Lymphoma, Non-HodgkinPhase 2NCT00240565
Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
A Phase 2 study testing Tositumomab 450 mg and Tositumomab 35 mg in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 11 sites in Canada.
Trial summary
This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Tositumomab 450 mg and Tositumomab 35 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 11 sitesCanada
- Study dates
- Apr 2004to Sep 2011
- 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
- Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
- Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
- Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.
Who cannot join
- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
- Have active obstructive hydronephrosis.
- Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
- Have active infection requiring IV antibiotics.
- Have brain or leptomeningeal metastasis.
- Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
- Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive.
- Other criteria will be evaluated at the screening visit.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N2
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9
GSK Investigational Site
Hamilton, Ontario, L8V 5C2
GSK Investigational Site
Montreal, Quebec, H2L 4M1
GSK Investigational Site
Montreal, Quebec, H4J 1C5
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Québec, Quebec, G1R 2J6
GSK Investigational Site
Québec, Quebec, G1S 4L8
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5G 2M9
About this study
Official title: A Single Arm, Open-label, Multicentre, Phase II Study of Tositumomab and Iodine 131-Tositumomab in Subjects With Indolent Non-Hodgkin's Lymphoma Who Have Previously Received Rituximab.
This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Tositumomab 450 mg, Tositumomab 35 mg
- Keywords
- BEXXAR, non-Hodgkin's Lymphoma, tositumomab, I-131
- 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.
Tositumomab 450 mgDrug
Unlabeled TST
Tositumomab 35 mgDrug
TST labeled with 185 megaBecqueral (mbq) of iodine 131
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation. Receives: Drug: Tositumomab 450 mg; Drug: Tositumomab 35 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Responders are defined as participants with Complete Response (CR: disappearance of all clinical and radiological evidence of lymphoma), Clinical Complete Response (CCR: all criteria met for CR, except there is a residual nodal mass >15 millimeters), or Partial Response (PR: 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.
Measured: Week 26
Secondary outcomes (7)
Complete response rate (CR)
Investigator-assessed confirmed CR is defined as the disappearance of all clinical and radiological evidence of lymphoma. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.
Measured: From the start of treatment (Study Day 0, Baseline) until long-term follow-up (every 6 months until 5 years from the time of study entry)
Duration of response
Duration of response is defined as the time from the first documented response to the first documented disease progression. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation. Disease progression is defined as a 50% increase in the sum of the products of the two perpendicular diameters of all measurable lesions, or the appearance of new lesions.
Measured: 5 years
Progression-free survival (PFS)
PFS is defined as the time interval between the date of the DD to the first date at which progressive disease (PD) or death is observed. PD is defined as a 50% increase in the sum of the products of two perpendicular diameters of all measurable lesions, or the appearance of new lesions. Participants with no evidence of PD were censored to the last date of contact; and those who died for any reason in the absense of PD were classified as having experienced PD on the date of death. For non-responders, duration of PFS was recorded as 0. Participants were censored if they withdrew without PD.
Measured: 5 years or until death
Adverse events
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly in a child from a parent who was exposed to treatment; or is an SAE based on medical or scientific judgement of the investigator.
Measured: 5 years or until death
Quality of Life
Qualty of Life will be asessed utilizing several scales and questionnaires: FACT-G questionnaire was designed to measure multidimensional quality of life (QOL) in participants with cancer. FACT-LymThe FACT-Lym subscale questionnaire is a cancer-specific questionnaire designed to measure multidimensional QOL in participants with lymphoma.
Measured: 5 Years
Resource Utilization Assessment
The Resource Utilization Assessment questionnaires are used to assess the resource utilization of the participant and impacted associates (e.g., family members, caregivers) as well as costs involved to treat participants receiving TST and I 131 TST. As an assessment of general health, participants were asked to rate their activity level on average in the last 7 days on an 11-point scale: 0= exhausted in bed all day; 10=normal activity level.
Measured: Week 26
Duration of Overall Survival
Survival time is defined as the number of weeks from the first study medication administration to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known be alive. If the participant was alive at the time of analysis, then the survival time was censored at the date of last contact.
Measured: 5 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2007
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240565
- Sponsor's protocol ID
- 393229/032
- Status last verified
- Aug 2012
- First submitted
- 14 Oct 2005
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Olney HJ, Freeman MA, Stewart DA, Mangel JE, White DJ, Elia-Pacitti JO. Prolonged progression-free survival and preserved quality of life in the Canadian prospective study of tositumomab and iodine(131)-tositumomab for previously treated, rituximab-exposed, indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2014 Dec;55(12):2754-60. doi: 10.3109/10428194.2014.894190. Epub 2014 Apr 3.
PubMed 24528219
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Multicentre, Phase II Study of Tositumomab and Iodine 131-Tositumomab in Subjects With Indolent Non-Hodgkin's Lymphoma Who Have Previously Received Rituximab.
- ClinicalTrials.gov ID
- NCT00240565
- Acronym / sponsor ID
- 393229/032
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- BEXXAR, non-Hodgkin's Lymphoma, tositumomab, I-131
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Oct 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.
This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tositumomab 450 mg, Drug: Tositumomab 35 mgParticipants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
- Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
- Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.
Key exclusion criteria (8 listed)
- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
- Have active obstructive hydronephrosis.
- Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
- Have active infection requiring IV antibiotics.
- Have brain or leptomeningeal metastasis.
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 |
|---|---|---|
| Tositumomab 450 mgUnlabeled TST | Drug | Arm 1 |
| Tositumomab 35 mgTST labeled with 185 megaBecqueral (mbq) of iodine 131 | Drug | Arm 1 |
Primary outcome
Response Rate
Time frame: Week 26
Responders are defined as participants with Complete Response (CR: disappearance of all clinical and radiological evidence of lymphoma), Clinical Complete Response (CCR: all criteria met for CR, except there is a residual nodal mass >15 millimeters), or Partial Response (PR: 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.
7 secondary outcomes
Complete response rate (CR)
Time frame: From the start of treatment (Study Day 0, Baseline) until long-term follow-up (every 6 months until 5 years from the time of study entry)
Duration of response
Time frame: 5 years
Progression-free survival (PFS)
Time frame: 5 years or until death
Adverse events
Time frame: 5 years or until death
Quality of Life
Time frame: 5 Years
Resource Utilization Assessment
Time frame: Week 26
Duration of Overall Survival
Time frame: 5 years or until death
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 13 Aug 2012.
- Derived from this study: PubMed 24528219Olney HJ, Freeman MA, Stewart DA, Mangel JE, White DJ, Elia-Pacitti JO. Prolonged progression-free survival and preserved quality of life in the Canadian prospective study of tositumomab and iodine(131)-tositumomab for previously treated, rituximab-exposed, indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2014 Dec;55(12):2754-60. doi: 10.3109/10428194.2014.894190. Epub 2014 Apr 3.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tositumomab 450 mg and Tositumomab 35 mg in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 11 sites 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 3 inclusion and 8 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 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 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?
Response Rate (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240565, which also lists 1 linked publication.
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 13 Aug 2012.