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PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders.
- Determine the frequency and duration of complete and partial response rates in patients with grade I, II, or III folicular lymphoma or mantle cell lymphoma treated with bortezomib.
- Determine the response of minimal residual disease by polymerase chain reaction (PCR) detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle cell lymphoma).
Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
Patients are followed every 3 months for 1 year and then every 4 months for 2 years.
PROJECTED ACCRUAL: Approximately 105 patients (6-23 per stratum) will be accrued for this study within 9-18 months.
Masking: Open Label, Primary Purpose: Treatment
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:34:25-0400
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