A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896,NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD.
The purpose of this study is to confirm that bortezomib is tolerated when given with standard chemotherapy treatment. In addition, this study wants to see if bortezomib helps improve treatment success for children, adolescents and young adults with AML. Bortezomib is an experimental drug that has been shown to reduce the numbers of leukemia cells, as well as increase the effect of chemotherapy. Bortezomib has been studied in adults with AML in combination with standard chemotherapy drugs. It has also been studied in small groups of pediatric patients. These studies have determined what dose of bortezomib can be tolerated when given with other chemotherapy drugs.
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