Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Inclusion Criteria: * Must be 18 years of age at the time of signing the informed consent form * MDS at IPSS Low or Int-1, or mixed MDS/MPD; either CMML with \< 10% marrow blasts or RARS-T * Patients with high or intermediate probability for response according to the predictive model (see Hellstrom-Lindberg et al, Br J Haematol 99:344-51 1997)should be refractory to EPO / darbepoetin (equivalent to \> 60 000 U of EPO / week for \> 8 weeks) followed by EPO + G-CSF for \> 8 weeks, or biosimilar drugs in equipotent doses, or EPO + G-CSF upfront for 8 weeks. Patients with low probability for response according to the predictive model, could be included without prior EPO/G-CSF treatment * Transfusion need \>4 units over the last 8 weeks, or \>8 units over the last 26 weeks. * Subject has signed the informed consent document. * Men and women of childbearing potential must use effective contraception during, and for up to 3 months after treatment. Exclusion Criteria: * Pregnant or lactating females. * Patients who are eligible for curative treatment * Expected survival less than 24 weeks. * Symptomatic thrombocytopenia / active bleeding * Patients with JAK-2 positive RARS-T if eligible for new investigational drugs * Serum biochemical values as follows 1. Serum creatinine \>2.0 mg/dL (177 micromol/L) 2. Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \>3.0 x upper limit of normal (ULN) 3. Serum total bilirubin \>1.5 mg/dL (26 micromol/L) * Uncontrolled systemic infection * Considered not capable of following the study protocol