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Five\u2010year overall survival is below 30%, which has partly been attributed to cytarabine resistance. Preclinical data suggest that the addition of hydroxyurea potentiates cytarabine efficacy by increasing ara\u2010C triphosphate (ara\u2010CTP) levels through targeted inhibition of SAMHD1.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>In this phase 1 trial, we evaluated the feasibility, safety and efficacy of the addition of hydroxyurea to standard chemotherapy with cytarabine\/daunorubicin in newly diagnosed AML patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Nine patients were enrolled and received at least two courses of ara\u2010C (1\u00a0g\/m<jats:sup>2<\/jats:sup>\/2 h b.i.d. d1\u20105, i.e., a total of 10 g\/m<jats:sup>2<\/jats:sup> per course), hydroxyurea (1\u20132 g d1\u20105) and daunorubicin (60 mg\/m<jats:sup>2<\/jats:sup> d1\u20103). The primary endpoint was safety; secondary endpoints were complete remission rate and measurable residual disease (MRD). Additionally, pharmacokinetic studies of ara\u2010CTP and <jats:italic>ex<\/jats:italic> <jats:italic>vivo<\/jats:italic> drug sensitivity assays were performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The most common grade 3\u20104 toxicity was febrile neutropenia (100%). No unexpected toxicities were observed. Pharmacokinetic analyses showed a significant increase in median ara\u2010CTP levels (1.5\u2010fold; <jats:italic>p<\/jats:italic>\u00a0=\u00a00.04) in patients receiving doses of 1 g hydroxyurea. <jats:italic>Ex vivo<\/jats:italic>, diagnostic leukaemic bone marrow blasts from study patients were significantly sensitised to ara\u2010C by a median factor of 2.1 (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.0047). All nine patients (100%) achieved complete remission, and all eight (100%) with validated MRD measurements (flow cytometry or real\u2010time quantitative polymerase chain reaction [RT\u2010qPCR]) had an MRD level &lt;0.1% after two cycles of chemotherapy. Treatment was well\u2010tolerated, and median time to neutrophil recovery &gt;1.0\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L and to platelet recovery &gt;50\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L after the start of cycle 1 was 19 days and 22\u00a0days, respectively. Six of nine patients underwent allogeneic haematopoietic stem\u2010cell transplantation (allo\u2010HSCT). With a median follow\u2010up of 18.0 (range 14.9\u201320.5) months, one patient with adverse risk not fit for HSCT experienced a relapse after 11.9\u00a0months but is now in second complete remission.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Targeted inhibition of SAMHD1 by the addition of hydroxyurea to conventional AML therapy is safe and appears efficacious within the limitations of the small phase 1 patient cohort. These results need to be corroborated in a larger study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/joim.13553","type":"journal-article","created":{"date-parts":[[2022,8,8]],"date-time":"2022-08-08T06:23:27Z","timestamp":1659939807000},"page":"925-940","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Targeting SAMHD1 with hydroxyurea in first\u2010line cytarabine\u2010based therapy of newly diagnosed acute myeloid leukaemia: Results from the HEAT\u2010AML trial"],"prefix":"10.1111","volume":"292","author":[{"given":"Martin","family":"J\u00e4dersten","sequence":"first","affiliation":[{"name":"Department of Hematology Karolinska University Hospital  Stockholm Sweden"},{"name":"Center for Hematology and Regenerative Medicine Department of Medicine, Karolinska Institutet  Stockholm 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