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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01192945

Acronym

Piaza

Enrollment

150

Registered

2010-09-01

Start date

2010-07-31

Completion date

2015-11-30

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, CMMOL, MDS

Keywords

Azacitidin, Vidaza, Piaza, myelodysplastic syndrome, MDS, chronic myelomonocytic leukemia, CMML, acute myeloid leukemia, AML, daily routine, concomitant antiemetic therapy, germany, non-interventional study

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free-survival	2 years after LPI

Secondary

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

Countries

Germany

Outcome results