OBJECTIVES:
* Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.
* Compare the time to disease progression in patients treated with these regimens.
* Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.
* Compare the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:
* Arm I: Patients receive fludarabine IV\* and cyclophosphamide IV\* on days 1-3.
* Arm II: Patients receive rituximab IV on day 1 and fludarabine IV\* and cyclophosphamide IV\* on days 2-4.
NOTE: \*In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for this study.
