Non-interventional Study With Azacitidin (Vidaza®)

Completed

• Conditions: MDS; AML; CMMOL

• Registration Number: NCT01192945
• Lead Sponsor: iOMEDICO AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Primary Completion: 2014-12
• Status Verified: 2015-08
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free-survival	2 years after LPI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

iOMEDICO AG; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany