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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05304156
Eligibility Criteria:
Inclusion Criteria:
* aged ≥18 years old,
* have a newly diagnosed AML according to WHO criteria
o patients with AML related to prior chemotherapy or radiotherapy for another cancer will be eligible,
* have signed the informed consent form of the e-THEMA observatory trial
* have ≥10% blasts (blasts+myeloblasts) on the peripheral blood smear at screening,
* have ≥20% blasts on the bone marrow smear at screening,
* have not received any treatment for AML except for hydroxyurea and/or 6-mercaptopurine and steroids
o Patients having previous treatments for antecedent myeloid neoplasms including hypomethylating agents remain eligible,
* Eligible to intensive chemotherapy, due to general health status,
* ECOG performance status ≤ 2,
* Patient is planned to receive anthracycline (daunorubicin \[DNR\] or idarubicine \[IDA\]) - cytarabine 7+3 with or without gemtuzumab ozogamycin (GO) or midostaurine, or CPX-351 as first induction course,
* Weighing 50 kg or more (compliance to Loi Jardé for PB sampling),
* Written informed consent obtained prior to any screening procedures,
* Eligible for National Health Insurance in France.
Exclusion Criteria:
* Suspected or proven acute promyelocytic leukemia based on morphology, karyotype or molecular assay,
* Failure to perform bone marrow aspiration at diagnosis,
* Unstable angina, New York Heart Association (NYHA) class 3 or 4 congestive heart failure,
* Prior anthracycline exposure more than 360 mg/m²,
* Previous therapy for AML with any other investigational agent or cytotoxic drug, within 28 days before starting treatment. Only hydroxyurea is permitted for the control of blood counts. Treatments for an antecedent myeloid neoplasm (MDS or MPN) are not considered as exclusion criteria.
* Women who are pregnant or breastfeeding.
* Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.
* Enrolment in a clinical trial which could compromise participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05304156
Study Brief:
Protocol Section:
NCT05304156