Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

Summary

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

Eligibility

Inclusion Criteria:

* Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Expected survival time of at least 3 months.
* Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min.
* No other significant contraindications to chemotherapy as determined by the physician;
* Capable of understanding and willing to sign the informed consent form for this study.

Exclusion Criteria:

* Presence of other malignancies;
* Underwent cardiac vascular intervention or stent placement within 12 months prior to signing the informed consent, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease;
* Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding;
* Pregnant or lactating women;
* Participation in any other clinical study within 3 months prior to signing the informed consent;
* Any other condition deemed unsuitable for participation in this study by the investigator.

Conditions2

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