Trial Information

Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma

OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with
recurrent or refractory indolent non-Hodgkin's lymphoma. II. Determine the objective tumor
response rate and duration of response at 2 months after initiation of therapy, and the
percentage of patients with progressive disease. III. Determine the maximum response,
duration of response, and progression free interval for patients who have not progressed
after 4 weeks of therapy. IV. Determine the failure-free and overall survival of these
patients on this regimen. V. Compare the response rate and survival rates to results for
similar patients (historical and concurrent) who have received 4 weeks of rituximab without
dexamethasone, and patients who did not receive maintenance rituximab.

OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22
for one course. Two months after initiating treatment, patients are evaluated for disease
progression. Patients with stable or responding disease may receive monthly dexamethasone
and rituximab therapy for up to 10 additional months. Patients are followed every 3 months
for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.