A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Korábbi kezelés

• History of any malignancies prior to study entry with exception noted in the protocol.
• Must not have received prior anti-AML treatment except for hydroxyurea

Más betegség

• Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .

Egyéb

• Participant has known active central nervous system (CNS) involvement with AML.

• Known and written informed consent voluntarily
• Age ≥ 18 years
• Newly 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 .
• patients who are suitable for intensive chemotherapy but refuse it
• 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 weeks