Lymphoma, Non-HodgkinPhase 2NCT00268203
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
A Phase 2 study testing Iodine I 131 Tositumomab Therapeutic Regimen in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.
Trial summary
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. 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?
- Iodine I 131 Tositumomab Therapeutic Regimen
- How many people
- 765 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
- Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
- Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
- Absolute granulocyte of >/= 1,500/mm3.
- Platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
- Adequate renal function (i.e., <1.5x Upper Limit of Normal), and hepatic transaminases (AST <5 times ULN).
- Signed IRB/IEC-approved informed consent.
Who cannot join
- Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
- Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
- Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
- Known HIV infection.
- Pregnant or nursing patients.
- Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
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- Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
- Patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, HAMA positivity.
- Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
About this study
Official title: Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Iodine I 131 Tositumomab Therapeutic Regimen
- Keywords
- expanded access study, refractory low-grade non-Hodgkin's Lymphoma, Bexxar®, Iodine I 131 Tositumomab, EAP, relapsed low-grade non-Hodgkin's lymphoma
- 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.
Iodine I 131 Tositumomab Therapeutic RegimenBiological
Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Measured: From randomization until the first documented complete response or partial response (up to 161 months)
Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Measured: From randomization until the first documented complete response or partial response (up to 161 months)
Duration of Response for Participants With Unconfirmed Response (CR+PR)
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Measured: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of Response for Participants With Confirmed Response (CR+PR)
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Measured: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of Response (DOR) in Unconfirmed Complete Responders
DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Measured: From the time of the first documented unconfirmed CR until PD (up to 161 months)
Duration of Response (DOR) in Confirmed Complete Responders
DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Measured: From the time of the first documented CR until PD (up to 161 months)
Time to Progression or Death
Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.
Measured: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)
Secondary outcomes (1)
Time to Treatment Failure
Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.
Measured: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startSep 1998
- Primary completionMar 2000
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Enrolment
- 765 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
- NCT00268203
- Sponsor's protocol ID
- BEX104545
- Status last verified
- Nov 2016
- First submitted
- 20 Dec 2005
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00268203
- Acronym / sponsor ID
- BEX104545
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- expanded access study, refractory low-grade non-Hodgkin's Lymphoma, Bexxar®, Iodine I 131 Tositumomab, EAP, relapsed low-grade non-Hodgkin's lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Mar 2000 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Posted 9 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
- Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
- Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
- Absolute granulocyte of >/= 1,500/mm3.
- Platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
Key exclusion criteria (9 listed)
- Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
- Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
- Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
- Known HIV infection.
- Pregnant or nursing patients.
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 |
|---|---|---|
| Iodine I 131 Tositumomab Therapeutic RegimenPatients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose. | Biological | – |
Primary outcome
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
Time frame: From randomization until the first documented complete response or partial response (up to 161 months)
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
Time frame: From randomization until the first documented complete response or partial response (up to 161 months)
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Duration of Response for Participants With Unconfirmed Response (CR+PR)
Time frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Duration of Response for Participants With Confirmed Response (CR+PR)
Time frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Duration of Response (DOR) in Unconfirmed Complete Responders
Time frame: From the time of the first documented unconfirmed CR until PD (up to 161 months)
DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Duration of Response (DOR) in Confirmed Complete Responders
Time frame: From the time of the first documented CR until PD (up to 161 months)
DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Time to Progression or Death
Time frame: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)
Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.
1 secondary outcome
Time to Treatment Failure
Time frame: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iodine I 131 Tositumomab Therapeutic Regimen in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.
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 7 inclusion and 9 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response (time frame: From randomization until the first documented complete response or partial response (up to 161 months)). The study lists 7 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 9 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.