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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT05361057
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed acute myeloid leukemia
2. Received chemotherapy within 24 months and has completed the consolidation treatment plan
3. In complete remission
4. With MRD positive: abnormal myeloid cells in bone marrow ≥ 0.1%, or NPM1 gene mutation and other fusion gene positive(RUNX 1-RUNX1T 1、CBFB-MYH11 and DEK-NUP214), the PCR quantification ≥1%.
5. Age≥ 18 years #male or female
6. ECOG-PS score 0-2
7. Aboratory tests#within 7 days before chemotherapy# 1). Serum total bilirubin≤1.5xULN# 2). Serum AST and ALT≤2.5xULN 3). Serum creatinine≤2xULN# 4). Cardiac enzymes≤2xULN 5). Ejection fraction \>50% by ECHO#
8. Written informed consent
Exclusion Criteria:
1. Hematological relapse (the proportion of blast cells in bone marrow is greater than 5%)
2. Receive hematopoietic stem cell transplantation within 4 weeks
3. APL
4. Have been treated with venetoclax in the past 6 months (who can be enrolled after stopping for more than 6 months)
5. Suffering from malignant tumors of other organs (those requiring treatment)
6. Pregnant or lactating women
7. Active heart diseases
8. Severe active infection
9. Unfit for enrollment evaluated by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05361057
Study Brief:
Protocol Section:
NCT05361057