A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment
- Assess the efficacy of systemic first-line treatment comprising bortezomib,
cyclophosphamide, vincristine, prednisone, and rituximab, in terms of complete response
rate, in patients with stage III or IV follicular non-Hodgkin's lymphoma.
- Assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy or
neuropathic pain during the first 4 courses of treatment) in patients treated with this
- Assess the overall response rate and response duration in patients treated with this
- Determine progression-free and overall survival of patients treated with this regimen.
- Evaluate the tolerability and characterize the toxicity profile of this regimen in
- Assess quality of life, with particular focus on neurotoxicity-related changes, of
patients treated with this regimen.
OUTLINE: This is a multicenter, nonrandomized, open-label study.
Patient receive cyclophosphamide IV over 15-45 minutes, vincristine IV over 3-5 seconds and
rituximab IV over 1½-6 hours on day 1, oral prednisone daily on days 1-5, and bortezomib IV
over 3-5 seconds on days 1 and 8. Treatment repeats every 3 weeks for up to 8 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of each course of treatment, and on day
42 at the post treatment visit.
After completion of study treatment, patients are followed at 3 and 6 weeks and then every
3-6 months thereafter.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
British Columbia Cancer Agency
Canada: Health Canada