drugset / Trial / NCT03021330

Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

NCT03021330

Phase 3 Active not recruiting 1100 enrolled Institute of Hematology & Blood Diseases Hospital, China
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-02-08
Primary completion
2026-05-15
Completion
2027-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 100 mg/m2
Comparator Cytarabine Small molecule 1 g
Comparator Daunorubicin Small molecule 60 mg/m2