Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control AML and MDS. The safety of these study drug combinations will also be studied.
Treatment Location: N/A
Phase I Primary: Determine the MTD of clofarabine to be used in portion II of the study. Phase II Primary: Compare the response rates of two different regimens CIA versus FLAI Secondary: Evaluate the durability of response, the overall and event-free survival rates, and the safety profile of 2 different regimens.
IRB Review and Approval Date: 02/02/2011
Recruitment Status: Closed
Projected Accrual: N/A