NCT06181734Completed
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
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 8 (actual)
- First submitted
- 27 Nov 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- iOMEDICO AG
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06181734
What you commit to
- Study type: Observational
- Participants enrolled: 8
- From 20 Dec 2023 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Patients unable to consent
- Other contraindications according to current SmPC.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Praxis für interdisziplinäre Onkologie & Hämatologie Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.