Cytarabine, Idarubicin and Liposome-encapsulated Daunorubicin-Cytarabine, or Venetoclax, Azacitidine, and Decitabine in Treating Older Patients with Acute Myeloid Leukemia

Inclusion Criteria

• A new diagnosis of de novo, secondary or treatment-related AML, other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm
• Patients aged ≥ 60 years
• Karnofsky Performance Status >= 60%
• Subjects must be able and willingly give signed informed consent

Exclusion Criteria

• Acute promyelocytic leukemia (APL); patients with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible for the study
• Relapsed or refractory AML, who require salvage therapy
• Prior exposure to decitabine or azacitidine will be an exclusion criterion for the use of decitabine or azacitidine alone
• Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy; patients will not be excluded solely based on prior use of debulking agent; prior or current use of leukapheresis will be allowed
• Uncontrolled serious infection at the time of enrollment; infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, patients do not have signs of infection progression; progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
• Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered by the treating physician as a contraindication for initiation of chemotherapy; discussion with the principal investigator is encouraged if further clarification is required
• Ejection fraction < 45% will be an exclusion criteria for intensive chemotherapy; such patients may receive low intensity therapy
• Clinically significant kidney (e.g. glomerular filtration rate [GFR] =< 45ml/minute or creatinine of >= 2 mg/dl) or liver dysfunction (e.g. aspartate aminotransferase [AST]/alanine aminotransferase (ALT) and/or bilirubin >= 2 times upper limit of normal [ULN]) at the time of enrollment that may prevent from safely using chemotherapy; such patients may be allowed to receive low-intensity chemotherapy; patients with elevated bilirubin secondary to Gilbert syndrome will not be excluded; discussion with the principal investigator is encouraged if further clarification is required
• Any other condition that may not allow safe use of chemotherapy based on the clinical judgment of the treating oncologist