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

Primary Purpose

B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VELCADE and rituximab
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Lymphoma focused on measuring Lymphoma, Non-Hodgkin's, NHL, B-Cell, Indolent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA School of Medicine
  • Florida Cancer Specialists
  • Emory University Cancer Institute, Winship Cancer Institute
  • Georgia Cancer Specialists
  • Rush University Medical Center
  • Midwest Cancer Research Group
  • Cancer Center of Kansas
  • Oncology/Henmatology Associates of Kansas City
  • Mid Ohio Oncology/Hematology Inc.
  • Charleston Cancer Center
  • MD Anderson Cancer Center
  • University of Utah, Huntsman Cancer Institute
  • FNVHO - US Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 11, 2004
Last Updated
February 7, 2008
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00085696
Brief Title
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Official Title
A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma
Keywords
Lymphoma, Non-Hodgkin's, NHL, B-Cell, Indolent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VELCADE and rituximab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Emory University Cancer Institute, Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Cancer Specialists
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Oncology/Henmatology Associates of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mid Ohio Oncology/Hematology Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
FNVHO - US Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
20031
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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