Lymphoma, FollicularPhase 1NCT00315731
A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma
A Phase 1 study testing Follicular Lymphoma in people with Lymphoma, Follicular, run by GlaxoSmithKline.
Trial summary
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Follicular Lymphoma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2003to 30 Jun 2013
- Phase
- Phase 1
- 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
- At least 18 years of age
- A histologically confirmed diagnosis of the following:
- Follicular lymphoma, Grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (World Health Organization/Revised European-American Lymphoma [WHO/REAL] classification).
- International Working Formulation histological equivalents included:
- Follicular, small-cleaved; Follicular, mixed small-cleaved and large-cell; Follicular large-cell; or Transformed diffuse large-cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
- Stage III or IV disease at the time of study entry (based on Ann Arbor Staging Classification)
Show all 14Show fewer
- Previously untreated or recurrent lymphoma after no more than 4 prior qualifying therapy regimens; steroids alone, as treatment for lymphoma, not considered a treatment regimen
- Performance status of at least 70% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
- Bi dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (greater than or equal to 4.0 cm2) by computed tomography (CT) scan
- Absolute B lymphocyte count (as determined by CD19 reactivity [flow cytometric determination of CD19+ B lymphocyte count]) of 30 to 350 cell/mm3 within 21 days prior to study enrollment
- Absolute neutrophil count greater than or equal to 1500 cells/mm3; platelet count greater than or equal to 150,000/mm3; and hemoglobin greater than or equal to 10 g/dL within 21 days prior to study enrollment; blood products and/or growth factors not taken within 4 weeks prior to blood draw
- Adequate renal function, defined as serum creatinine <1.5 x upper limit of normal (ULN), and hepatic function, defined as total bilirubin <1.5 x ULN and aspartate transaminase (AST) <5 x ULN, within 21 days of study enrollment
- HAMA negative within 21 days prior to study enrollment
- Signed IRB approved consent form prior to any study-specific procedures being implemented
Who cannot join
- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment; a unilateral bone marrow biopsy was adequate; marrow core was greater than or equal to 2.0 cm in length
- Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for NHL within 28 days prior to study enrollment; subjects receiving low doses of steroids for non neoplastic disease acceptable to enter this study ("Low dose steroids" was defined as less than or equal to 10 mg of prednisone or equivalent per day.)
- Prior rituximab therapy within 120 days prior to study enrollment
- Prior radioimmunotherapy
- Prior splenectomy
- Splenomegaly defined as spleen mass greater than 700 grams, where splenic mass was defined as follows:
Show all 18Show fewer
- Spleen mass = л(X x Y x Z)/6 Where X and Y are the greatest perpendicular diameters in cm on any single CT scan slice, and Z is the number of CT scan slices upon which the spleen is visible times the slice thickness in cm
- Bulky disease as defined as any uni-dimensional measurement of lymphomatous mass exceeding 7 cm
- Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject had a generally accepted risk of recurrence less than 20%
- Central nervous system involvement by lymphoma
- Evidence of active infection requiring IV antibiotics at the time of study enrollment
- Known human immunodeficiency virus (HIV) infection
- New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
- Active obstructive hydronephrosis
- Evidence of clinically significant ascites or pleural effusion observed on screening physical examination or baseline CT scan
- Prior myeloablative therapy
- History of failed stem cell collection
- Pregnant or nursing subjects (Subjects of childbearing potential had to have a negative serum pregnancy test within 21 days of study enrollment. Males and females of childbearing age had to agree to use effective contraception for up to 12 months after the radioimmunotherapy.)
About this study
Official title: A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the post-treatment period, and for response and safety at 3,6,and 12 months during the first year, annually thereafter up to five years, and annually for additional safety and outcomes information up to 10 years.
- Conditions
- Lymphoma, Follicular
- Being tested
- Follicular Lymphoma
- Keywords
- Bexxar, tositumomab and iodine I 131 tositumomab therapeutic regiment, fission, Non-Hodgkin's lymphoma, Iodine I 131 Tositumomab, pharmacokinetics, tellurium
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicular LymphomaBiological
For subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's
| Study group | Role | What they receive |
|---|---|---|
| tositumomab and iodine I 131 tositumomab | Experimental | Subjects participating in this study will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I-131 tositumomab, immediately following an infusion of 450 mg of unlabeled tositumomab. Using the dosimetric data from three of the six imaging time points and the subject's weight, a patient-specific activity (mCi) of Iodine I-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). All subjects will then receive an infusion of unlabeled tositumomab (450 mg) immediately followed by an infusion of the subject specific dose of tellurium-derived Iodine I-131 tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Receives: Biological: Follicular Lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours
Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.
Measured: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)
Maximum Concentration (Cmax) Values
Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.
Measured: 0 to 7 days from dosimetric dose (given only once on Day 0)
Terminal Phase Half-life (t½)
The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.
Measured: 0 to 7 days from dosimetric dose (given only once on Day 0)
Clearance (CL) Values
Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.
Measured: 0 to 7 days from dosimetric dose given only once on Day 0
Volume of Distribution at Steady State (Vss)
Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.
Measured: 0 to 7 days from dosimetric dose given only once on Day 0
Secondary outcomes (11)
Area Under the Curve (AUC) at 0 to 120 Hours
Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.
Measured: 0-120 hours from dosimetric dose (given only once on Day 0)
Area Under the Curve (AUC) at 0 to 168 Hours
Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.
Measured: 0-168 h from dosimetric dose (given only once on Day 0)
Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)
Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.
Measured: 0 to infinity h from dosimetric dose (given only once on Day 0)
Maximum Concentration (Cmax) Values
Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.
Measured: 0 to 7 days from dosimetric dose (given only once on Day 0)
Mean Residence Times From Day 0 to Day 7
Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.
Measured: 0 to 7 days from dosimetric dose (given only once on Day 0)
Mean Absorbed Dose in the Source Organs and the Target Organs
The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.
Measured: 0 to 7 days from dosimetric dose
Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.
Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool
Measured: 0 to 7 days from dosimetric dose (given only once on Day 0)
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)
Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).
Measured: From Baseline up to 99 Months
Duration of Response
Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.
Measured: Week 7 to Week 260 post treatment
Progression-free Survival
Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.
Measured: Week 7 to Week 260 post treatment
Overall Survival
Time to death is defined as the time from the dosimetric dose to the date of death.
Measured: Week 7 to Week 260 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study start31 Mar 2003
- Primary completion4 Dec 2006
- Study completion30 Jun 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, FollicularStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00315731
- Sponsor's protocol ID
- 393229/027
- Status last verified
- Jun 2017
- First submitted
- 17 Apr 2006
- Last updated
- 11 Jul 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 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00315731
- Acronym / sponsor ID
- 393229/027
- Conditions
- Lymphoma, Follicular
- Keywords
- Bexxar, tositumomab and iodine I 131 tositumomab therapeutic regiment, fission, Non-Hodgkin's lymphoma, Iodine I 131 Tositumomab, pharmacokinetics, tellurium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2003 (actual)
- Primary completion
- 4 Dec 2006 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 19 Apr 2006 (estimated)
- Results
- Posted 23 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). Patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the post-treatment period, and for response and safety at 3,6,and 12 months during the first year, annually thereafter up to five years, and annually for additional safety and outcomes information up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tositumomab and iodine I 131 tositumomab | Experimental | Biological: Follicular LymphomaSubjects participating in this study will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I-131 tositumomab, immediately following an infusion of 450 mg of unlabeled tositumomab. Using the dosimetric data from three of the six imaging time points and the subject's weight, a patient-specific activity (mCi) of Iodine I-131 will be calculated to deliver the desired total body dose of radiation (75 cGy). All subjects will then receive an infusion of unlabeled tositumomab (450 mg) immediately followed by an infusion of the subject specific dose of tellurium-derived Iodine I-131 tositumomab (35 mg) to deliver a total body dose (TBD) of 75 cGy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- At least 18 years of age
- A histologically confirmed diagnosis of the following:
- Follicular lymphoma, Grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (World Health Organization/Revised European-American Lymphoma [WHO/REAL] classification).
- Follicular, small-cleaved; Follicular, mixed small-cleaved and large-cell; Follicular large-cell; or Transformed diffuse large-cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
- Stage III or IV disease at the time of study entry (based on Ann Arbor Staging Classification)
Key exclusion criteria (18 listed)
- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment; a unilateral bone marrow biopsy was adequate; marrow core was greater than or equal to 2.0 cm in length
- Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for NHL within 28 days prior to study enrollment; subjects receiving low doses of steroids for non neoplastic disease acceptable to enter this study ("Low dose steroids" was defined as less than or equal to 10 mg of prednisone or equivalent per day.)
- Prior rituximab therapy within 120 days prior to study enrollment
- Prior radioimmunotherapy
- Prior splenectomy
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 |
|---|---|---|
| Follicular LymphomaFor subjects with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's | Biological | tositumomab and iodine I 131 tositumomab |
Primary outcome
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours
Time frame: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)
Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.
Maximum Concentration (Cmax) Values
Time frame: 0 to 7 days from dosimetric dose (given only once on Day 0)
Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.
Terminal Phase Half-life (t½)
Time frame: 0 to 7 days from dosimetric dose (given only once on Day 0)
The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.
Clearance (CL) Values
Time frame: 0 to 7 days from dosimetric dose given only once on Day 0
Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.
Volume of Distribution at Steady State (Vss)
Time frame: 0 to 7 days from dosimetric dose given only once on Day 0
Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.
11 secondary outcomes
Area Under the Curve (AUC) at 0 to 120 Hours
Time frame: 0-120 hours from dosimetric dose (given only once on Day 0)
Area Under the Curve (AUC) at 0 to 168 Hours
Time frame: 0-168 h from dosimetric dose (given only once on Day 0)
Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)
Time frame: 0 to infinity h from dosimetric dose (given only once on Day 0)
Maximum Concentration (Cmax) Values
Time frame: 0 to 7 days from dosimetric dose (given only once on Day 0)
Mean Residence Times From Day 0 to Day 7
Time frame: 0 to 7 days from dosimetric dose (given only once on Day 0)
Mean Absorbed Dose in the Source Organs and the Target Organs
Time frame: 0 to 7 days from dosimetric dose
Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.
Time frame: 0 to 7 days from dosimetric dose (given only once on Day 0)
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)
Time frame: From Baseline up to 99 Months
Duration of Response
Time frame: Week 7 to Week 260 post treatment
Progression-free Survival
Time frame: Week 7 to Week 260 post treatment
Overall Survival
Time frame: Week 7 to Week 260 post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
- Results for study 393229/027 can be found on the GSK Clinical Study Register.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 1 study testing Follicular Lymphoma in people with Lymphoma, Follicular, 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 14 inclusion and 18 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 11 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Apr 2012). 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?
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours (time frame: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)). The study lists 5 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 11 Jul 2017.