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

November 12, 2015 updated by: iOMEDICO AG

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)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • iOMEDICO AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are not suitable for transplantation of hematopoietic stem cells and 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Principal Investigator: Jürgen Wehmeyer, Dr., Hämatologisch-Onkologische Gemeinschaftspraxis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-0905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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