LymphomaPhase 2NCT00414089
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL
A Phase 2 study testing 90Y-ibritumomab tiuxetan (Zevalin) in people with Lymphoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- 90Y-ibritumomab tiuxetan (Zevalin)
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 indolent lymphoma including:
- follicular grade 1 or 2
- small lymphocytic
- marginal zone (nodal)
- marginal zone (splenic)
- mucosa associated lymphoid tissue (MALT)
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- no evidence of transformation
- Stage III or IV disease
- No prior therapy
- involvement by less than 25% of bone marrow on assessment of trephine biopsy
- absolute lymphocyte count ≤ x 109/L
- platelets ≥ 150 x 109/L
- hemoglobin ≥ 100g/L
- absolute neutrophil count ≥ 1.5 x 109/L
- at least one bidimensionally measurable lesion at least 2cm by CT scanning
Who cannot join
- any other anticancer treatment for NHL
- prior radiation therapy
- prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
- no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
- presence of central nervous system lymphoma
- patients known to be HIV positive
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- patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
- patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN
- patients with abnormal renal function: serum creatinine > 2.5X ULN
- known hypersensitivity to murine antibodies or proteins
- immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.
- Conditions
- Lymphoma
- Being tested
- 90Y-ibritumomab tiuxetan (Zevalin)
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-ibritumomab tiuxetan (Zevalin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Secondary outcomes (1)
Progression free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
Why it stopped: Funding will not be provided for the drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Belch, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414089
- Sponsor's protocol ID
- HE-10-0100
- Status last verified
- Jul 2007
- First submitted
- 19 Dec 2006
- Last updated
- 15 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00414089
- Acronym / sponsor ID
- HE-10-0100
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding will not be provided for the drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- First posted
- 21 Dec 2006 (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 see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.
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 (15 listed)
- histologically confirmed indolent lymphoma including:
- no evidence of transformation
- Stage III or IV disease
- No prior therapy
- involvement by less than 25% of bone marrow on assessment of trephine biopsy
Key exclusion criteria (11 listed)
- any other anticancer treatment for NHL
- prior radiation therapy
- prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
- no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
- presence of central nervous system 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 |
|---|---|---|
| 90Y-ibritumomab tiuxetan (Zevalin) | Drug | – |
Primary outcome
Response
1 secondary outcome
Progression free survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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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.
Andrew Belch, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 90Y-ibritumomab tiuxetan (Zevalin) in people with Lymphoma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 15 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Feb 2016. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Response. 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 15 Feb 2016.