Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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. Drugs used in chemotherapy, such
      as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Colony-stimulating factors, such as
      pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral
      blood and may help the immune system recover from the side effects of chemotherapy. Giving
      rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating
      leukemia or non-Hodgkin's lymphoma.

      PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide
      together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade
      non-Hodgkin's lymphoma, or mantle cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in
           patients with B-cell leukemia or low-grade or mantle cell lymphoma.

        -  Determine the molecular response rate in patients treated with this regimen.

      OUTLINE: This is an open-label study.

      Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52,
      cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or
      20 in the absence of unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
    

Intervention name(s): Pegfilgrastim; Rituximab; Cyclophosphamide
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 6 mg SQ 24-48 hours after last dose of cyclophosphamide.; 375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.; 50 mg/kg/day on Days 15, 16, 17, and 18.
Other intervention name(s): Neulasta; Rituxan; Cytoxan; Cy; CTX
Intervention MeSH terms: Cyclophosphamide; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; small lymphocytic lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; B-cell chronic lymphocytic leukemia; splenic marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage I mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; Waldenstrom macroglobulinemia; prolymphocytic leukemia; stage I marginal zone lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage III marginal zone lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; refractory chronic lymphocytic leukemia; stage IV marginal zone lymphoma