Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma Life expectancy > 12 months Exclusion Criteria: No known history of HIV infection No other active infection No peripheral neuropathy ≥ grade 2 within the past 14 days No uncontrolled hypertension None of the following cardiac conditions: Myocardial infarction within the past 6 months No heart failure Uncontrolled angina Severe uncontrolled ventricular arrhythmias Electrocardiographic evidence of acute ischemia Active conduction system abnormalities No serious medical or psychiatric illness that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior therapy for non-Hodgkins lymphoma No prior bortezomib or rituximab At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy At least 2 weeks since prior investigational drugs No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Hematology-Oncology Associates of Illinois
- Northwestern University
- Fox Chase Cancer Center - Philadelphia
Arms of the Study
Arm 1
Experimental
Bortezomib and Rituximab
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.