Trial Information

A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

OBJECTIVES:

- Compare the progression-free survival and overall survival of patients with newly
diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131
tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to
accrual as of 12/15/02)

- Compare the response rate of these patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Compare the molecular remission rates of this patient population treated with these
regimens.

- Determine the incidence and time to development of human anti-mouse antibody
positivity.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
whether microglobulin is greater than upper limit of normal (yes vs no). Patients are
randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)

- Arm I (CHOP only): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV
over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive
oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6
courses in the absence of disease progression or unacceptable toxicity. (Arm I closed
to accrual as of 12/15/02)

- Arm II (CHOP + rituximab): Patients receive cyclophosphamide IV over 15 minutes,
doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29,
50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33,
50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134,
and 141.

- Arm III (CHOP + tositumomab): Patients receive chemotherapy as in arm I and tositumomab
(monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV
over 20 minutes on days 134 and 141.

Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually
thereafter.

PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for
this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)