Non-Hodgkin's Lymphoma (NHL)ZEVALIN-SDUINCT01479387
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
An observational study of Non-Hodgkin's Lymphoma (NHL), run by Bayer at 1 site in Japan.
Trial summary
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin's Lymphoma (NHL)
- What is being tested?
- [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Feb 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.
Who may be able to join
- Patients who received In-111 Zevalin to verify that expected biodistribution is present.
Who cannot join
- Patients who are contraindicated based on the product label.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Zevalin
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Being tested
- [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Keywords
- Zevalin, CD20+, Non-Hodgkin's lymphoma, Mantle cell lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)Drug
Patients who have received In-111 Zevalin.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
Measured: At 48-72 hours after In-111 Zevalin injection
Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]
Measured: At 48-72 hours after In-111 Zevalin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startAug 2008
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479387
- Sponsor's protocol ID
- 15043
- Acronym
- ZEVALIN-SDUI
- Status last verified
- Nov 2011
- First submitted
- 11 Aug 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Zevalin
- ClinicalTrials.gov ID
- NCT01479387
- Acronym / sponsor ID
- ZEVALIN-SDUI / 15043
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Keywords
- Zevalin, CD20+, Non-Hodgkin's lymphoma, Mantle cell lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Nov 2011 (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.
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.
Key inclusion criteria (1 listed)
- Patients who received In-111 Zevalin to verify that expected biodistribution is present.
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label.
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 |
|---|---|---|
| [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)Patients who have received In-111 Zevalin. | Drug | Group 1 |
Primary outcome
Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
Time frame: At 48-72 hours after In-111 Zevalin injection
Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]
Time frame: At 48-72 hours after In-111 Zevalin injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma (NHL), run by Bayer at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No] (time frame: At 48-72 hours after In-111 Zevalin injection). The study lists 2 primary outcomes in all. 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 24 Nov 2011.