Safety And Clinical Activity Of Combined Romidepsin And Azacitidine Therapy In High Risk Acute Myeloid Leukemia: Preliminary Results Of The Romaza Trial

Introduction: Azacitidine (AZA) represents an important advance in the management of patients with acute myeloid leukemia (AML) in whom intensive chemotherapy (IC) is contra-indicated. However complete response (CR) rates are low and disease progression is inevitable. Romidepsin (ROM) is a potent Class I histone deacetylase inhibitors (HDACi) which demonstrates synergistic anti-leukemic activity with AZA in vitro and represents a plausible strategy by which its clinical activity can be increased. Despite this, the clinical impact of co-administration of ROM to AZA has not been evaluated in myeloid disorders. We therefore wished to both establish the maximum tolerated dose (MTD) of combined AZA/ROM therapy and determine the clinical activity of this novel combination in high risk AML.