Status:
COMPLETED
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
Lead Sponsor:
iOMEDICO AG
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
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 chemother...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06181734
Start Date
December 20 2023
End Date
July 30 2025
Last Update
December 9 2025
Active Locations (1)
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1
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Germany