Non-Hodgkin's Lymphoma (NHL)ZEVALIN-DUINCT01448928
Zevalin Post-marketing Surveillance in Japan
An observational study of Non-Hodgkin's Lymphoma (NHL), run by Spectrum Pharmaceuticals, Inc at 1 site in Japan.
Trial summary
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. 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?
- [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2008to 31 Jan 2018
- 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: 400cases: This study is all case investigation of which the enrollment period is five years, and all patients who received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma will be recruited.
Who may be able to join
- Patients who received Zevalin for relapsed or refractory:
- CD20+
- low grade B-cell non-Hodgkin's lymphoma
- Mantle cell lymphoma
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: Drug Use Investigation of Zevalin
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Being tested
- [90]Y-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.
[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)Drug
Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions in subjects who received Zevalin
Measured: After In-111 Zevalin administration, up to 13 weeks
Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
Measured: After In-111 Zevalin administration, up to 8 years
Secondary outcomes (7)
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]
Measured: After In-111 Zevalin administration, up to 13 weeks
Effectiveness evaluation assessment [complete remission rate, complete remission uncertain rate, partial remission rate, stable disease rate, progression disease rate] by investigator-determined overall best response
Measured: After In-111 Zevalin administration, up to 13 weeks
Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response
Measured: After In-111 Zevalin administration, up to 8 years
Change in hemoglobin from baseline
Measured: After In-111 Zevalin administration, up to 13 weeks
Change in neutrophil from baseline
Measured: After In-111 Zevalin administration, up to 13 weeks
Change in platelet from baseline
Measured: After In-111 Zevalin administration, up to 13 weeks
Change in leukocyte from baseline
Measured: After In-111 Zevalin administration, up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2008
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448928
- Sponsor's protocol ID
- 15042
- Acronym
- ZEVALIN-DUI
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2011
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Zevalin
- ClinicalTrials.gov ID
- NCT01448928
- Acronym / sponsor ID
- ZEVALIN-DUI / 15042
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Keywords
- Zevalin, CD20+, Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Sep 2008 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 7 Oct 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 in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 400cases: This study is all case investigation of which the enrollment period is five years, and all patients who received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma will be recruited.
Key inclusion criteria (4 listed)
- CD20+
- low grade B-cell non-Hodgkin's lymphoma
- Mantle cell lymphoma
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 |
|---|---|---|
| [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. | Drug | Group 1 |
Primary outcome
Incidence of adverse drug reactions in subjects who received Zevalin
Time frame: After In-111 Zevalin administration, up to 13 weeks
Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
Time frame: After In-111 Zevalin administration, up to 8 years
7 secondary outcomes
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]
Time frame: After In-111 Zevalin administration, up to 13 weeks
Effectiveness evaluation assessment [complete remission rate, complete remission uncertain rate, partial remission rate, stable disease rate, progression disease rate] by investigator-determined overall best response
Time frame: After In-111 Zevalin administration, up to 13 weeks
Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response
Time frame: After In-111 Zevalin administration, up to 8 years
Change in hemoglobin from baseline
Time frame: After In-111 Zevalin administration, up to 13 weeks
Change in neutrophil from baseline
Time frame: After In-111 Zevalin administration, up to 13 weeks
Change in platelet from baseline
Time frame: After In-111 Zevalin administration, up to 13 weeks
Change in leukocyte from baseline
Time frame: After In-111 Zevalin administration, up to 13 weeks
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 1 Oct 2021.
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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.
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 Spectrum Pharmaceuticals, Inc 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 4 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 1 Oct 2021. 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?
Incidence of adverse drug reactions in subjects who received Zevalin (time frame: After In-111 Zevalin administration, up to 13 weeks). 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 1 Oct 2021.