Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy

Justin Loke, Marlen Metzner, Rebecca Boucher, Aimee Jackson, Louise Hopkins, Jiri Pavlu, Eleni Tholouli, Mark Drummond, Andy Peniket, Rebecca Bishop, Sonia Fox, Paresh Vyas, Charles Craddock

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Abstract

Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next-generation sequencing studies demonstrated important insights into therapy resistance.

Original languageEnglish
JournalBritish Journal of Haematology
Early online date6 Sept 2021
DOIs
Publication statusE-pub ahead of print - 6 Sept 2021

Bibliographical note

© 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.

Keywords

  • acute myeloid leukaemia
  • clinical trial
  • early phase
  • hypomethylating agent
  • refractory
  • relapsed

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