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Completed

NCT Number: NCT01192945

Non-interventional Study With Azacitidin (Vidaza®)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-free-survival

    Time frame: 2 years after LPI

Secondary outcomes

  1. 2 year survival rate

    Time frame: 2 years after LPI

  2. overall survival

    Time frame: 2 years after LPI

  3. overall response rate

    Time frame: 2 years after LPI

  4. time to treatment discontinuation

    Time frame: 2 years after LPI

  5. haematological improvement

    Time frame: 2 years after LPI

  6. relative dosage of azacitidine

    Time frame: 2 years after LPI

  7. liver and kidney functionality

    Time frame: 2 years after LPI

  8. blood transfusion requirements

    Time frame: 2 years after LPI

  9. supportive medication

    Time frame: 2 years after LPI

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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)

Acronym: Piaza

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 1, 2010
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.