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.
Parallel
Azacitidine
Drug75mg/mq/day subcutaneously for 7 days every 28 days
Standard Chemotherapy
Drug1. cycle (induction): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 60 mg/mq iv day 1-3) 2. cycle (consolidation): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 45 mg/mq iv day 1-3)
Allogeneic stem cell transplantation
Procedure/SurgeryAllogeneic stem cell transplantation
Feasibility of HSCT in terms of proportion of patients who receive HSCT of the total number of randomized patients
Split patients in two categories: the feasibility of HSCT (ITT) in patients with HR-MDS with a proportion of bone marrow blasts below 10% and in patients with a proportion of BM blasts equal or greater than 10%.
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