Open-label, randomized multicenter phase III non-inferiority study
Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high
Age 18-70 years
Previously untreated for HR-MDS
HSCT - eligible
Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);
concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
severe renal, cardiac, liver or lung impairment;
pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine.