Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial

OBJECTIVES: Primary * To assess the therapeutic efficacy of rituximab, cyclophosphamide, vincristine sulfate, and prednisone with vs without liposome-encapsulated doxorubicin citrate, in terms of complete remission rate at 6 months, in vulnerable or frail elderly patients with stage II, III, or IV diffuse large B-cell non-Hodgkin lymphoma. * To assess the safety of these regimens in these patients. Secondary * To evaluate the progression-free survival, event-free survival, and overall survival rates at 6 and 24 months in patients treated with these regimens. * To evaluate the overall response rate at 6 and 24 months in patients treated with these regimens. * To evaluate the duration of complete remission in patients treated with these regimens. * To evaluate the acute side effects (according to the International CTC scale) of these regimens in these patients. * To evaluate the geriatric condition and quality of life of patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I (R-COP regimen): Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. * Arm II (R-COPY regimen): Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. After 3 courses of R-COP or R-COPY, patients undergo evaluation. Patients with disease progression or a response of \< 25% are removed from the study. Patients with a response of ≥ 25% receive 3 more courses of R-COP or R-COPY, followed by rituximab IV alone on day 1 of courses 7 and 8 in the absence of disease progression or unacceptable toxicity. After the completion of chemotherapy, some patients may undergo radiotherapy. Patients complete quality of life and geriatric assessment questionnaires at baseline and periodically during study treatment. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years.