Clinical Trial

A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.

Enrolling by Invitation Phase 3
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2018-04-16; most recent amendment 2025-03-13.
Trial Details
NCT Number NCT03507842
Lead Sponsor Asan Medical Center
Conditions Acute Myeloid Leukemia
Enrollment 380 participants
Start Date 2018-03-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-17