(COG AALL0631) 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, Lestraurtinib; IND #76431; NSC #617807)

Infants with acute lymphoblastic leukemia (ALL), and in particular those with mixed lineage leukemia (MLL) gene rearrangement, have experienced poor outcomes. This study will be done in two phases: a safety/activity phase, which will determine the dose of lestaurtinib that, in combination with P9407-based chemotherapy is safe, tolerable and biologically active in infants with MLL-R ALL; and an efficacy phase in which infants with MLL-R ALL will be randomized to the modified chemotherapy regimen with or without the incorporation of lestaurtinib. Infants with MLL-G ALL will be non-randomly assigned to receive a less intensive chemotherapy regimen without lestaurtinib.

Study Number: 

NCG 196511

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.