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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05662956
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years old and ≤ 65 years old
2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;
3. Patients without receiving prior therapy for AML;
4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
7. Heart function: left ventricular ejection fraction ≧45%
8. Patients must participate in this clinical trial voluntarily and sign an informed consent form.
Exclusion Criteria:
1. Acute promyeloid leukemia；
2. AML with central nervous system (CNS) infiltration；
3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
4. Patients with a life expectancy \<3 months
5. Patients with uncontrolled active infection;
6. HIV infection;
7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment; b) An active second cancer that requires treatment within 6 months of study entry.
8. Female who are pregnant, breast feeding or childbearing potential.
9. Patients deemed unsuitable for enrollment by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05662956
Study Brief:
Protocol Section:
NCT05662956