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To clarify the efficacy and the safety of <jats:styled-content style=\"fixed-case\">FLAG<\/jats:styled-content>\u2010idarubicin (<jats:styled-content style=\"fixed-case\">IDA<\/jats:styled-content>) for children prospectively, we planned a multicenter phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study (<jats:styled-content style=\"fixed-case\">AML<\/jats:styled-content>\u2010R11) by the Japanese Pediatric Leukemia\/Lymphoma Study Group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with <jats:styled-content style=\"fixed-case\">AML<\/jats:styled-content> aged between 2 and 20\u00a0years old, who had the first bone marrow (<jats:styled-content style=\"fixed-case\">BM<\/jats:styled-content>) relapse or induction failure, were enrolled. The <jats:styled-content style=\"fixed-case\">FLAG<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IDA<\/jats:styled-content> regimen consisted of Flu 30\u00a0mg\/m<jats:sup>2<\/jats:sup> for 5\u00a0days, Ara\u2010C 2\u00a0g\/m<jats:sup>2<\/jats:sup> for 5\u00a0days, G\u2010<jats:styled-content style=\"fixed-case\">CSF<\/jats:styled-content> (lenograstim) 5\u00a0\u03bcg\/kg for 6\u00a0days and <jats:styled-content style=\"fixed-case\">IDA<\/jats:styled-content> 10\u00a0mg\/m<jats:sup>2<\/jats:sup> for 3\u00a0days. The primary endpoint was remission rate after therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Due to drug supply issues, the trial was suspended after the inclusion of seven eligible patients. There were six cases of early relapse within 1\u00a0year of the first remission. All seven patients completed the therapy and no early death was observed. Hematological toxicity was common, and one patient developed grade 4 non\u2010hematological toxicity of bacterial meningitis. Although only one patient with late relapse achieved complete remission, minimal residual disease was positive on both flow cytometry and <jats:italic>Wilms\u2019 tumor 1 <\/jats:italic><jats:styled-content style=\"fixed-case\">mRNA<\/jats:styled-content>. Two patients were alive in remission following hematopoietic stem cell transplantation, whereas the other five patients died of either the disease or treatment\u2010related causes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">FLAG<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IDA<\/jats:styled-content> might be tolerable for children with refractory <jats:styled-content style=\"fixed-case\">AML<\/jats:styled-content> although the efficacy should be further investigated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ped.13378","type":"journal-article","created":{"date-parts":[[2017,8,3]],"date-time":"2017-08-03T20:28:28Z","timestamp":1501792108000},"page":"1046-1052","source":"Crossref","is-referenced-by-count":8,"title":["Fludarabine, cytarabine, granulocyte colony\u2010stimulating factor and idarubicin for relapsed childhood acute myeloid 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