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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 publication




Journal article


Br J Haematol

Publication Date





368 - 373


acute myeloid leukaemia, clinical trial, early phase, hypomethylating agent, refractory, relapsed, Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Azacitidine, Clinical Decision-Making, Cytogenetic Analysis, Depsipeptides, Disease Management, Disease Susceptibility, Female, Humans, Leukemia, Myeloid, Acute, Male, Molecular Targeted Therapy, Prognosis, Treatment Outcome, Young Adult