Status:
COMPLETED
Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block canc...
Detailed Description
This is a multicenter, prospective study. * Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of...
Eligibility Criteria
Inclusion
- Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma
- Life expectancy \> 12 months
Exclusion
- 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
Key Trial Info
Start Date :
August 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00369707
Start Date
August 9 2006
End Date
October 10 2014
Last Update
September 6 2019
Active Locations (4)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
2
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497