Non-Hodgkin's LymphomaPhase 3NCT00057343
Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
A Phase 3 study testing Zevalin (ibritumomab tiuxetan) and Rituxan (rituximab) in people with Non-Hodgkin's Lymphoma, run by Biogen at 67 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Zevalin (ibritumomab tiuxetan) and Rituxan (rituximab)
- How many people
- 400 participants
- Where
- 67 sitesUnited States
- Study dates
- Mar 2003to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
- Presence of CNS lymphoma.
- Patients with chronic lymphocytic leukemia (CLL).
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- 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.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Research Site
Albuquerque, New Mexico
Research Site
Ann Arbor, Michigan
Research Site
Aurora, Illinois
Research Site
Bakersfield, California
Research Site
Baltimore, Maryland
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Bismarck, North Dakota
Research Site
Boise, Idaho
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Boston, Massachusetts
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Bremerton, Washington
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Buffalo, New York
Research Site
Charleston, South Carolina
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Chicago, Illinois
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Cleveland, Ohio
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Coeur d'Alene, Idaho
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Columbia, Missouri
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Concord, California
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Detroit, Michigan
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Duarte, California
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Evanston, Illinois
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Farmington, Connecticut
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Farmington, New Mexico
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Flint, Michigan
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Greenville, South Carolina
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Harvey, Illinois
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Jackson, Mississippi
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Jacksonville, Florida
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Kansas City, Kansas
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Kansas City, Missouri
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Lakeland, Florida
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Little Rock, Arkansas
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Loma Linda, California
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Los Angeles, California
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Lubbock, Texas
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Manhasset, New York
Research Site
Maywood, Illinois
Research Site
Minneapolis, Minnesota
Research Site
Mission Viejo, California
Research Site
Morgantown, West Virginia
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Munster, Indiana
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Nashville, Tennessee
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New York, New York
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Newark, Delaware
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Newport Beach, California
Research Site
Orange, California
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Portland, Oregon
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Rochester, Minnesota
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Royal Oak, Michigan
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Sacramento, California
Research Site
Saint Joseph, Michigan
Research Site
Salt Lake City, Utah
Biogen Idec Incorporated
San Diego, California, 92121
Research Site
San Diego, California
Research Site
Santa Barbara, California
Research Site
Scottsdale, Arizona
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St Louis, Missouri
Research Site
Temple, Texas
Research Site
The Bronx, New York
Research Site
Toledo, Ohio
Research Site
Tupelo, Mississippi
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Urbana, Illinois
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Vallejo, California
Research Site
Wausau, Wisconsin
About this study
Official title: 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
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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Zevalin (ibritumomab tiuxetan), Rituxan (rituximab)
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zevalin (ibritumomab tiuxetan)Drug
Rituxan (rituximab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Secondary outcomes (10)
overall response rate
complete response rate
unconfirmed complete response rate
partial response rate
duration of response
time to progression
time-to-next anticancer therapy
quality of life
overall survival
safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2003 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057343
- Sponsor's protocol ID
- 106-10
- Status last verified
- Sep 2006
- First submitted
- 31 Mar 2003
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00057343
- Acronym / sponsor ID
- 106-10
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 1 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
- Presence of CNS lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zevalin (ibritumomab tiuxetan) | Drug | – |
| Rituxan (rituximab) | Drug | – |
Primary outcome
Event-free survival
10 secondary outcomes
overall response rate
complete response rate
unconfirmed complete response rate
partial response rate
duration of response
time to progression
time-to-next anticancer therapy
quality of life
overall survival
safety profile
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zevalin (ibritumomab tiuxetan) and Rituxan (rituximab) in people with Non-Hodgkin's Lymphoma, run by Biogen at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.