VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

Study Overview
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Brief Summary
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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 will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

Official Title
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A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

Conditions
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B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma

Intervention / Treatment
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* Drug: VELCADE and rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VELCADE and rituximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Non-Hodgkin's, NHL, B-Cell, Indolent