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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT06744556
Eligibility Criteria:
Inclusion Criteria:
1. Conforming to the diagnostic criteria of AML or MDS/AML by WHO (2022) or ICC.
2. Age ≥ 60 years and ≤ 75 years, regardless of gender.
3. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) is 0 - 2.
4. Meeting the requirements of the following laboratory examination indicators (performed within 7 days before treatment):
1\) Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of normal for the same age group; 3) Serum creatinine \< 2 times the upper limit of normal for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of normal for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. The informed consent form must be signed before the initiation of all specific research procedures. It should be signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form should be signed by the legal guardian or an immediate family member of the patient.
Exclusion Criteria:
1. Acute promyelocytic leukemia accompanied by the PML-RARA fusion gene
2. Acute myeloid leukemia accompanied by the RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
3. Acute myeloid leukemia accompanied by the BCR-ABL fusion gene
4. Retreated patients (referring to those who have previously undergone induction chemotherapy but can receive hydroxyurea for cytoreduction).
5. Patients concurrently suffering from malignant tumors in other organs (requiring treatment).
6. Active cardiac diseases, defined as one or more of the following:
1\) Uncontrolled or symptomatic angina pectoris history; 2) Myocardial infarction less than 6 months from the time of enrollment in the study; 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Grade 2);
7\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).
8\. Those considered ineligible for enrollment by the researcher.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT06744556
Study Brief:
Protocol Section:
NCT06744556