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

NCT03507842 | Enrolling By Invitation Phase 3

• 1 other identifier: AMC_HDAC vs AD in AML
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia

Keywords

HDAC vs AD

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of relapse

  defined for all patients achieving CR; measured from the date of CR achievement until the date of relapse; patients not known to have relapsed are censored on the date they were last examined; patients who died without relapse are counted as a competing cause of failure

  3 years

Secondary Outcomes (2)

• Event-free survival

  3years

• Overall survival

  3years

Study Arms (2)

High-dose cytarabine

EXPERIMENTAL

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: High dose Cytarabine

high-dose daunorubicin

EXPERIMENTAL

cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus high-dose daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).

Drug: Cytarabine; Drug: Hign dose Daunorubicin

Interventions

High dose Cytarabine DRUG

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).

Also known as: HDAC

High-dose cytarabine

Cytarabine DRUG

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

Also known as: AD

high-dose daunorubicin

Hign dose Daunorubicin DRUG

Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).

Also known as: AD

high-dose daunorubicin

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Previously-untreated AML (≥ 20% blasts in bone marrow and/or peripheral blood)
• Age of 15 years or older, 60 years or younger
• Adequate performance status (Karnofsky score of 50 or more)
• Adequate hepatic and renal function (AST, ALT, and bilirubin \< 2.5 x upper normal limit and creatinine \< 2.0 mg/dL \& creatinine clearance ≥ 50 mL/min). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
• Adequate cardiac function (left ventricular ejection fraction ≥45% on heart scan or echocardiogram)
• Signed informed consent

You may not qualify if:

• Patients with history of chemotherapy for leukemia or cytarabine and anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
• Patients with acute promyelocytic leukemia
• Patients with blast crisis of chronic myeloid leukemia
• Patients with central nervous system (CNS) leukemia or granulocytic sarcoma without bone marrow involvement
• Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.)
• Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
• Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Je-Hwan Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 25, 2018
• Study Start: March 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)