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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT06744504
Eligibility Criteria:
Inclusion Criteria:
1. AML conforming to WHO (2022) or ICC standards
2. Possessing the RUNX1::RUNX1T1 fusion gene
3. Age ranging from 14 to 60 years old, regardless of gender.
4. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) being 0 - 2.
5. Meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment):
1\) Total bilirubin ≤ 1.5 times the upper limit of the normal value for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of the normal value for the same age group; 3) Serum creatinine \< 2 times the upper limit of the normal value for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of the normal value for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. An informed consent form must be signed before the commencement of all specific research procedures, either by the patient themselves or their immediate relatives. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate relatives of the patient.
Exclusion Criteria:
1. Acute promyelocytic leukemia accompanied by PML-RARA fusion gene.
2. Acute myeloid leukemia featuring BCR-ABL fusion gene.
3. Patients undergoing retreatment (but can receive cytoreductive therapy with hydroxyurea and cytarabine).
4. Individuals concurrently having malignant tumors in other organs (requiring treatment).
5. Active cardiac disorders, defined as one or more of the following:
1\) A history of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months from study enrollment; 3) A history of significant arrhythmia requiring medication or presenting with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Class 2)
6\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).
7\. Individuals deemed ineligible for enrollment by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
60 Years
Study:
NCT06744504
Study Brief:
Protocol Section:
NCT06744504