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Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)

NCT00422591 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2018-08-23

Study results available
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Summary

The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.

Objectives:

To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.

Conditions

Interventions

DRUG

Cytarabine

1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).

DRUG

Idarubicin

12 mg/m2 IV over 1 hour daily x 3 (days 1-3)

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Farhad Ravandi-Kashani, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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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 NCT00422591 on ClinicalTrials.gov