Status:
COMPLETED
Non-interventional Study With Azacitidin (Vidaza®)
Lead Sponsor:
iOMEDICO AG
Conditions:
MDS
AML
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01192945
Start Date
July 1 2010
End Date
November 1 2015
Last Update
November 13 2015
Active Locations (1)
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1
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106