Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2010-07-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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iOMEDICO AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jürgen Wehmeyer, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hämatologisch-onkologische Gemeinschaftspraxis
Locations
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iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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IOM-0905
Identifier Type: -
Identifier Source: org_study_id
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