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Clinical Trial Summary

The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany. The main questions it aims to answer are: - Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire and European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire during treatment and follow-up period - Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate) - Assessment of drug safety (all adverse events) - Description of treatment reality in detail


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06181734
Study type Observational
Source iOMEDICO AG
Contact iOMEDICO
Phone +49 761 152420
Email information@iomedico.com
Status Recruiting
Phase
Start date December 20, 2023
Completion date June 30, 2028

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