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Recruiting
NCT05662956
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients
Conditions: Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE1, PHASE2
Enrollment: 62
Sponsor: Hematology department of the 920th hospital
Location: China
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).
Eligibility Criteria
Inclusion Criteria:Patients ≥ 18 years old and ≤ 65 years oldNewly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;Patients without receiving prior therapy for AML;Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULNRenal function:Ccr(Creatinine Clearance Rate) ≧30 ml/min; Scr (serum creatinine) ≦2 ULNHeart function: left ventricular ejection fraction ≧45%Patients must participate in this clinical trial voluntarily and sign an informed consent form.Exclusion Criteria:Acute promyeloid leukemia;AML with central nervous system (CNS) infiltration;Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML;Patients with a life expectancy <3 monthsPatients with uncontrolled active infection;HIV infection;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.Female who are pregnant, breast feeding or childbearing potential.Patients deemed unsuitable for enrollment by the investigator.
Source: ClinicalTrials.gov (NCT05662956). StuddyBuddy aggregates publicly available trial information.