Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
Condition: B-cell Childhood Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: vincristine sulfate; prednisone; doxorubicin hydrochloride; pegaspargase; cytarabine; methotrexate; dexamethasone; etoposide; cyclophosphamide; leucovorin calcium; filgrastim; asparaginase; mercaptopurine
Intervention description: Given IV; Given PO; Given IV; Given IM; Given IT or IV; Given IT or IV; Given PO; Given IV; Given IV; Given IV or PO; Given IV or SC; Given IM; Given PO
Intervention MeSH terms: Leucovorin; Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Etoposide phosphate; Asparaginase; Mercaptopurine; Pegaspargase; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 1 Year
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying low-dose vincristine to see how well it works
      compared with high-dose vincristine when given together with different combination
      chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell 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) and giving the drugs in different ways and different
      doses may kill more cancer cells..
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute lymphoblastic leukemia (ALL)

               -  Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)

                    -  Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc
                       translocation are not eligible (considered Burkitt's or mature B-cell
                       leukemia)

          -  Intermediate-risk relapsed disease, meeting 1 of the following criteria:

               -  Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow
                  after previous remission from ALL)

               -  Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36
                  months after initial diagnosis

               -  Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after
                  initial diagnosis

          -  The following subtypes are not allowed:

               -  T-lineage ALL

               -  Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of
                  c-myc translocation)

               -  Philadelphia-chromosome positive disease

          -  No Down syndrome (trisomy 21)

          -  Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by
             radionuclide angiogram

          -  Bilirubin < 3.0 mg/dL

          -  Not pregnant

          -  Fertile patients must use effective contraception

          -  No history of peripheral neuropathy >= grade 3 within the past month

          -  No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine within
             the past month

          -  At least 5 days since prior intrathecal chemotherapy

          -  No prior hematopoietic stem cell or marrow transplantation

          -  No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)

          -  No concurrent stem cell transplant

          -  No concurrent alternative therapy

          -  No concurrent itraconazole in patients receiving vincristine

          -  No concurrent intensity-modulated radiotherapy