Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
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.
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.
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)|
- Complete Response (CR) Rate [ Time Frame: October 2010 ] [ Designated as safety issue: No ]
- Event-Free Survival (EFS) [ Time Frame: October 2010 ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: October 2010 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Idarubicin + Cytarabine
Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
Other Names:Drug: Idarubicin
12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
Other Name: Idamycin®
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00422591
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|