VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
1 other identifier
interventional
152
1 country
35
Brief Summary
The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 2, 2003
CompletedFirst Posted
Study publicly available on registry
July 4, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedFebruary 11, 2008
February 1, 2008
2.5 years
July 2, 2003
February 7, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Confirmed diagnosis of mantle cell lymphoma
- Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
- At least 1 measurable or evaluable site of disease
- Voluntary consent
You may not qualify if:
- Previous treatment with VELCADE
- Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
- Radiation therapy within 3 weeks before the first dose of study drug
- Major surgery with 2 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
- Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug
- History of allergic reactions to boron or mannitol compounds
- Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
- Active systemic infection requiring treatment
- Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Alabama
Birmingham, Alabama, 35294, United States
Alta Bates Medical Center
Berkeley, California, 94704, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Loma Linda Cancer Research Institute
Loma Linda, California, 92354, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94304, United States
University of Colorado Cancer
Denver, Colorado, 80262, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
The Rush Cancer Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospital Division
Iowa City, Iowa, 52242, United States
North Memorial Hospital
Robbinsdale, Minnesota, 55422, United States
Onc/Hem Associates of Kansas City
Kansas City, Missouri, 64111, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Beth Israel Medical Center
New York, New York, 10003, United States
St Lukes-Roosevelt Hospital
New York, New York, 10019, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
New York Hospital Cornell Medical Center
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Wake Forest, University health Sciences/Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University Hospital-Madison Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 2, 2003
First Posted
July 4, 2003
Study Start
June 1, 2003
Primary Completion
December 1, 2005
Last Updated
February 11, 2008
Record last verified: 2008-02