Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and
      vincristine, 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. Monoclonal antibodies, such
      as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them
      or carry cancer-killing substances to them. Others interfere with the ability of cancer cells
      to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is
      more effective when given with or without rituximab in treating non-Hodgkin lymphoma.

      PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and
      combination chemotherapy together with or without rituximab and to see how well it works in
      treating older patients with aggressive B-cell non-Hodgkin lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin
           hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older
           patients with aggressive B-cell non-Hodgkin lymphoma.

        -  Determine adherence to therapy regimens in these patients.

        -  Determine antitumor effectivity of immunochemotherapy.

      OUTLINE: This is a multicenter study.

      All patients receive prephase treatment comprising vincristine on day -6 and prednisone on
      days -6 to 0. Patients are then randomized to 1 of 2 treatment arms.

        -  Arm I (without rituximab): Patients receive pegfilgrastim subcutaneously (SC) on day 2
           or 4 and CHOP comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and
           vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2
           weeks for up to 6-8 courses in the absence of disease progression or unacceptable
           toxicity.

        -  Arm II (with rituximab): Patients receive pegfilgrastim and CHOP for up to 6-8 courses
           as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on
           day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.

      Patients with bulky disease or extranodal disease also undergo radiotherapy.
    

Intervention name(s): pegfilgrastim; rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug
Intervention description(s): Given subcutaneously; Given IV; Given IV; Given IV; Given orally; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: stage III grade 3 follicular lymphoma; stage I adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; anaplastic large cell lymphoma; stage III adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; stage III mantle cell lymphoma; stage I mantle cell lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage I adult Burkitt lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma; stage I marginal zone lymphoma; contiguous stage II marginal zone lymphoma; noncontiguous stage II marginal zone lymphoma