COG-AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)

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COG-AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)

We want to find out if adding lestaurtinib to standard therapy for Intermediate and High Risk infants with ALL will result in better treatment outcomes than standard chemotherapy alone. Since lestaurtinib only targets leukemia cells, it is hoped that the side effects of lestaurtinib will be less than for standard chemotherapy drugs. Although lestaurtinib is investigational and has not been approved by the FDA, it has been shown to be well-tolerated in children and adults. The side effects of lestaurtinib in infants are not known because the drug hasn?t been evaluated in infants yet.

The goal of Part 1 of the study is to find the dose of lestaurtinib that is safe and that can turn off the FLT3 gene when given to Intermediate and High Risk infants with ALL.

During Part 1 of the study, lestaurtinib will be given to Intermediate and High Risk patients only at a limited number of cancer treatment centers. The Cancer Institute of New Jersey is NOT one of these centers. Therefore subjects will receive the combination chemotherapy treatment without lestaurtinib.

Part 2 of this study will only be undertaken if Part 1 of the study successfully finds a dose of lestaurtinib that is safe and can turn off the FLT3 gene. In Part 2 of the study, the researchers will try to find out how helpful lestaurtinib is in getting rid of cancer in infants with Intermediate and High Risk. Subjects participating in Part 1 of the study will not participate in Part 2 of the study.

The goal of Part 2 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.

Protocol Number110811
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesLeukemia, not otherwise specified
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedPREDNISONE
L-ASPARAGINASE
CYTARABINE
Intrathecal Cytarebine (IT AraC)
DEXAMETHASONE
Participating InstitutionsRobert Wood Johnson University Hospital in New Brunswick
Rutgers Cancer Institute of New Jersey
Robert Wood Johnson Medical School

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.