Piaza - Non-interventional Study on the Efficacy and Safety of Azacitidin (Vidaza®) in Patients With Myelodysplastic Syndromes (MDS, INT-2 or High Risk), AML (WHO 20-30% Blasts), or CMMoL (10-29% Bone Marrow Blasts Without Myeloproliferative Disorder)
Inclusion Criteria:
- Patients who are not eligible for haematopoietic stem cell transplantation, who are
at least 18 years old (no age limit to top) and who have one of the following
diseases:
- myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according
to the International Prognostic Scoring System (IPSS)
- chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without
myeloproliferative disorder
- acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia
according to classification of the World Health Organisation (WHO).
Exclusion Criteria:
- Contraindication according to the summary of product characteristics of Vidaza®
- Signed patient informed consent form is not available
- Patients with advanced malignant hepatic tumors
- Pregnant or nursing women, men and women (of childbearing age) who are unwilling to
apply a reliable method of contraception during and up to three months after
treatment with Azacitidine
- Necessary or planned treatment with other systemic cytostatics
- Known medical history of severe decompensatoric cardiac insufficiency
- Medical history of clinically unstable cardiac or pulmonary disease
- Known or suspected hypersensitivity to azacitidine or mannitol