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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT06225128
Eligibility Criteria:
Inclusion Criteria:
* be ≥18 years old,
* have a newly diagnosed AML according to ICC 2022 criteria,
* patients with AML related to prior chemotherapy or radiotherapy for another cancer will be eligible,
* patients with MDS/AML per ICC 2022 criteria will be eligible,
* have signed the informed consent form of the eTHEMA observatory trial
* have ≥10% blasts on the bone marrow smear at screening,
* have not received any treatment for AML except for hydroxyurea and/or steroids,
* Patients having previously received hypomethylating agents for an antecedent myelodysplastic syndrome are ineligible,
* be eligible to AZA/VEN or AZA/IVO therapy, due to general health status,
* have an ECOG performance status ≤ 2,
* be planned to receive azacitidine and venetoclax (AZA/VEN) or azacitidine and ivosidenib (AZA/IVO) as frontline therapy,
* weigh ≥ 40 kg (compliance to Loi Jardé for PB sampling),
* have provided written informed consent obtained prior to any screening procedures
Exclusion Criteria:
At screening, patients must NOT:
* have suspected or proven acute promyelocytic leukemia based on morphology, karyotype or molecular assay, including APL with non-PML::RARA rearrangements,
* have suspected or proven AML with t(9;22)(q34.1;q11.2)/BCR::ABL1 based on karyotype or molecular assay,
* have myeloid sarcoma,
* have failed to perform bone marrow aspiration at screening,
* have received previous therapy for AML with any investigational agent or cytotoxic drug, within 28 days before starting treatment. Only hydroxyurea is permitted for the control of blood counts. Aside from hypomethylating agents, other treatments for an antecedent myeloid neoplasm (MDS or MPN) are not considered as exclusion criteria,
* be pregnant or breastfeeding (for women),
* present any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study,
* be enrolled in a clinical trial which could compromise participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06225128
Study Brief:
Protocol Section:
NCT06225128