Trial Information

A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

OBJECTIVES: I. Determine the 2 year failure free survival rate of patients with newly
diagnosed follicular lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) followed by iodine I 131 monoclonal antibody anti-B1. II. Determine the
complete and partial response rates of these patients after this therapy. III. Evaluate the
toxicity of this regimen in these patients. IV. Determine the rate of disappearance of cells
with clonal t(14;18)/bcl2 rearrangements from the peripheral blood and bone marrow after
this therapy in these patients.

OUTLINE: Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV, and
vincristine IV on day 1 and oral prednisone on days 1-5. Treatment is repeated every 21 days
for up to 6 courses. Within 4-8 weeks after the last course of chemotherapy, patients who
achieve at least a partial response and have less than 25% bone marrow involvement begin
immunotherapy. Patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over
1 hour, then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1. This regimen is repeated
on day 8. Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.