A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia

Inclusion criteria

• Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%).
• Age ≥14 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol.
• Meet the following laboratory test requirements (assessed within 7 days prior to treatment):

• Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group;
• AST and ALT ≤2.5 × ULN for the same age group;
• Serum creatinine <2 × ULN for the same age group;
• Cardiac enzymes <2 × ULN for the same age group;
• Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range.
• Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members.

Exclusion criteria

• Acute promyelocytic leukemia with PML-RARA fusion gene.
• Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.
• Acute myeloid leukemia with BCR-ABL fusion gene.
• Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).
• Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted).
• Concurrent malignancy of other organs that requires treatment.
• Active cardiac disease, defined as one or more of the following:

• History of uncontrolled or symptomatic angina pectoris;
• Myocardial infarction within 6 months prior to study enrollment;
• History of arrhythmia requiring medication or with clinically significant symptoms;
• Uncontrolled or symptomatic congestive heart failure (> NYHA class 2).
• Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis).
• Patients deemed unsuitable for enrollment by the investigator.