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A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.
Sponsor: Asan Medical Center
Summary
This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin \[HDAC\] vs. cytarabine plus high-dose daunorubicin \[AD\]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).
Official title: A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
15 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2018-03-01
Completion Date
2028-12-31
Last Updated
2025-03-17
Healthy Volunteers
No
Conditions
Interventions
High dose Cytarabine
High dose Cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).
Cytarabine
cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)
Hign dose Daunorubicin
Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
Locations (1)
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea