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

• Status: Not yet recruiting
• Trial end date: 2027-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Tong Ren Hospital
• Treatments: Azacitidine; Venetoclax

Criteria

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