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In this multicentre, open\u2010label, phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study, 44 patients with polycythaemia vera (<jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content>), unresponsive to the maximum tolerated doses (<jats:styled-content style=\"fixed-case\">MTD<\/jats:styled-content>) of hydroxycarbamide (<jats:styled-content style=\"fixed-case\">HC<\/jats:styled-content>), were treated with Givinostat (50 or 100\u00a0mg\/d) in combination with <jats:styled-content style=\"fixed-case\">MTD<\/jats:styled-content> of <jats:styled-content style=\"fixed-case\">HC<\/jats:styled-content>. The European LeukaemiaNet response criteria were used to assess the primary endpoint after 12\u00a0weeks of treatment. Complete or partial response was observed in 55% and 50% of patients receiving 50 or 100\u00a0mg of Givinostat, respectively. Control of pruritus was observed in 64% and 67% of patients in the 50 and 100\u00a0mg groups, respectively. The combination of Givinostat and <jats:styled-content style=\"fixed-case\">HC<\/jats:styled-content> was well tolerated: eight patients (18%) discontinued, four in each treatment arm; grade 3 adverse events were reported in one patient (4\u00b75%) in each treatment arm. The combined use of Givinostat and <jats:styled-content style=\"fixed-case\">HC<\/jats:styled-content> was safe and clinically effective in <jats:styled-content style=\"fixed-case\">HC<\/jats:styled-content>\u2010unresponsive <jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content> patients.<\/jats:p>","DOI":"10.1111\/bjh.12332","type":"journal-article","created":{"date-parts":[[2013,4,10]],"date-time":"2013-04-10T10:51:25Z","timestamp":1365591085000},"page":"688-694","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":119,"title":["A phase II study of <scp>G<\/scp>ivinostat in combination with hydroxycarbamide in patients with polycythaemia vera unresponsive to hydroxycarbamide monotherapy"],"prefix":"10.1111","volume":"161","author":[{"given":"Guido","family":"Finazzi","sequence":"first","affiliation":[{"name":"Haematology Ospedale Papa Giovanni XXIII Bergamo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro M.","family":"Vannucchi","sequence":"additional","affiliation":[{"name":"Haematology University of Florence A.O.U. 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