This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.
Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.
Azacitidine is used in VA regimen
Blood Diseases Hospital
Tianjin, China
RECRUITINGOverall Survival (OS)
Time from randomization to death from any cause.
Time frame: up to 1 years after completion of enrollment
Composite Complete Remission Rate (CR/CRh/CRi)
Proportion of patients achieving CR, CRh, or CRi after induction.
Time frame: Six weeks after induction therapy
MRD Negativity Rate
Proportion of patients achieving MRD negativity after induction and overall treatment.
Time frame: up to 1 years after completion of enrollment
Relapse-Free Survival (RFS)
Time from achieving CR/CRh/CRi to relapse or death.
Time frame: up to 1 years after completion of enrollment
Event-Free Survival (EFS)
Time from randomization to treatment failure, relapse, or death.
Time frame: up to 1 years after completion of enrollment
30-Day and 60-Day Mortality Rates
Proportion of patients who die within 30 and 60 days of starting treatment.
Time frame: within 30 and 60 days of starting treatment.
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Venetoclax is used in VA regimen