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Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)

NCT01145846 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2010-06-17

No results posted yet for this study

Summary

The purpose of this non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin \[AI\] versus cytarabine plus high-dose daunorubicin \[AD\]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Cytarabine plus Daunorubicin [Arm II (AD regimen)]

Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)

Sponsors & Collaborators

  • Cooperative Study Group A for Hematology

    lead NETWORK

Principal Investigators

  • Je Hwan Lee, Professor · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-04-30
Completion
2014-04-30

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 NCT01145846 on ClinicalTrials.gov