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

NCT ID: NCT06181734

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-07-30

Brief 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

Conditions

Acute Myeloid Leukemia (AML)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Ivosidenib

inhibitor of mutant IDH1

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

iOM-070496

Identifier Type: -

Identifier Source: org_study_id