Lymphoma Clinical Trial
Official title:
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. It is not yet known if combination chemotherapy is more effective with or without
rituximab in treating mantle cell lymphoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and
cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone
in treating patients who have mantle cell lymphoma.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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