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Patients participated in either part of the study or in both parts sequentially. In the initial part, decitabine was administered intravenously at doses of 10\u2013120\u00a0mg\/m<jats:sup>2<\/jats:sup>\u00a0per d for 5\u00a0d every other week in cycles of 28\u00a0d. In the combination part, patients were treated on the first 5\u00a0d of Hyper\u2010<jats:styled-content style=\"fixed-case\">CVAD<\/jats:styled-content> with intravenous decitabine at 5\u201360\u00a0mg\/m<jats:sup>2<\/jats:sup>\u00a0per d. A total of 39 patients received treatment in the study: 14 in the first part only, 16 sequentially in both parts and 9 in the second part only. Decitabine was tolerated at all doses administered, and grade 3 or 4 toxic effects included non\u2010life\u2010threatening hepatotoxicity and hyperglycaemia. Induction of <jats:styled-content style=\"fixed-case\">DNA<\/jats:styled-content> hypomethylation was observed at doses of decitabine up to 80\u00a0mg\/m<jats:sup>2<\/jats:sup>. Some patients who had previously progressed on Hyper\u2010<jats:styled-content style=\"fixed-case\">CVAD<\/jats:styled-content> alone achieved a complete response when decitabine was added. Decitabine alone or given with Hyper\u2010<jats:styled-content style=\"fixed-case\">CVAD<\/jats:styled-content> is safe and has clinical activity in patients with advanced <jats:styled-content style=\"fixed-case\">ALL<\/jats:styled-content>.<\/jats:p>","DOI":"10.1111\/bjh.13050","type":"journal-article","created":{"date-parts":[[2014,7,26]],"date-time":"2014-07-26T07:27:21Z","timestamp":1406359641000},"page":"356-365","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["Safety and clinical activity of 5\u2010aza\u20102\u2032\u2010deoxycytidine (decitabine) with or without Hyper\u2010<scp>CVAD<\/scp> in relapsed\/refractory acute lymphocytic leukaemia"],"prefix":"10.1111","volume":"167","author":[{"given":"Christopher B.","family":"Benton","sequence":"first","affiliation":[{"name":"Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston TX 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