Clinical Study Protocol for the Treatment of Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia With KMT2A Gene Abnormalities Using VHEA(Venetoclax With Homoharringtonine,Etoposide,Cytarabine)
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.
• 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.