Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life
- 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.
- 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
- 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
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, and then annually thereafter.
Allocation: Randomized, Primary Purpose: Treatment
Complete remission rate at 6 months
Pierre Soubeyran, MD, PhD