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VELCADE® (Bortezomib) With R...

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

Last Updated: 2008-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

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.

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Detailed Description

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Conditions

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B-Cell Lymphoma Follicular Lymphoma Marginal Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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VELCADE and rituximab

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers