Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT06181734
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06181734
Study Brief:
Protocol Section:
NCT06181734