaceutical Safety and Environmental Health Bureau Ministry of Health Labour and Welfare. Report on the Deliberation Results https:\/\/www.pmda.go.jp\/files\/000228502.pdf (2018 accessed 2 March 2026)."},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-024-03840-x"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2018015925"},{"key":"e_1_3_4_13_2","unstructured":"National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 https:\/\/dctd.cancer.gov\/research\/ctep-trials\/trial-development (2010 accessed 2 March 2026)."},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1614359"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00464-6"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.02721"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.21037\/sci-2022-044"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2023.1086846"},{"issue":"9","key":"e_1_3_4_19_2","article-title":"FLT3 mutations in acute myeloid leukemia: unraveling the molecular mechanisms and implications for targeted therapies","volume":"15","author":"Jalte M","year":"2023","unstructured":"Jalte M, Abbassi M, El Mouhi H, et al. FLT3 mutations in acute myeloid leukemia: unraveling the molecular mechanisms and implications for targeted therapies. 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A study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes with excess blasts-2 with FLT3 mutations eligible for intensive chemotherapy (HOVON 156 AML) https:\/\/clinicaltrials.gov\/study\/NCT04027309 (2024 accessed 2 March 2026)."},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.01911"},{"key":"e_1_3_4_25_2","volume-title":"Venetoclax (VEN) and azacitidine (AZA) with gilteritinib (GILT) in patients with newly diagnosed (ND) FLT3mut+ Acute Myeloid Leukemia (AML) ineligible for intensive induction chemotherapy (chemo): interim results from the phase 1\/2 VICEROY study","author":"Altman J","unstructured":"Altman J, Perl A, Wang E, et al. Venetoclax (VEN) and azacitidine (AZA) with gilteritinib (GILT) in patients with newly diagnosed (ND) FLT3mut+ Acute Myeloid Leukemia (AML) ineligible for intensive induction chemotherapy (chemo): interim results from the phase 1\/2 VICEROY study. Presented at the 67th Annual American Society of Hematology Meeting (ASH 2025), 6\u20139 December 2025, Orlando, FL, USA."}],"container-title":["Therapeutic Advances in Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20406207261419953","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20406207261419953","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20406207261419953","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:18:15Z","timestamp":1777591095000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20406207261419953"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":24,"alternative-id":["10.1177\/20406207261419953"],"URL":"https:\/\/doi.org\/10.1177\/20406207261419953","relation":{},"ISSN":["2040-6207","2040-6215"],"issn-type":[{"value":"2040-6207","type":"print"},{"value":"2040-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]},"article-number":"20406207261419953"}}