Lymphoma Clinical Trial
Official title:
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill
them or deliver cancer-killing substances to them without harming normal cells. Drugs used
in chemotherapy use different way to stop cancer cells from dividing so they stop growing or
die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating
patients who have Waldenstrom's macroglobulinemia.
OBJECTIVES:
- Determine the objective response and time to treatment failure in patients with
Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
- Determine the toxicity of this regimen in these patients.
- Determine if molecular remissions are achievable in patients attaining a clinical
complete response when treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31
and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and
27.
Patients are followed at least every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
;
Primary Purpose: Treatment
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