Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
NCT ID: NCT00057343
Last Updated: 2006-09-12
Study Results
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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TERMINATED
PHASE3
400 participants
INTERVENTIONAL
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Zevalin (ibritumomab tiuxetan)
Rituxan (rituximab)
Eligibility Criteria
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Inclusion Criteria
* Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion \>/= 2.0 cm in a single dimension.
* No lymphoma therapy for 3 weeks prior to Study Day 1.
* Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.
* Signed IRB-approved informed consent.
* Greater than 18 years of age.
* Expected survival \>/= 3 months.
* WHO performance status of \</= 2.
* Acceptable hematologic status, liver function, renal function, and pulmonary function.
* Female patients who are not pregnant or lactating.
* Men and women of reproductive potential who are following accepted birth control methods.
Exclusion Criteria
* Prior radioimmunotherapy, including the Zevalin regimen.
* Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.
* Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was \< 6 months).
* Presence of CNS lymphoma.
* Patients with chronic lymphocytic leukemia (CLL).
* Known history of HIV or AIDS.
* Serious nonmalignant disease or infection
* Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
* Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Locations
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Research Site
Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Concord, California, United States
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Duarte, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Sacramento, California, United States
Biogen Idec Incorporated
San Diego, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Vallejo, California, United States
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Farmington, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Harvey, Illinois, United States
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Maywood, Illinois, United States
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Urbana, Illinois, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Royal Oak, Michigan, United States
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Saint Joseph, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Farmington, New Mexico, United States
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Buffalo, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Bismarck, North Dakota, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Bremerton, Washington, United States
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Morgantown, West Virginia, United States
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Wausau, Wisconsin, United States
Countries
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Other Identifiers
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106-10
Identifier Type: -
Identifier Source: org_study_id