Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML

Summary

This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.

Eligibility

Inclusion Criteria:

* Age between 18 and 75 years, regardless of gender.
* Diagnosis of AML (excluding APL) according to the 2022 World Health Organization (WHO) diagnostic criteria.
* ECOG performance status of 0-2.
* For female participants of childbearing potential or male participants with female partners of childbearing potential, effective contraceptive measures must be taken throughout the entire treatment period and for 6 months after the treatment period.
* Expected survival of at least 3 months.
* Ability to understand and willingness to participate in the study, and signing an informed consent form.

Exclusion Criteria:

* Acute promyelocytic leukemia (M3 subtype).
* Central nervous system leukemia.
* Severe uncontrolled infection or other major diseases.
* Heart failure: Ejection fraction (EF) \< 50%, New York Heart Association (NYHA) class II or above.
* Impaired liver or kidney function: Serum total bilirubin ≥ 2.0 mg/dl, AST ≥ 3 times the upper limit of normal, serum creatinine clearance rate (Ccr) ≥ 50 ml/min, arterial oxygen saturation (SpO2) \< 92%.
* Human immunodeficiency virus (HIV) positive.
* Active hepatitis B or C.
* Pregnant or lactating women.
* Other conditions in which the investigator deems the participant unsuitable for the study.

Conditions2

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