Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT03507842
PHASE3

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

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

Cytarabine

cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)

DRUG

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