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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT06483906
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 55 years, inclusive, regardless of gender.
2. Diagnosed with AML (excluding APL) according to the 2022 International Consensus Classification (ICC) for AML \[1\].
3. Evaluated as intermediate/high-risk AML based on the 2022 ELN AML guidelines (see Appendix 1).
4. No prior treatment for acute leukemia, including hypomethylating agents used for leukemia or myelodysplastic syndromes (MDS), except for hydroxyurea.
5. Patients must have a suitable hematopoietic stem cell donor.
6. Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
7. ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
8. Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
1. Serum creatinine ≤ 1.5x ULN (the upper limit of normal);
2. Cardiac function: Ejection fraction ≥ 50%;
3. Baseline oxygen saturation \> 92%;
4. Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN;
5. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
9\) Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
1. Acute promyelocytic leukemia.
2. Presence of extramedullary disease manifestations at diagnosis or during treatment, including central nervous system involvement.
3. History of malignancies other than myeloid neoplasms within the past 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell carcinoma, squamous cell carcinoma of the skin, and localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
4\) ECOG \> 2. 5) HCT-CI score ≥ 3. 6) Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
7\) Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.
8\) Conditions requiring treatment such as grade 2 or higher seizures, paralysis, aphasia, recent severe cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.
9\) HIV-infected individuals. 10) Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
Patients at risk of HBV reactivation, are defined as those who are positive for hepatitis B surface antigen or core antibody without receiving antiviral therapy.
11\) History of autoimmune diseases. 12) Pregnant or breastfeeding women. 13)Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06483906
Study Brief:
Protocol Section:
NCT06483906