Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular NHL
1 other identifier
interventional
400
1 country
67
Brief Summary
The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
67 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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2003
CompletedFirst Posted
Study publicly available on registry
April 1, 2003
CompletedSeptember 12, 2006
September 1, 2006
March 31, 2003
September 8, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free survival
Secondary Outcomes (10)
overall response rate
complete response rate
unconfirmed complete response rate
partial response rate
duration of response
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may not qualify if:
- Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.
- 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.
- Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
- 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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (67)
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, 92121, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2003
First Posted
April 1, 2003
Study Start
March 1, 2003
Last Updated
September 12, 2006
Record last verified: 2006-09