Lymphoma, FollicularNCT01164696
A Prospective Observational Study to Evaluate the Quality of Life and the Costs in a Real Life Setting in Patients Who Are Treated With 90Y-Zevalin
An observational study of Lymphoma, Follicular and Non-Hodgkin Lymphoma, run by Bayer at 1 site in Belgium.
Trial summary
The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular, Non-Hodgkin Lymphoma
- What is being tested?
- [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2007to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with relapsed or refractory FL who have been treated with 90Y-Zevalin in Belgium within the first 24 months after ethics approval
Who may be able to join
- Advanced cancer of the lymph nodes of follicular type at study inclusion
- The patient has relapsed or has refractory disease, after previous treatment with rituximab
- Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
- The patient is >= 18 years of age
- Patient has given informed consent
Who cannot join
- Patient is unwilling or unable to give informed consent
- Patient is participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin
The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.
- Conditions
- Lymphoma, Follicular, Non-Hodgkin Lymphoma
- Being tested
- [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Keywords
- Quality of Life, Health Care Costs
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin
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
Zevalin was administered according to the directives in the approved package leaflet.
| 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.
The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
Measured: one year after inclusion
Secondary outcomes (2)
the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)
Measured: baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
the clinical outcomes (survival status, response status), TTNT (time to next treatment)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT01164696
- Sponsor's protocol ID
- 13455
- Other IDs
- ZV0710BE
- Status last verified
- Aug 2010
- First submitted
- 16 Jul 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin
- ClinicalTrials.gov ID
- NCT01164696
- Acronym / sponsor ID
- 13455
- Conditions
- Lymphoma, Follicular, Non-Hodgkin Lymphoma
- Keywords
- Quality of Life, Health Care Costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Jul 2010 (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 objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with relapsed or refractory FL who have been treated with 90Y-Zevalin in Belgium within the first 24 months after ethics approval
Key inclusion criteria (5 listed)
- Advanced cancer of the lymph nodes of follicular type at study inclusion
- The patient has relapsed or has refractory disease, after previous treatment with rituximab
- Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
- The patient is >= 18 years of age
- Patient has given informed consent
Key exclusion criteria (2 listed)
- Patient is unwilling or unable to give informed consent
- Patient is participating in another clinical trial
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)Zevalin was administered according to the directives in the approved package leaflet. | Drug | Group 1 |
Primary outcome
The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
Time frame: one year after inclusion
2 secondary outcomes
the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)
Time frame: baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
the clinical outcomes (survival status, response status), TTNT (time to next treatment)
Time frame: 1 year
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 Aug 2010.
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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 Lymphoma, Follicular and Non-Hodgkin Lymphoma, run by Bayer at 1 site in Belgium.
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 5 inclusion and 2 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 Aug 2010. 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 Belgium. 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?
The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment (time frame: one year after inclusion). 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 Aug 2010.