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Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1–2 study by Alexander E Perl; Jessica K Altman; Jorge Cortes; Catherine Smith; Mark Litzow; Maria R Baer; David Claxton; Harry P Erba; Stan Gill; Stuart Goldberg; Joseph G Jurcic; Richard A Larson; Chaofeng Liu; Ellen Ritchie; Gary Schiller; Alexander I Spira; Stephen A Strickland; Raoul Tibes; Celalettin Ustun; Eunice S Wang; Robert Stuart; Christoph Röllig; Andreas Neubauer; Giovanni Martinelli; Erkut Bahceci; Mark Levis is a Medicine article available to read on EtoBox.

What is Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1–2 study about?

## Background: Internal tandem duplication mutations in flt3 are common in acute myeloid leukaemia and are associated with rapid relapse and short overall survival. the clinical benefit of flt3 inhibitors in patients with acute myeloid leukaemia has been limited by rapid generation of resistance mutations, particularly in codon asp835 (d835). we aimed to assess the highly selective oral flt3 inhibitor gilteritinib in patients with relapsed or refractory acute myeloid leukaemia. ## Methods: In this phase 1-2 trial, we enrolled patients aged 18 years or older with acute myeloid leukaemia who either were refractory to induction therapy or had relapsed after achieving remission with previous treatment. patients were enrolled into one of seven dose-escalation or dose-expansion cohorts assigned to receive once-daily doses of oral gilteritinib (20 mg, 40 mg, 80 mg, 120 mg, 200 mg, 300 mg, or 450 mg). cohort expansion was based on safety and tolerability, flt3 inhibition in correlative assays, and antileukaemic activity. although the presence of an flt3 mutation was not an inclusion criterion, we required ten or more patients with locally confirmed flt3 mutations (flt3) to be enrolled in e

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Author

Alexander E Perl; Jessica K Altman; Jorge Cortes; Catherine Smith; Mark Litzow; Maria R Baer; David Claxton; Harry P Erba; Stan Gill; Stuart Goldberg; Joseph G Jurcic; Richard A Larson; Chaofeng Liu; Ellen Ritchie; Gary Schiller; Alexander I Spira; Stephen A Strickland; Raoul Tibes; Celalettin Ustun; Eunice S Wang; Robert Stuart; Christoph Röllig; Andreas Neubauer; Giovanni Martinelli; Erkut Bahceci; Mark Levis

Publisher

The Lancet; Elsevier ; The Lancet Publishing Group; Elsevier BV (ISSN 1470-2045)

Published

2017

Language

EN

Field

Medicine (Health Sciences)