Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
Trial Parameters
Brief Summary
Open-label, randomized multicenter phase III non-inferiority study
Eligibility Criteria
Inclusion Criteria: 1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, 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 skin basalioma); 3. severe renal, cardiac, liver or lung impairment; 4. 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. 5. HIV infection; active, uncontrolled HCV or HBV infections or liver c