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We developed a multi\u2010institutional, single\u2010arm, prospective phase II trial, to investigate intensified conditioning with \u2018Mega\u2010Dose\u2019 decitabine (MegaDAC) following allogeneic haematopoietic cell transplantation (allo\u2010HCT) for R\/R AML. From 2019 to 2023, 70 heavily treated R\/R AML patients in active disease were consecutively enrolled. Significantly, every patient (<jats:italic>n<\/jats:italic>\u2009=\u200918) harbouring specific mutations exhibited no response to their best available target agents (BATs). Moreover, 74.3% of the enrolled patients did not reach remission following venetoclax\u2010based regimens. All patients underwent intravenous decitabine (400\u2009mg\/m<jats:sup>2<\/jats:sup>) along with busulfan and cyclophosphamide. Median follow\u2010up was 26\u2009months (8\u201365) after HCT. All engrafted patients achieved MRD negativity post\u2010HCT, with a median 3.3\u2010log reduction in recurrent genetic abnormalities. The regimen was well tolerated, without irreversible grades III\u2013IV toxicity peri\u2010engraftment. The estimated 2\u2010year CIR was 29.6% (18.4%\u201341.7%) and the est\u20102\u2010year NRM was 15.5% (7.8%\u201325.5%). The est\u20102\u2010year LFS, OS, and GRFS were 55.0% (43.5%\u201369.4%), 58.6% (47.0%\u201373.0%), and 42.9% (31.9%\u201357.6%), respectively. Multivariate analysis showed that pre\u2010HCT drug exposures had no significant impact on primary outcomes. MegaDAC is highlighted as an effective and safe option for R\/R AML in the new era of targeted therapies.<\/jats:p>","DOI":"10.1111\/bjh.19781","type":"journal-article","created":{"date-parts":[[2024,9,28]],"date-time":"2024-09-28T00:34:14Z","timestamp":1727483654000},"page":"1910-1920","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Mega\u2010dose decitabine conditioning and prophylactic donor lymphocyte infusion for patients with relapsed\/refractory <scp>AML<\/scp> with active disease at the time of allogeneic haematopoietic cell transplantation: A multicenter prospective phase <scp>II<\/scp> study"],"prefix":"10.1111","volume":"205","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6625-9523","authenticated-orcid":false,"given":"Meng","family":"Lv","sequence":"first","affiliation":[{"name":"Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for 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