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Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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.
Key Details
Gender
All
Age Range
14 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2017-02-08
Completion Date
2027-10-15
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Daunomycin and Cytarabine (DA Regimen)
Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.
Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
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.
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China