A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

• Status: Recruiting
• Trial end date: 2025-12-31
• 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(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

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

2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;

3. Patients without receiving prior therapy for AML;

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

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

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

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

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

Exclusion Criteria:

1. Acute promyeloid leukemia；

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

3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；

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.