A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)
The overall goal of this study is to see whether making certain changes to the standard treatment can increase the percentage of patients who have their cancer go and stay away without causing unacceptable side effects. Participants in this study have been diagnosed with acute lymphoblastic leukemia (ALL) and are an infant younger than 366 days old. This study aims to evaluate a new drug called lestaurtinib. This drug is one of a new class of medicines that is able to block the action of an abnormal cancer-causing gene called “FLT3”. There is evidence that leukemia cells from MLL-R infants in the Intermediate and High Risk groups need FLT3 to “be on” to survive. The goal of this part of the study is to find out the effects, good and/or bad, of lestaurtinib given in combination with standard chemotherapy in treating Intermediate and High Risk infants with ALL.
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