Non-interventional Study With Azacitidin (Vidaza®) (Piaza)

iOMEDICO

Status: Completed

Conditions: CMMOL; AML; MDS

Study type: Observational

Funder types: Industry

Identifiers

NCT01192945

IOM-0905

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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