Non-interventional Study With Azacitidin (Vidaza®)

Study Overview
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Brief Summary
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The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.

Official Title
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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)

Conditions
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MDS, AML, CMMOL

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free-survival |  | 2 years after LPI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 year survival rate |  | 2 years after LPI | 
| overall survival |  | 2 years after LPI | 
| overall response rate |  | 2 years after LPI | 
| time to treatment discontinuation |  | 2 years after LPI | 
| haematological improvement |  | 2 years after LPI | 
| relative dosage of azacitidine |  | 2 years after LPI | 
| liver and kidney functionality |  | 2 years after LPI | 
| blood transfusion requirements |  | 2 years after LPI | 
| supportive medication |  | 2 years after LPI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azacitidin, Vidaza, Piaza, myelodysplastic syndrome, MDS, chronic myelomonocytic leukemia, CMML, acute myeloid leukemia, AML, daily routine, concomitant antiemetic therapy, germany, non-interventional study