Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT00557193


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)


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

   - 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


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

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