Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)|
- Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery [ Time Frame: 8 weeks after Induction therapy (induction cycle 4-6 weeks) ] [ Designated as safety issue: No ]Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.
- Median Event-Free Survival (EFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death.
|Study Start Date:||January 2010|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Clofarabine, Cytarabine + Idarubicin
Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
Induction Cycle: 20 mg/m^2 IV over approximately 1 hour daily for 5 days (days 1-5)
Other Names:Drug: Idarubicin
Induction Cycle: 10 mg/m^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours
Other Name: IdamycinDrug: Cytarabine
Induction Cycle: 1 g/m^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025154
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Stefan Faderl, MD||UT MD Anderson Cancer Center|