Inclusion criteria, exclusion criteria and study summary
A multicentre,phase II,randomised (2:1) clinical trial of ASTX727 compared to best supportive care (BSC) +/- hydroxycarbamide in adult patients with MDS/Overlap syndromes including CMML. A total of 75 patients will be recruited over a 2 year period from across the network of UK TAP sites. Randomisation will be stratified by (i) presence or absence of proliferative disease (defined by WHO criteria as a white cell count ≥ or < 13 x109/L); and (ii) time from diagnosis,to extend eligibility to both newly diagnosed and longer established patients. At screening treating physicians will declare in advance a proposed BSC approach for that patient,to be employed in the event of randomisation to the BSC arm. The main aim of the study is to compare the overall response rate of ASTX727 vs best supportive care +/- hydroxycarbamide.