Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: 3-Dimensional Conformal Radiation Therapy; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Leucovorin Calcium; Mercaptopurine; Methotrexate; Pegaspargase; Thioguanine; Vincristine Sulfate
Intervention description: Some patients undergo cranial radiotherapy; Given IV; Given IV or SC; Given IV or PO; Given IV or IT; Given PO; Given PO; Given IM or IT; Given IM; 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: 5377.0
Sex: All
Minimum age: 1 Year
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying different combination chemotherapy regimens and
      comparing how well they work in treating patients with newly diagnosed acute lymphoblastic
      leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331

          -  Initial white blood cells (WBC) < 50,000/ul

          -  Newly diagnosed B-precursor acute lymphoblastic leukemia

               -  Standard-risk (SR) disease meeting 1 of the following criteria:

               -  SR-average by age and WBC

               -  No unfavorable features

               -  Rapid early responder (RER) by day 15

               -  CNS 1 or 2

               -  Minimal residual disease (MRD) negative on day 29

               -  Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed

               -  SR-low by age and WBC

               -  No unfavorable features

               -  RER by day 15

               -  MRD negative on day 29

               -  CNS1

               -  Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation

               -  SR-high

               -  Unfavorable features meeting ≥ 1 of the following criteria:

                    -  MLL rearrangements and RER

                    -  Steroid pretreatment

                    -  CNS3

                    -  Slow early responder by morphology or MRD

          -  Patients with Down syndrome are allowed

          -  Patients with overt testicular disease are not eligible for this study, but may be
             eligible for AALL0232

          -  Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids
             and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior
             to registration for patient convenience; this is usually done at the time of the
             diagnostic bone marrow or venous line placement to avoid a 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

          -  Patients receiving prior steroid therapy may be eligible for AALL0331 study

          -  Patients with a contraindication to additional asparaginase therapy, following
             Induction, are not eligible for the Standard Risk-Low study, and should be removed
             from protocol therapy at the end of Induction

          -  Patients who are assigned to the standard risk-average group following Induction and
             who meet the HRQOL

          -  Age at diagnosis >= 2 years (note that this is a more restrictive age range than for
             the therapeutic component of the study)

          -  At least one parent with reading comprehension of English or Spanish languages for
             which validated surveys exist

          -  Diagnosis at one of the institutions participating in this limited institution
             correlative study

          -  A parent or legal guardian must sign a written informed consent/parental permission
             for all patients

          -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
             (NCI) requirements for human studies must be met