Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
Condition: Childhood Burkitt Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Stage I Childhood Large Cell Lymphoma; Stage I Childhood Small Noncleaved Cell Lymphoma; Stage II Childhood Large Cell Lymphoma; Stage II Childhood Small Noncleaved Cell Lymphoma; Stage III Childhood Large Cell Lymphoma; Stage III Childhood Small Noncleaved Cell Lymphoma; Stage IV Childhood Large Cell Lymphoma; Stage IV Childhood Small Noncleaved Cell Lymphoma; Untreated Childhood Acute Lymphoblastic Leukemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: doxorubicin hydrochloride; cyclophosphamide; methotrexate; rasburicase; leucovorin calcium; prednisone; methylprednisolone; filgrastim; rituximab; cytarabine; etoposide; vincristine sulfate; hydrocortisone sodium succinate; laboratory biomarker analysis
Intervention description: Given IV, IT, or orally; Given IV; Given IV or IT; Given IV; Given IV or orally; Given IV or orally; Given IV or orally; Given subcutaneously; Given IV; Given IT; Given IV; Given IV; Given IT; Correlative studies
Intervention MeSH terms: Leucovorin; Cytarabine; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Etoposide phosphate; Rasburicase; Prednisolone hemisuccinate; Prednisolone phosphate; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 1 Year
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of combining rituximab and rasburicase with
      combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell
      leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and
      either kill them or deliver cancer-killing substances to them without harming normal cells.
      Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they
      stop growing or die. Combining more than one drug with rituximab may kill more cancer cells.
      Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL
             classification of 1 of the following subtypes:

               -  Diffuse large cell lymphoma

               -  Burkitt's lymphoma

               -  High-grade B-cell lymphoma (Burkitt-like)

          -  No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas

          -  One of the following FAB prognostic groups:

               -  Group B (intermediate risk)

               -  Group C (high risk)

                    -  Bone marrow involvement with at least 25% blasts and/or CNS involvement
                       meeting 1 or more of the following criteria:

                         -  Any L3 blasts in cerebrospinal fluid

                         -  Cranial nerve palsy (if not explained by extracranial tumor)

                         -  Clinical spinal cord compression

                         -  Isolated intracerebral mass

                         -  Parameningeal extension (cranial and/or spinal)

          -  Hepatitis B status known

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after study
             participation

          -  No known history of congenital immune deficiency and/or laboratory evidence of
             acquired immune deficiency

          -  No known G6PD deficiency (if receiving rasburicase)

          -  No prior malignancies treated with systemic chemotherapy with alkylator or
             anthracycline therapy

          -  No prior chemotherapy

          -  At least 1 week since prior steroids except emergency steroids initiated within 72
             hours of study entry

          -  No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study
             entry

          -  No concurrent radiotherapy

          -  No prior solid organ transplantation