A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma
- To assess tumor response in patients with relapsed or refractory low-grade follicular
lymphoma (grade I or II), mantle cell lymphoma, or lymphoplasmacytic lymphoma
(Waldenstrom macroglobulinemia) treated with rituximab, cyclophosphamide, bortezomib,
- To evaluate overall survival, progression-free survival, duration of response, and time
to treatment failure in patients treated with this regimen.
- To describe the adverse event profile (as assessed by NCI CTCAE version 3.0) of this
regimen in these patients.
- To evaluate the quality of life, in terms of patient-reported neurotoxicity, in
patients treated with this regimen.
OUTLINE: Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and
oral cyclophosphamide and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
Patients complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire,
version 4.0) at baseline, on day 1 of courses 3, 6, and 9, and at the completion of study
After completion of study treatment, patients are followed every 3-6 months for up to 5
Masking: Open Label, Primary Purpose: Treatment
Proportion of responses (complete response or partial response)
Craig B. Reeder, M.D.
United States: Food and Drug Administration
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