Last updated: 11/07/2018 07:59:19
Post-marketing observational retrospective study of patients who received the dosimetric dose of the BEXXAR® therapeutic regimen (tositumomab and iodine I 131 tositumomab) in the commercial setting: assessment of altered biodistribution
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Post-marketing observational retrospective study of patients who received the dosimetric dose of the BEXXAR® therapeutic regimen (tositumomab and iodine I 131 tositumomab) in the commercial setting: assessment of altered biodistribution
Trial description: The BEXXAR US Prescribing Information requires that the biodistribution of iodine I 131 tositumomab be assessed after the dosimetric dose by both determination of total body residence time and visual inspection of gamma camera images. The therapeutic dose is not administered if either method indicates an altered biodistribution.The objectives of this study are as follows: To determine the frequency of patients with an altered biodistribution of iodine I-131 tositumomab after receiving the dosimetric dose in the post-marketing setting from 27 June 2003 to 26 February 2010.To evaluate the utility and clinical benefit of visual assessment of gamma camera images, obtained after the dosimetric dose, for determining whether to administer the therapeutic dose.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The frequency of patients with an altered biodistribution of iodine I-131 tositumomab after receiving the dosimetric dose in the post-marketing setting.
Timeframe: 27 June 2003 to 26 February 2010
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Retrospective
Clinical publications:
Richard L. Wahl, Thierry J. Horner, Mark S. Kaminski, Thomas S. Lin. Observational Retrospective Study of Altered Biodistribution of Tositumomab and I-131 Tositumomab. J Nucl Med. 2015;56(11):1800-3.
Medical condition
Lymphoma, Non-Hodgkin
Product
tositumomab
Collaborators
Not applicable
Study date(s)
June 2003 to February 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Inclusion Criteria:
- The incidence of altered biodistribution will be assessed retrospectively in patients who received either the dosimetric dose or the dosimetric and therapeutic doses of the BEXXAR therapeutic regimen in the post-marketing commercial setting.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- The incidence of altered biodistribution will be assessed retrospectively in patients who received either the dosimetric dose or the dosimetric and therapeutic doses of the BEXXAR therapeutic regimen in the post-marketing commercial setting.
- Independent review of biodistribution will only be conducted on cases of altered biodistribution.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-26-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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