Clinical trial NCT01192945: Non-interventional Study With Azacitidin (Vidaza®)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MDS
AML
CMMOL
Keywords: Azacitidin
Vidaza
Piaza
myelodysplastic syndrome
MDS
chronic myelomonocytic leukemia
CMML
acute myeloid leukemia
AML
daily routine
concomitant antiemetic therapy
germany
non-interventional study
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility 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

Primary outcomes:
measure: Progression-free-survival
timeFrame: 2 years after LPI
Secondary outcomes:
measure: 2 year survival rate
timeFrame: 2 years after LPI
measure: overall survival
timeFrame: 2 years after LPI
measure: overall response rate
timeFrame: 2 years after LPI
measure: time to treatment discontinuation
timeFrame: 2 years after LPI
measure: haematological improvement
timeFrame: 2 years after LPI
measure: relative dosage of azacitidine
timeFrame: 2 years after LPI
measure: liver and kidney functionality
timeFrame: 2 years after LPI
measure: blood transfusion requirements
timeFrame: 2 years after LPI
measure: supportive medication
timeFrame: 2 years after LPI
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO AG
state: Baden-Wuerttemberg
Study officials:
affiliation: Hämatologisch-onkologische Gemeinschaftspraxis
name: Jürgen Wehmeyer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: