Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Inclusion criteria

• Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
• Age ≥ 14 years, male or female.
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
• Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):

i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.

ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine < 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes < 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).

Exclusion criteria

• Acute promyelocytic leukemia with PML::RARA fusion gene.
• Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
• Acute myeloid leukemia with BCR::ABL1 fusion gene.
• Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
• Concurrent active malignancy of other organs (requiring treatment).
• Active cardiac disease, defined as one or more of the following:

i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.

iv. Uncontrolled or symptomatic congestive heart failure (> New York Heart Association [NYHA] Class 2).

• Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.