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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT01192945
First received: July 30, 2010
Last updated: March 11, 2014
Last verified: March 2014

July 30, 2010
March 11, 2014
July 2010
July 2014   (final data collection date for primary outcome measure)
Progression-free-survival [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01192945 on ClinicalTrials.gov Archive Site
  • 2 year survival rate [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • overall response rate [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • time to treatment discontinuation [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • haematological improvement [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]
  • relative dosage of azacitidine [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]
  • liver and kidney functionality [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]
  • blood transfusion requirements [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]
  • supportive medication [ Time Frame: 2 years after LPI ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Non-interventional Study With Azacitidin (Vidaza®)
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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).

  • MDS
  • AML
  • CMMOL
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01192945
IOM-0905
Not Provided
iOMEDICO AG
iOMEDICO AG
Not Provided
Not Provided
iOMEDICO AG
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP