Non-interventional Study With Azacitidin (Vidaza®)

AML Clinical Trial

— Piaza  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192945
• Other study ID #: IOM-0905
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: November 12, 2015
• Start date: July 2010
• Est. completion date: November 2015

Study information

• Verified date: August 2015
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AML
• CMMOL
• MDS
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Preleukemia

Locations

Country	Name	City	State
Germany	iOMEDICO AG	Freiburg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free-survival		2 years after LPI	No
Secondary	2 year survival rate		2 years after LPI	No
Secondary	overall survival		2 years after LPI	No
Secondary	overall response rate		2 years after LPI	No
Secondary	time to treatment discontinuation		2 years after LPI	No
Secondary	haematological improvement		2 years after LPI	Yes
Secondary	relative dosage of azacitidine		2 years after LPI	No
Secondary	liver and kidney functionality		2 years after LPI	Yes
Secondary	blood transfusion requirements		2 years after LPI	Yes
Secondary	supportive medication		2 years after LPI	Yes