Lymphoma, Non-HodgkinPhase 3NCT00268983
Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
A Phase 3 study testing Tositumomab and Iodine I 131 Tositumomab and Rituximab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial summary
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 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 and Iodine I 131 Tositumomab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2004to Jun 2013
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of follicular lymphoma
- Recurrent lymphoma after one or two qualifying therapy regimen(s)
- Patients must not have progressed within 4 weeks of their last chemotherapy dose
- Rituximab may have been used once as a single agent, in one continuous course of 4-8 weekly infusions (10-week period), or in combination with chemotherapy in a single prior treatment
- Patients whose prior therapy includes rituximab must have had a 6 month or greater response duration following the rituximab-containing regimen.
- Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months
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- Adequate absolute neutrophil count and platelet count within 21 days of study entry without support of blood products/growth factors
- Adequate renal function and adequate hepatic within 21 days of study entry
- Measurable disease, with at least one lesion measuring >/=2.0 cm x 2.0 cm by CT scan
- Human Anti Mouse Antigen negative
- Written informed consent prior to study entry
Who cannot join
- Histologic transformation to diffuse, large cell lymphoma.
- History of more than one course of Rituximab
- Disease limited to single lymph node or single group of nodes
- Involvement of 25% of the intratrabecular marrow by bone marrow biopsy specimen.
- Active infection requiring IV antibiotics at the time of study entry
- New York Heart Association Class III/IV heart disease
Show all 12Show fewer
- Prior chemotherapy, biologic, radiation or steroid therapy for NHL within 8 weeks
- Any prior radioimmunotherapy
- Prior history of malignancy other than lymphoma (except for treated basal cell, squamous cell skin cancer, in situ cervical cancer, or other cancer that is disease-free for 5 years)
- Known HIV infection
- Hepatitis B positive
- Known central nervous system involvement
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
GSK Investigational Site
Walla Walla, Washington, 99362
About this study
Official title: A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the "therapeutic dose," subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Tositumomab and Iodine I 131 Tositumomab, Rituximab
- Keywords
- rituximab, tositumomab and iodine I 131 tositumomab, non-Hodgkins lymphoma, radioimmunotherapy, anti-B1 antibody, Bexxar, NHL, Tositumomab
- 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 and Iodine I 131 TositumomabBiological
Also called Bexxar Therapeutic Regimen, anti-B1 Antibody, Iodine I 131 Tositumomab
Dosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes
Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes.
RituximabBiological
Rituximab 375 mg/m2 given as an IV infusion once weekly for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tositumomab and Iodine I 131 Tositumomab | Experimental | Dosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes
Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes. Receives: Biological: Tositumomab and Iodine I 131 Tositumomab |
| Rituximab | Active comparator | Rituximab 375 mg/m2 given as an IV infusion once weekly for four weeks. Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.
Measured: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Progression-free Survival
Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.
Measured: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Secondary outcomes (16)
Number of Participants Achieving Response
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer
Measured: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually
Duration of Response
Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.
Measured: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually
Time to Death
Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled "Number of Participants Who Had Died by the Month Indicated" for data regarding time to death.
Measured: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants Who Had Died by the Month Indicated
The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.
Measured: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Time to Next Treatment
Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.
Measured: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Absolute Neutrophil Count
Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.
Measured: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Hemoglobin
Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.
Measured: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count
Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.
Measured: Time from study randomization to 120 days after study drug administration
Time to Nadir Values for the Indicated Hematological Parameters
Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.
Measured: Time from study randomization to 120 days after study drug administration
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters
Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.
Measured: Time from study randomization to 120 days after study drug administration
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters
Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death
Measured: Time from study randomization to 120 days after study drug administration
Number of Participants That Developed Hypothyroidism
Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.
Measured: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants With an Infusion Reaction
An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: First 24 hours of study drug administration.
Number of Hospitalizations
The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.
Measured: Time of treatment until 90 days post-treatment
Number of Participants With Myelodysplasia/Leukemia
The cumulative incidence of myelodysplasia/leukemia was estimated.
Measured: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be 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 SAE is defined as 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/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: From randomization through Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2009
- Study completionJun 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT00268983
- Sponsor's protocol ID
- 393229/028
- Status last verified
- Nov 2016
- First submitted
- 21 Dec 2005
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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.
Publications
Quackenbush RC, Horner TJ, Williams VC, Giampietro P, Lin TS. Patients with relapsed follicular lymphoma treated with rituximab versus tositumomab and iodine I-131 tositumomab. Leuk Lymphoma. 2015 Mar;56(3):779-81. doi: 10.3109/10428194.2014.927461. Epub 2014 Jul 23. No abstract available.
PubMed 24898665
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
- A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
- ClinicalTrials.gov ID
- NCT00268983
- Acronym / sponsor ID
- 393229/028
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- rituximab, tositumomab and iodine I 131 tositumomab, non-Hodgkins lymphoma, radioimmunotherapy, anti-B1 antibody, Bexxar, NHL, Tositumomab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Posted 2 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the "therapeutic dose," subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tositumomab and Iodine I 131 Tositumomab | Experimental | Biological: Tositumomab and Iodine I 131 TositumomabDosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes. |
| Rituximab | Active comparator | Biological: RituximabRituximab 375 mg/m2 given as an IV infusion once weekly for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of follicular lymphoma
- Recurrent lymphoma after one or two qualifying therapy regimen(s)
- Patients must not have progressed within 4 weeks of their last chemotherapy dose
- Rituximab may have been used once as a single agent, in one continuous course of 4-8 weekly infusions (10-week period), or in combination with chemotherapy in a single prior treatment
- Patients whose prior therapy includes rituximab must have had a 6 month or greater response duration following the rituximab-containing regimen.
Key exclusion criteria (12 listed)
- Histologic transformation to diffuse, large cell lymphoma.
- History of more than one course of Rituximab
- Disease limited to single lymph node or single group of nodes
- Involvement of 25% of the intratrabecular marrow by bone marrow biopsy specimen.
- Active infection requiring IV antibiotics at the time of study entry
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 and Iodine I 131 TositumomabAlso: Bexxar Therapeutic Regimen, anti-B1 Antibody, Iodine I 131 TositumomabDosimetric dose: 450 mg Tositumomab infused over 1 hour followed by 5 mCi I 131 Tositumomab infused over 20 minutes Therapeutic dose: 450 mg Tositumomab infused over 1 hour followed by Individualized mCi activity of I 131 Tositumomab (35 mg) infused over 20 minutes. | Biological | Tositumomab and Iodine I 131 Tositumomab |
| RituximabRituximab 375 mg/m2 given as an IV infusion once weekly for four weeks. | Biological | Rituximab |
Primary outcome
Event-free Survival (EFS)
Time frame: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.
Progression-free Survival
Time frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.
16 secondary outcomes
Number of Participants Achieving Response
Time frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually
Duration of Response
Time frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually
Time to Death
Time frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants Who Had Died by the Month Indicated
Time frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Time to Next Treatment
Time frame: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Absolute Neutrophil Count
Time frame: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Hemoglobin
Time frame: Time from study randomization to 120 days after study drug administration
Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count
Time frame: Time from study randomization to 120 days after study drug administration
Time to Nadir Values for the Indicated Hematological Parameters
Time frame: Time from study randomization to 120 days after study drug administration
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters
Time frame: Time from study randomization to 120 days after study drug administration
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters
Time frame: Time from study randomization to 120 days after study drug administration
Number of Participants That Developed Hypothyroidism
Time frame: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants With an Infusion Reaction
Time frame: First 24 hours of study drug administration.
Number of Hospitalizations
Time frame: Time of treatment until 90 days post-treatment
Number of Participants With Myelodysplasia/Leukemia
Time frame: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)
Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)
Time frame: From randomization through Week 26
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.
- Derived from this study: PubMed 24898665Quackenbush RC, Horner TJ, Williams VC, Giampietro P, Lin TS. Patients with relapsed follicular lymphoma treated with rituximab versus tositumomab and iodine I-131 tositumomab. Leuk Lymphoma. 2015 Mar;56(3):779-81. doi: 10.3109/10428194.2014.927461. Epub 2014 Jul 23. No abstract available.
- 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tositumomab and Iodine I 131 Tositumomab and Rituximab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 3 sites in 3 countries.
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 11 inclusion and 12 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.
Where is the study taking place?
The record lists 3 sites in United States, France, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Aug 2010). 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?
Event-free Survival (EFS) (time frame: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)). The study lists 2 primary outcomes in all. 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 NCT00268983, 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 9 Jan 2017.