Trial Information

Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life

OBJECTIVES:

- Determine the complete remission (CR) rate and duration of CR in frail elderly patients
with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with
cyclophosphamide, vincristine, and prednisone.

- Determine the time to progression and overall survival of patients treated with this
regimen.

- Determine the severe toxicity rate of this regimen in these patients.

- Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days
1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity.

Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase
(LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less
than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional
course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days
a week for 3.5-4 weeks.

Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance
status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3
additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once
daily 5 days a week for 3.5-4 weeks.

Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of
chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for
2.5-3 weeks.

Quality of life is assessed at baseline, after the third chemotherapy course, at the end of
chemotherapy, every 6 months for 3 years, and then annually thereafter.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 29-56 patients will be accrued for this study within 12-18
months.