Trial Information

Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma

OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV
high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor
response rate and duration of response for these regimens in these patients. III. Determine
the failure free survival and overall survival for these patients on these regimens. IV.
Compare the response rate and survival rate of these patients on these regimens to similar
patients treated in published studies. V. Compare the toxicities of these regimens in these
patients. VI. Determine the quality of life of these patients on these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms:
Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive
interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients
are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for
up to 10 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for
this study.