Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Intervention: Pegfilgrastim; Rituximab; Cyclophosphamide
Intervention description: 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.
Intervention MeSH terms: Cyclophosphamide; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  One of the following B-cell leukemias or lymphomas, as defined by World Health
             Organization criteria:

               -  Chronic lymphocytic leukemia/small lymphocytic lymphoma

               -  B-cell prolymphocytic leukemia

               -  Lymphoplasmacytic leukemia

               -  Marginal zone lymphoma (splenic, extranodal, or nodal)

               -  Follicular lymphoma (grade 1 or 2)

               -  Mantle cell lymphoma

          -  No more than minimal (approximately 10%) morphologically identifiable cancer cells on
             bone marrow biopsy

               -  When cancer cells are morphologically difficult to distinguish from normal cells,
                  flow cytometry must show no more than 10% identifiable cancer cells

          -  Must have received ≤ 12 months of prior cytotoxic therapy, achieving at least a
             partial response NOTE: A new classification scheme for adult non-Hodgkin's lymphoma
             has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will
             replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
             However, this protocol uses the former terminology.

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC ≥ 3,000/mm^3

          -  Hemoglobin ≥ 10.0 g/dL

          -  Platelet count ≥ 75,000/mm^3

          -  Serum creatinine ≤ 2.0 mg/dL

          -  Total bilirubin ≤ 2 mg/dL unless secondary to tumor

          -  AST or ALT < 2 times upper limit of normal

          -  Normal (≥ 45%) left ventricular cardiac ejection fraction (determined by
             echocardiogram or MUGA scan)

          -  DLCO > 50% predicted

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known sensitivity to E. coli-derived products (e.g. filgrastim [G-CSF], insulin,
             asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatment
             study drugs

          -  No active infections requiring oral or intravenous antibiotics

          -  No other second malignancy other than basal cell or squamous cell carcinoma of the
             skin or in situ carcinoma of the cervix unless the malignancy was localized and
             treated or resected with > 90% probability of cure

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior anti-CD20 therapy allowed provided patient achieved a partial or complete
             response

          -  No concurrent steroids during rituximab administration