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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT06232694
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
* Age between 18 and 60 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
* Cardiac ultrasound LVEF ≥ 45%.
* Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
* Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration).
* Signed informed consent form.
Exclusion Criteria:
* Acute promyelocytic leukemia (APL).
* Relapsed/refractory AML patients.
* AML patients with known involvement of the central nervous system (CNS).
* Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
* Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
* Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity.
* Participants with chronic respiratory disease requiring continuous oxygen therapy.
* Patients unable to take oral medications or with malabsorption syndrome.
* Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
* Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06232694
Study Brief:
Protocol Section:
NCT06232694