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
  Purpose

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


Condition
MDS
AML
CMMOL

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Progression-free-survival [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192945

Locations
Germany
iOMEDICO AG
Freiburg, Baden-Wuerttemberg, Germany, 79106
Sponsors and Collaborators
iOMEDICO AG
  More Information

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01192945     History of Changes
Other Study ID Numbers: IOM-0905
Study First Received: July 30, 2010
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by iOMEDICO AG:
Azacitidin
Vidaza
Piaza
myelodysplastic syndrome
MDS
chronic myelomonocytic leukemia
CMML
acute myeloid leukemia
AML
daily routine
concomitant antiemetic therapy
germany
non-interventional study

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014