Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)

Inclusion Criteria:

1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 andhigh, and IPSS-R intermediate to very-high

2. Age 18-70 years

3. Previously untreated for HR-MDS

4. HSCT - eligible

5. Life expectancy ≥3 months;

6. Signed written informed consent according to ICH/EU/GCP and national local laws

7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2

Exclusion Criteria:

1. Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);

2. concurrent malignancy diagnosed in the past 12 months (with the exception of skinbasalioma);

3. severe renal, cardiac, liver or lung impairment;

4. pregnant or lactating or potentially fertile (both males and females), who have notagreed to avoid pregnancy during the trial period; Women of childbearing potentialand men must agree to use effective contraception during and up to 3 months aftertreatment with azacitidine.

5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;

6. clinically relevant neurological or psychiatric diseases;

7. hypersensitivity (known or suspected) to AZA;

8. prior Treatments:

9. prior investigational drugs (within 30 days);

10. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions withinthe previous 6 months;

11. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;

12. androgenic hormones during the previous 14 days;

13. prior transplantation or cytotoxic therapy, including azacitidine, AZA orchemotherapy, administered to treat MDS (a previous treatment with Lenalidomideis admitted, provided that lenalidomide had been stopped at least 60 daysbefore enrolment).