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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06874257
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject has a new diagnosis of AML according to World Health Organization 2022 criteria
* Subject is ineligible for intensive induction chemotherapy according to investigator assessment
* Subject will undergo front-line treatment with azacitidine and venetoclax according to normal clinical practice
* Subject providing signed written informed consent according to ICH/EU/GCP and national local laws
For healthy donors:
* Age ≥ 18 years
* Subject providing signed written informed consent according to ICH/EU/GCP and national local laws
Exclusion Criteria:
For patients:
* Subject has acute promyelocytic leukemia
* Subject has known AML with central nervous system involvement
* Subject has not initiated treatment with azacitidine and venetoclax
For healthy donors:
None
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06874257
Study Brief:
Protocol Section:
NCT06874257