(ARO-006) A Safety and Tolerability Trial of Crenolanib and Chemotherapy with Cytarabine and Anthracyclines in Patients with Newly Diagnosed Acute Myeloid Leukemia with FLT3 Activating Mutations
This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations. Acute myelogenous leukemia (AML) has a significant resistance to primary chemotherapy with a cure rate of only 30-40%. The prognosis varies according to cytogenetic status. Activating mutations of FLT3 including internal tandem duplication (ITD) mutations within the juxtamembrane domain and single base pair mutations within the tyrosine kinase domain (TKD) of the receptor are the most frequent mutations described in AML, with a prevalence of approximately 24-30%.[2, 3] Despite the presence of these mutations, there is no approved target specific therapy for AML patients who harbor them.