Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Condition: Acute Lymphoblastic Leukemia; Adult B Lymphoblastic Lymphoma; Ann Arbor Stage I B Lymphoblastic Lymphoma; Ann Arbor Stage II B Lymphoblastic Lymphoma; Childhood B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Childhood B Lymphoblastic Lymphoma; Down Syndrome; Hypodiploid B Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin; Down Syndrome; Philadelphia Chromosome
Intervention: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Leucovorin Calcium; Mercaptopurine; Methotrexate; Pegaspargase; Quality-of-Life Assessment; Questionnaire Administration; Thioguanine; Vincristine Sulfate
Intervention description: Given IV; Given IT, IV, or SC; Given orally (PO) or IV; Given IV; Correlative studies; Given PO; Given PO; Given IT, PO, or IV; Given IV; Ancillary studies; Ancillary studies; Given PO; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Asparaginase; Mercaptopurine; Pegaspargase; Thioguanine; BB 1101; Calcium; 2-Aminopurine; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9350.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This partially randomized phase III trial studies the side effects of different combinations
      of risk-adapted chemotherapy regimens and how well they work in treating younger patients
      with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic
      lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in
      chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Giving more than
      one drug (combination chemotherapy), giving the drugs in different doses, and giving the
      drugs in different combinations may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the
             classification of newly diagnosed ALL patients) prior to treatment and enrollment on
             AALL0932

               -  Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto
                  AALL0932

          -  B-ALL patients must have an initial white blood cell count < 50,000/uL

          -  Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL
             or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible

               -  Note: for B-LLy patients with tissue available for flow cytometry, the criterion
                  for diagnosis should be analogous to B-ALL; for tissue processed by other means
                  (i.e. paraffin blocks), the methodology and criteria for immunophenotypic
                  analysis to establish the diagnosis of B-LLy defined by the submitting
                  institution will be accepted

          -  All patients and/or their parents or legal guardians must sign a written informed
             consent

          -  All institutional, Food and Drug Administration (FDA), and NCI requirements for human
             studies must be met

        Exclusion Criteria:

          -  With the exception of steroid pretreatment (defined below) or the administration of
             intrathecal cytarabine, patients must not have received any prior cytotoxic
             chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer
             diagnosed prior to initiation of protocol therapy on AALL0932

               -  Patients receiving prior steroid therapy may be eligible for AALL0932

          -  Patients with central nervous system 3 (CNS3) leukemia

               -  CNS status must be known prior to enrollment; (Note: the CNS status must be
                  determined based on a sample obtained prior to administration of any systemic or
                  intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with
                  CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is
                  recommended that intrathecal cytarabine be administered at the time of the
                  diagnostic lumbar puncture; this is usually done at the time of the diagnostic
                  bone marrow or venous line placement to avoid a second lumbar puncture; this is
                  allowed prior to registration; systemic chemotherapy must begin within 72 hours
                  of the first dose of intrathecal therapy

          -  B-ALL patients with testicular leukemia are not eligible for AALL0932

          -  For B-LLy patients the following additional exclusion criteria apply:

               -  T-lymphoblastic lymphoma

               -  Morphologically unclassifiable lymphoma

               -  Absence of both B-cell and T-cell phenotype markers in a case submitted as
                  lymphoblastic lymphoma

               -  CNS3-positive disease or testicular involvement

               -  M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow

               -  Female patients who are pregnant are ineligible

               -  Lactating females are not eligible unless they have agreed not to breastfeed
                  their infants

               -  Female patients of childbearing potential are not eligible unless a negative
                  pregnancy test result has been obtained

               -  Sexually active patients of reproductive potential are not eligible unless they
                  have agreed to use an effective contraceptive method for the duration of their
                  study participation