Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Cyclophosphamide; Cytarabine; Daunorubicin Hydrochloride; Dexamethasone; Doxorubicin Hydrochloride; Leucovorin Calcium; Mercaptopurine; Methotrexate; Pegaspargase; Prednisone; Radiation Therapy; Thioguanine; Vincristine Sulfate
Intervention description: Given IV; Given IT, SC, or IV; Given IV; Given PO or IV; Given IV; Given IV; Given PO; Given IT or IV; Given IM; Given PO or IV; Undergo radiation therapy; Given PO; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisone; Cortisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Pegaspargase; Thioguanine; BB 1101; Calcium; 2-Aminopurine; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3154.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying dexamethasone to see how well it works compared
      to prednisone during induction therapy. This trial is also studying methotrexate and
      leucovorin calcium to see how well they work compared to methotrexate alone during
      maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia
      (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and
      leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop
      growing or die. Giving more than one drug may kill more cancer cells. It is not yet known
      which combination chemotherapy regimen is more effective in treating acute lymphoblastic
      leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be eligible for and enrolled on classification study COG-AALL03B1

          -  Newly diagnosed B-precursor acute lymphoblastic leukemia

               -  WBC > 50,000/mm^3 for patients age 1 to 9

               -  Any WBC for patients age 10 to 30 OR patients who have received prior steroid
                  therapy OR patients with testicular disease

          -  Whit blood cell (WBC) criteria:

               -  Age 1 - 9 years: WBC >= 50,000/uL

               -  Age 10 - 30 years: any WBC

               -  Prior steroid therapy: any WBC

               -  Testicular disease: any WBC

          -  Patients shall have had no other prior cytotoxic chemotherapy with the exception of
             steroids and intrathecal cytarabine

          -  Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for
             study; the dose and duration of previous steroid therapy should be carefully
             documented

          -  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 Down syndrome are ineligible to enroll onto this study