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

Summary

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.

Eligibility

Inclusion Criteria:

* 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

Exclusion 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

Conditions2

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