Overview
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
Eligibility
Inclusion Criteria:
- Age 18 years or older.
- Newly diagnosed Acute Myeloid Leukemia (AML).
- Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation.
- Not eligible to receive standard induction chemotherapy.
- Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC.
- Signed written informed consent before start of study treatment.
- For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language
- Other criteria according to current SmPC.
Exclusion Criteria:
- Participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period.
- Patients unable to consent
- Other contraindications according to current SmPC.