Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma

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.

DISEASE CHARACTERISTICS:

• Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL)

• Confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
• Results of the immunohistological analysis of expression of the CD20 antigen by lymphoma cells must be obtained
• Aggressive disease, including any of the following B-cell NHL

• Stage III follicular lymphoma
• Stage III follicular lymphoma and diffuse B-cell lymphoma
• Lymphoblastic precursor B-cell lymphoma
• Diffuse large B-cell lymphoma, including any of the following subtypes:

• Centroblastic
• Immunoblastic
• Plasmablastic
• Anaplastic large cell
• T-cell rich B-cell lymphoma
• Primary effusion lymphoma
• Intravasal B-cell lymphoma
• Primary mediastinal B-cell lymphoma
• Mantle zone lymphoma
• Burkitt or Burkitt-like lymphoma
• Aggressive marginal zone lymphoma (monocytoid)
• All risk group allowed

• Age adjusted IPI 0-3
• Previously untreated disease

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• No other serious concurrent diseases

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics