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Brief Title: Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Official Title: A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT00193479
Brief Summary: The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.
Detailed Description: Upon determination of eligibility, patients will receive: * Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Cancer Specialists, Fort Myers, Florida, United States
Tennessee Oncology, Nashville, Tennessee, United States
Name: John D. Hainsworth, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR