National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
- 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
- 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
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or
PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Simon Rule, MD
United States: Federal Government