Trial Information

Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma

OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab
(IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV
indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of
response associated with this first line treatment in these patients. III. Determine the
failure-free and overall survival for these patients. IV. Compare the response rate and
survival rates for patients with indolent lymphoma who were treated with this treatment as
the first systemic therapy for their disease with response rates and survival observed for
similar patients treated in published trials. V. Determine the quality of life associated
with this treatment in this patient population.

OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and
rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week
course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2
months beyond maximum response. Patients are treated for at least 6 months but no more than
18 months in the absence of disease progression. Patients are followed every 3 months for 2
years, then every 6 months for the next 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.