Status:
COMPLETED
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
B-Cell Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study w...
Eligibility Criteria
Inclusion
- Male or female subject 18 years or older
- Diagnosis of B-cell lymphoma (CD20+) of
- follicular lymphoma (grades 1, 2, and 3) or
- marginal zone lymphoma (extranodal, nodal, and splenic)
- Documented relapse or progression following prior anti-neoplastic treatment.
- At least 1 measurable lymph node mass that is \>1.5 cm.
- No active CNS lymphoma
- Voluntary consent
Exclusion
- Previous treatment with VELCADE
- Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
- Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
- Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
- Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
- Radiation therapy within 3 weeks before the first dose of study drug.
- Major surgery within 2 weeks before the first dose of study drug.
- Peripheral neuropathy or neuropathic pain
- History of allergic reaction attributable to compounds containing boron or mannitol
- Known anaphylaxis or hypersensitivity to any component of rituximab
- Diagnosed or treated for a selected malignancies other than NHL within 5 years.
- Active systemic infection requiring treatment
- Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
- Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
- Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00085696
Start Date
May 1 2004
Last Update
February 11 2008
Active Locations (13)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095
2
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
3
Emory University Cancer Institute, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
4
Georgia Cancer Specialists
Marietta, Georgia, United States, 30060