Non-interventional Study With Azacitidin (Vidaza®)

NCT ID: NCT01192945

Last Updated: 2015-11-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-11-30

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.

Detailed Description

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Conditions

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MDS AML CMMOL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Other Identifiers

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IOM-0905

Identifier Type: -

Identifier Source: org_study_id

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