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

Prior treatment

• concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
• 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.
• prior Treatments:
  • prior investigational drugs (within 30 days);
  • radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;
  • growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;
  • androgenic hormones during the previous 14 days;
  • prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least 60 days before enrolment).

Other illness

• severe renal, cardiac, liver or lung impairment;
• HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;
• clinically relevant neurological or psychiatric diseases;
• hypersensitivity (known or suspected) to AZA;

Other

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

• 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
• Life expectancy ≥3 months;
• Signed written informed consent according to ICH/EU/GCP and national local laws
• Eastern Cooperative Oncology Group Performance Status Grade of 0-2