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

NCT03507842 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-03-17

No results posted yet for this study

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).

Conditions

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).

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Je-Hwan Lee, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507842 on ClinicalTrials.gov