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Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia

NCT01518556 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-03-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether idarubicin dose intensification is safe and effective as a remission induction therapy for acute myeloid leukemia.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Idarubicin

In the phase I study, idarubicin dose is increased step by step as follows: 12 mg/m2/day for 3 days IV in the 1st step; 15 mg/m2/day for 3 days IV in the 2nd step; 18 mg/m2/day for 3 days IV in the 3rd step. In the phase II study, idarubicin dose is the maximum tolerated dose that is determined from the phase I study or 18 mg/m2/day for 3 days .

Sponsors & Collaborators

  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Ewha Womans University

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Chonbuk National University Hospital

    collaborator OTHER

  • Pusan National University Hospital

    collaborator OTHER

  • Hanyang University Seoul Hospital

    collaborator OTHER

  • Soon Chun Hyang University

    collaborator OTHER

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Mark H Lee, M.D., Ph.D. · Konkuk University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • South Korea

Study Locations

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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 NCT01518556 on ClinicalTrials.gov