Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)
- To determine the overall response rate, in terms of complete response (CR), unconfirmed
CR, and partial response, in patients with follicular lymphoma or marginal zone
lymphoma treated with rituximab, cyclophosphamide, bortezomib, and prednisone (R-CVelP)
as first line of treatment.
- To determine progression-free survival of patients treated with this regimen.
- To determine overall survival of patients treated with this regimen.
- To determine the safety and tolerance to R-CVelP in these patients.
- Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30
minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days
1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment
repeats every 6 months for up to 4 courses in the absence of disease progression or
After completion of study therapy, patients are followed every 4 months for 1 year, every 6
months for 2 years, and then annually thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate, According to the International Workshop Criteria (IWC)
Denise Pereira, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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