Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Will be estimated using the Kaplan-Meier method.

Defined for only patients achieving complete remission (CR), or CR with incomplete hematologic recovery (CRi). Will be estimated using the Kaplan-Meier method.

Will be estimated using the Kaplan-Meier method.

Will be estimated with cumulative incidence curves with death without relapse analyzed a competing event. Response per 2017 European LeukemiaNet (ELN) guidelines will be tabulated and exact 95% confidence intervals will be calculated.

MRDneg CR rates will be tabulated by genomic subgroups within randomized arms and pooling arms. Rates across arms will be compared using Fisher's exact test. All p-values reported will be nominal.

Will be analyzed using National Cancer Institute Common Terminology Criteria for Adverse Events version (v) 5.0

Will be reported every DSMC cycle for the 7+3+venetoclax, (daunorubicin and cytarabine) liposome+venetoclax, and 7+3 arms. Median time to count recovery more than 7 days longer on either of the 7+3+venetoclax and (daunorubicin and cytarabine liposome+venetoclax arms compared to the 7+3 arm will be used a threshold to terminate accrual to an arm due to increased toxicity.

Will be assessed by death due to any cause between experimental arms and the 7+3 arm will be reported for each arm every DSMC cycle. Fisher's exact will be used to compare observed rates. A one-sided p-value < 0.05 indicating increased early mortality rates in an experimental arm will be a threshold for termination of accrual to an arm due to increased early mortality.