Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
|ClinicalTrials.gov Identifier: NCT00422591|
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : January 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Acute Myeloid Leukemia AML||Drug: Cytarabine Drug: Idarubicin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)|
|Study Start Date :||December 2006|
|Primary Completion Date :||January 2017|
|Study Completion Date :||January 2017|
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®
- Complete Response (CR) Rate [ Time Frame: October 2010 ]
- Event-Free Survival (EFS) [ Time Frame: October 2010 ]
- Overall Survival (OS) [ Time Frame: October 2010 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|