Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.

Inclusion Criteria:Known and written informed consent voluntarilyAge ≥ 18 yearsNewly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:75 years or Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; Creatinine clearance >= 30 mL/min to < 45 ml/min; Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN*; alanine aminotransferase (ALT) ≤3.0×ULN*; Bilirubin≤1.5×ULN*; For subjects <75 years old, the bilirubin level can be ≤3.0×ULN; Unless due to leukemic organ involvement.Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)Life expectancy ≥ 4 weeksExclusion Criteria:History of any malignancies prior to study entry with exception noted in the protocol.Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .Participant has known active central nervous system (CNS) involvement with AML.Must not have received prior anti-AML treatment except for hydroxyurea