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

iOMEDICO

Status: Completed

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Ivosidenib

Study type: Observational

Funder types: Industry

Identifiers

NCT06181734

iOM-070496

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.