A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma
- Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP),
and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly
patients with intermediate or high-risk non-Hodgkin's lymphoma.
- Compare the complete remission rate, overall survival, and disease-free survival of
patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, WHO classification, and International Prognostic Index score. Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day
1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14.
Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or
- Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and
G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on
day 1 of courses 3-6 for a total of 6 doses.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Pieter Sonneveld, MD, PhD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government