Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I/II Study Evaluating Rituximab, Lenalidomide, and Bortezomib in the First-Line or Second-Line Treatment of Patients With Mantle Cell Lymphoma
This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).
The combination of lenalidomide with bortezomib has not been studied in patients with MCL,
but feasibility and tolerability has been demonstrated in patients with multiple myeloma.
Thus, almost every 2-drug combination of rituximab, lenalidomide, and bortezomib has been
tested, or is being tested. We hypothesize that all three drugs are important in MCL, and
therefore propose to combine all 3 agents (rituximab, bortezomib, and lenalidomide) in a
schedule that is convenient to lymphoma patients.
Approximately 18 patients may be enrolled in the Phase I portion of the study. Approximately
45 patients are planned for enrollment in Phase II.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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