drugset / Trial / NCT03507842

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

NCT03507842

Phase 3 Enrolling by invitation 380 enrolled Asan Medical Center
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2018-03-01
Primary completion
2028-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 200 mg/m2 Intravenous
Subject Cytarabine Small molecule 3 g Intravenous
Subject Daunorubicin Small molecule 45 mg/m2 Intravenous
Subject Daunorubicin Small molecule 90 mg/m2 Intravenous