Lymphoma, Non-HodgkinPhase 4NCT00168727
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
A Phase 4 study testing ibritumomab tiuxetan (Zevalin®) in people with Lymphoma, Non-Hodgkin and Lymphoma, Low-Grade, run by Biogen at 8 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
- What is being tested?
- ibritumomab tiuxetan (Zevalin®)
- How many people
- 12 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jun 2003to 31 Oct 2005
- Phase
- Phase 4
- 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
- Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
- No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
- Age >= 18 years, not pregnant or lactating.
- Expected survival >= 3 mths; PS 0, 1, or 2.
- ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
- Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.
- Total lymphocyte count < 5,000/mm3 for SLL.
- <25% bone marrow involvement with lymphoma.
Who cannot join
- Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
- Bulky areas of disease more than 10 cm in diameter.
- Patients with CLL, CNS, or mantle cell lymphoma.
- Hx of HIV/AIDS related lymphoma, hepatitis B or C.
- Prior radioimmunotherapy or XRT to >25% of active bone marrow.
- G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Presbyterian Hospital Cancer Center
Charlotte, North Carolina
Northwest Oncology and Hematology
Elk Grove Village, Illinois
Medical Specialists of Fairfield
Fairfield, Connecticut
Queens Hospital
Honolulu, Hawaii
Horizon Oncolgy Center
Lafayette, Indiana
Loma Linda University
Loma Linda, California
North County Oncology
Oceanside, California
Specialists in Hematology/Oncology
St Louis, Missouri
About this study
Official title: Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.
Read the detailed description
The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
- Being tested
- ibritumomab tiuxetan (Zevalin®)
- Keywords
- Radioimmunotherapy, Antigens, CD20
- 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.
ibritumomab tiuxetan (Zevalin®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
Secondary outcomes (1)
Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start1 Jun 2003
- Study completion31 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wayne Saville, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168727
- Sponsor's protocol ID
- 001-03-ZEV
- Other IDs
- Former Biogen Idec: 106-I001
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2005
- Last updated
- 23 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00168727
- Acronym / sponsor ID
- 001-03-ZEV
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade
- Keywords
- Radioimmunotherapy, Antigens, CD20
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2003 (actual)
- Study completion
- 31 Oct 2005 (actual)
- First posted
- 15 Sep 2005 (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 determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.
Detailed description
The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (8 listed)
- Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
- No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
- Age >= 18 years, not pregnant or lactating.
- Expected survival >= 3 mths; PS 0, 1, or 2.
- ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
Key exclusion criteria (6 listed)
- Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
- Bulky areas of disease more than 10 cm in diameter.
- Patients with CLL, CNS, or mantle cell lymphoma.
- Hx of HIV/AIDS related lymphoma, hepatitis B or C.
- Prior radioimmunotherapy or XRT to >25% of active bone marrow.
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 |
|---|---|---|
| ibritumomab tiuxetan (Zevalin®) | Drug | – |
Primary outcome
Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
1 secondary outcome
Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
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 23 Aug 2023.
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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.
Wayne Saville study director
Biogen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibritumomab tiuxetan (Zevalin®) in people with Lymphoma, Non-Hodgkin and Lymphoma, Low-Grade, run by Biogen at 8 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 8 inclusion and 6 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy. 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 23 Aug 2023.