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

February 7, 2008 updated by: Millennium Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: VELCADE and rituximab

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90095
    - UCLA School of Medicine
- Florida
  - Fort Myers, Florida, United States, 33901
    - Florida Cancer Specialists
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Cancer Institute, Winship Cancer Institute
  - Marietta, Georgia, United States, 30060
    - Georgia Cancer Specialists
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Skokie, Illinois, United States, 60077
    - Midwest Cancer Research Group
- Kansas
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Oncology/Henmatology Associates of Kansas City
- Ohio
  - Columbus, Ohio, United States, 43213
    - Mid Ohio Oncology/Hematology Inc.
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - Charleston Cancer Center
- Texas
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center
- Utah
  - Salt Lake City, Utah, United States, 84112
    - University of Utah, Huntsman Cancer Institute
- Virginia
  - Fairfax, Virginia, United States, 20031
    - FNVHO - US Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

June 11, 2004

First Submitted That Met QC Criteria

June 14, 2004

First Posted (Estimate)

June 15, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M34103-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.