Venetoclax 100 mg d1，200 mg d2，400 mg d3-28；: VAG in the induction phase of the ND-AML treatment protocol
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Complete Remission (CR) — The period of 2 months from the start of treatment. A. No symptoms or signs of leukemia cell infiltration, normal or near-normal life; B. Blood counts: Hb ≥ 100g/L (males) or ≥ 90g/L (females and children), absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L. No leukemia cells in peripheral blood leukocyte classification; C. Bone marrow morphology: Less than or equal to 5% of myeloblasts (type I + type II) (primitive monocytes + immature monocytes or primitive lymphocytes + immature lymphocytes), normal red blood cells and megakaryocytes; D. No extramedullary leukemia (no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular masses, central nervous system involvement).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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