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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07407660
Eligibility Criteria:
Inclusion Criteria:
1. Patients with newly diagnosed acute myeloid leukemia who meet the WHO 2022 criteria.
2. Meeting one of the following conditions:
1. Aged ≥ 60 years;
2. aged ≥ 18 years and \< 60 years, with one or more of the following comorbidities that render the subject unsuitable for intensive induction therapy:
* Complicated with congestive heart failure, or left ventricular ejection fraction ≤ 50%, or a history of chronic stable angina pectoris;
* A history of pulmonary disease, with carbon monoxide diffusing capacity of the lung (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%;
* Creatinine clearance rate \< 45 mL/min (calculated by the \*\*Cockcroft-Gault formula\*\*);
* Total bilirubin \> 1.5 × upper limit of normal;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≥ 2;
* Any other comorbidities judged by the investigator to contraindicate intensive induction therapy.
3. Received induction therapy with the azacitidine plus venetoclax regimen (azacitidine for injection: 75 mg/m² subcutaneously on Days 1-7; venetoclax tablets: 100 mg on Day 1, 200 mg on Day 2, and 400 mg once daily starting on Day 3) for 12-14 days. Dose adjustment of venetoclax shall be performed if combined with strong or moderate CYP3A/P-gp inhibitors.
4. Completed risk stratification assessment per the ELN 2022 criteria.
5. Signed the informed consent form.
Exclusion Criteria:
1. Diagnosis of acute promyelocytic leukemia, AML with t(8;21)(q22;q22.1)/ RUNX1::RUNX1T1 translocation, or blast crisis of chronic myeloid leukemia (CML).
2. Prior treatment with venetoclax before the diagnosis of acute myeloid leukemia.
3. A history of allogeneic hematopoietic stem cell transplantation.
4. Severe hepatic or renal impairment, defined by the presence of any of the following abnormalities: aspartate aminotransferase (AST) \> 2.5 × ULN; alanine aminotransferase (ALT) \> 2.5 × ULN; creatinine clearance rate \< 30 mL/min (calculated by the Cockcroft-Gault formula); or total bilirubin \> 3 × ULN.
5. Presence of acute active infection requiring intravenous systemic therapy.
6. Presence of active malignant tumors requiring antineoplastic treatment.
7. Presence of active autoimmune diseases requiring treatment with prednisone ≥ 15 mg/day or equivalent doses of other glucocorticoids, or any other immunosuppressive agents.
8. Inability to swallow tablets, or presence of diseases significantly impairing gastrointestinal function (e.g., malabsorption syndrome, gastrectomy or enterectomy, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete intestinal obstruction).
9. Pregnant or lactating female subjects.
10. Subjects judged by the investigator to be unable to comply with the protocol due to uncontrollable medical, psychological, familial, social, or geographic conditions; or those who are unwilling or unable to follow the required procedures of the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07407660
Study Brief:
Protocol Section:
NCT07407660