Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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. Monoclonal antibodies, such as
      rituximab, can block cancer growth in different ways. Some block the ability of cancer cells
      to grow and spread. Others find cancer cells and help kill them or carry cancer-killing
      substances to them. Giving combination chemotherapy together with rituximab may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or
      leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the overall response rate, 1-year event-free survival, and overall survival of
           adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia
           treated with dose-intensified induction therapy comprising cyclophosphamide,
           vincristine, prednisone, and rituximab followed by consolidation therapy comprising
           rituximab and high-dose cyclophosphamide.

        -  Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability
           of this regimen in these patients.

      Secondary

        -  Determine the 3-year event-free survival and overall survival of patients treated with
           this regimen.

        -  Determine the general patterns of CNS and systemic relapse in patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

        -  Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and
           vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and rituximab
           IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV rescue on
           day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on
           day 3 and continuing until blood counts recover. Treatment repeats approximately every
           14 days for 2 courses.

        -  CNS therapy: Patients receive cytarabine intrathecally (IT) with or without
           hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with
           evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly
           during any induction therapy treatment delay. Patients who demonstrate CSF clearance
           receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses
           during consolidation therapy. Patients with disease progression during induction therapy
           or persistent CNS involvement by lymphoma are removed from the study. All other patients
           proceed to consolidation therapy.

        -  Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose
           cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily
           beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on
           day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of
           disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 3 years.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
    

Intervention name(s): Filgrastim; Rituximab; Cyclophosphamide; Cytarabine; Methotrexate; Prednisone; Hydrocortisone; Vincristine; Leucovorin
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.; 375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy.; 1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.; 100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.; 3 g/m^2 on Day 8 of each cycle of R-CVP.; 100 mg on Days 1-5 of each cycle of R-CVP.; 50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.; 1.4 mg/m^2 on Day 1 of each cycle of R-CVP.; 25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.
Other intervention name(s): Neupogen; G-CSF; Rituxan; Cytoxan; Cy; CTX; HiCy; Ara-C; MTX; Deltasone; Oncovin; Folinic acid
Intervention MeSH terms: Leucovorin; Cytarabine; Prednisone; Hydrocortisone; Cyclophosphamide; Rituximab; Methotrexate; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated adult acute lymphoblastic leukemia; L3 adult acute lymphoblastic leukemia; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma