At a glance
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NCT03021330Phase 3ActiveMonitorUpdated 13mo ago · Completion was 1mo agoEfficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
In Brief
A Phase 3 clinical trial evaluating Daunomycin and Cytarabine (DA Regimen) and Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) for AML. Active but no longer recruiting, targeting 1,100 participants across 1 site.
Signals
Detailed Summary
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Study Details
Timeline
Interventions
Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.
Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.