Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

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

Details

• Lead Sponsor: Hematology department of the 920th hospital
• Treatments: Aclacinomycins; Azacitidine; Cytarabine; Lenograstim; Venetoclax

Criteria

Inclusion Criteria:

1. Patients ≥ 18 years old and ≤ 65 years old

2. Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;

3. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;

4. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN

5. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN

6. Heart function: left ventricular ejection fraction ≧45%

7. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria:

1. Other diseases；

2. AML with central nervous system (CNS) infiltration；

3. Patients have received prior CAG or VA regimen before；

4. Patients with a life expectancy <3 months

5. Patients with uncontrolled active infection;

6. HIV infection;

7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. b) An active second cancer that requires treatment within 6 months of study entry

8. Female who are pregnant, breast feeding or childbearing potential.

9. Patients deemed unsuitable for enrollment by the investigator;