Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

Ivosidenib in Combination With Azacitidine as First-line Treatment for Adult Patients With Newly Diagnosed AML With an IDH1 R132 Mutation Who Are Not Eligible to Receive Standard Induction Chemotherapy

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

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*

  *Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose

• 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.