©2024 Stanford Medicine
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Not Recruiting
Trial ID: NCT00557193
Purpose
This phase III trial studies combination chemotherapy with or without lestaurtinib with to
see how well they work in treating younger patients with newly diagnosed acute lymphoblastic
leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. It is not yet known whether combination chemotherapy is more
effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
Official Title
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; NSC#617807)
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients must be enrolled on a Children's Oncology Group (COG) ALL Classification
Study (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 of steroids and intrathecal
chemotherapy; no other systemic chemotherapy may have been administered; patients
receiving prior steroid therapy are eligible for study; any amount of steroid
pretreatment will not affect initial induction assignment as long as the patient meets
all other eligibility criteria; IT chemotherapy per protocol is allowed for patient
convenience at the time of the diagnostic bone marrow or venous line placement to
avoid second lumbar puncture; (note: the central nervous system [CNS] status must be
determined based on a sample obtained prior to administration of any systemic or
intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must
begin within 72 hours of this IT therapy
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
- Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
- Patients with Down syndrome are NOT eligible
Intervention(s):
drug: vincristine sulfate
drug: asparaginase
drug: cyclophosphamide
drug: cytarabine
drug: daunorubicin hydrochloride
drug: dexamethasone
drug: etoposide
drug: lestaurtinib
drug: leucovorin calcium
drug: mercaptopurine
drug: methotrexate
drug: methylprednisolone
drug: pegaspargase
drug: prednisone
drug: therapeutic hydrocortisone
biological: filgrastim
other: laboratory biomarker analysis
other: pharmacological study
procedure: Biospecimen Collection
procedure: Bone Marrow Biopsy
procedure: Echocardiography
procedure: Multigated Acquisition Scan
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pediatric Hematology/Oncology
650-723-5535