A Phase II, Open-Label Study of Bortezomib (Velcade), Cladribine and Rituximab (VCR) in Advanced, Newly Diagnosed and Relapsed/Refractory Mantle Cell and Indolent Lymphomas
- Determine the 2-year progression-free survival of patients with advanced mantle cell
lymphoma or indolent lymphoma treated with bortezomib, cladribine, and rituximab.
- Determine the 2-year overall survival of patients treated with this regimen.
- Determine the complete response and overall response rate in patients treated with this
- Describe the long- and short-term toxicity of this regimen in these patients.
- Determine the prognostic importance of Aurora kinase A in patients treated with this
- Determine the cytokine profiles for each lymphoma subtype and how they change with this
- Evaluate the prognostic importance of major carcinogenic pathways using tissue
OUTLINE: Patients receive bortezomib IV on days 1 and 4, cladribine IV over 2 hours on days
1-5, and rituximab IV on day 1. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and after course 1 for cytokine profile studies.
Previously collected tissue samples are obtained for analysis of Aurora kinase A and B,
Ki-67, cyclin D, Bcl-2, phosphor-HisH3, c-Met, and VEGF expression by using tissue
microarray (IHC staining), reverse transcriptase-PCR, and/or western blotting.
After completion of study therapy, patients are followed up every 3 months for 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 2 years
Thomas P. Miller, MD
University of Arizona
United States: Food and Drug Administration
|University of Arizona Cancer Center||Tucson, Arizona 85724|