Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Acute Undifferentiated Leukemia; Childhood T Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Asparaginase; Biospecimen Collection; Bone Marrow Biopsy; Cyclophosphamide; Cytarabine; Daunorubicin Hydrochloride; Dexamethasone; Echocardiography; Etoposide; Filgrastim; Laboratory Biomarker Analysis; Lestaurtinib; Leucovorin Calcium; Mercaptopurine; Methotrexate; Methylprednisolone; Multigated Acquisition Scan; Pegaspargase; Pharmacological Study; Prednisone; Therapeutic Hydrocortisone; Vincristine Sulfate
Intervention description: Given IV, IM, or PO; Undergo blood sample collection; Undergo bone marrow biopsy; Given IV; Given IV or IT; Given IV; Given IV or PO; Undergo ECHO; Given IV; Given IV or SC; Correlative studies; Given PO; Given IV; Given PO; Given IV, IT, or PO; Given IV; Undergo MUGA; Given IM; Correlative studies; Given PO; Given IT; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cortisone; Cyclophosphamide; Methotrexate; Etoposide; Vincristine; Etoposide phosphate; Daunorubicin; Asparaginase; Mercaptopurine; Podophyllotoxin; Pegaspargase; Lenograstim; Prednisolone hemisuccinate; Prednisolone phosphate; BB 1101; Calcium; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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