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We conducted a phase I\/II open\u2010label study (NCT04989335) to evaluate the safety and efficacy of Bis\/Clo\/Flu in relapsed\/refractory AML. Twenty\u2010one patients (median age: 47\u2009years, 55% female) received Flu (10\u2009mg\/m<jats:sup>2<\/jats:sup>), Clo (30\u2009mg\/m<jats:sup>2<\/jats:sup>) and Bis (250\u2009mg\/m<jats:sup>2<\/jats:sup>) intravenously for 4\u2009days. Sixteen had relapsed post\u2010allogeneic stem cell transplantation, and six had extramedullary disease (EMD). Liver toxicity occurred in 10 patients but resolved. No significant cardiac toxicity was observed. Efficacy was assessable in 15 patients, while in six patients, it could not be evaluated due to early non\u2010relapse mortality occurring within 30\u2009days of treatment initiation, before the first post\u2010treatment assessment. Six of the 15 patients responded: five achieved complete remission, and one with EMD achieved a partial remission, yielding a 40% response rate. Responses were transient, but six patients, including four undergoing second allo\u2010HSCTs, proceeded to allo\u2010HSCT within 1\u20133\u2009months post\u2010treatment. The Bis\/Clo\/Flu regimen demonstrated a tolerable safety profile and potential as a bridging therapy in high\u2010risk, heavily pretreated AML.<\/jats:p>","DOI":"10.1111\/bjh.70035","type":"journal-article","created":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T09:34:09Z","timestamp":1754040849000},"page":"1425-1434","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bisantrene in combination with fludarabine and clofarabine as salvage therapy for adult patients with refractory or relapsed acute myeloid leukaemia (<scp>AML<\/scp>)\u2014An open\u2010label, phase I\/<scp>II<\/scp> study"],"prefix":"10.1111","volume":"207","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0627-5502","authenticated-orcid":false,"given":"Ivetta","family":"Danylesko","sequence":"first","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8782-6160","authenticated-orcid":false,"given":"Avichai","family":"Shimoni","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abraham","family":"Avigdor","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9175-8551","authenticated-orcid":false,"given":"Meirav","family":"Kedmi","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Amitai","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1589-9189","authenticated-orcid":false,"given":"Noga","family":"Shem\u2010Tov","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronit","family":"Yerushalmi","sequence":"additional","affiliation":[{"name":"Division of Hematology Sheba Tel Hashomer Medical Center  Ramat Gan Israel"},{"name":"School of Medicine Faculty of Medical and Health Sciences, Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Borje S.","family":"Andersson","sequence":"additional","affiliation":[{"name":"Department of Stem Cell Transplantation &amp; 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