Title (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)
Principal Investigator Martin Brecher, MD
Study Number 196511
Summary 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.
- Patients must be enrolled on a COG ALL Classification study (AALL03B1 or AALL08B1) prior to enrollment on AALL0631.
- Patients must be < 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be > 36 weeks gestational age at the time of diagnosis.
- Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL). Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid.
- Patients must be previously untreated, with the exception that steroid treatment in the 48 hours prior to study entry will be allowed, provided that a physical examination and CBC with differential were performed immediately prior to beginning steroids, patients on chronic steroid treatment for another disease are NOT eligible for this study
- Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible.
- Patients with Down Syndrome are NOT eligible.