Trial Search Results
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Stanford Investigator(s):
Intervention(s):
- Drug: Asparaginase
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Drug: Etoposide
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
- Drug: Lestaurtinib
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Pegaspargase
- Other: Pharmacological Study
- Drug: Prednisone
- Drug: Therapeutic Hydrocortisone
- Drug: Vincristine Sulfate
Phase:
Phase 3
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
Exclusion Criteria:
- Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
- Patients with Down syndrome are NOT eligible
Ages Eligible for Study
N/A - 1 Year
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pediatric Hematology/Oncology
650-723-5535
Not Recruiting