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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)


N/A
18 Years
N/A
Open (Enrolling)
Both
MDS, AML, CMMOL

Thank you

Trial Information

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)


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free-survival

Outcome Time Frame:

2 years after LPI

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

IOM-0905

NCT ID:

NCT01192945

Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • MDS
  • AML
  • CMMOL
  • Azacitidin
  • Vidaza
  • Piaza
  • myelodysplastic syndrome
  • MDS
  • chronic myelomonocytic leukemia
  • CMML
  • acute myeloid leukemia
  • AML
  • daily routine
  • concomitant antiemetic therapy
  • germany
  • non-interventional study
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders

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