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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 20, 2005 |
| Last Updated Date | July 16, 2009 |
| Start Date ICMJE | September 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
Total number of patients successfully treated with Bexxar®. |
| Change History | Complete list of historical versions of study NCT00268203 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
Demographics,dosing,laboratory data,all adverse events(AEs),all possibly or probably related AEs,all serious adverse events (SAEs),all possibly or probably related SAEs,response rate and duration, time to progression,and deaths will be summarized. |
| Descriptive Information | |
| Brief Title ICMJE | Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma |
| Official Title ICMJE | Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma |
| Brief 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. 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Expanded Access |
| Study Design ICMJE | |
| Condition ICMJE | Non-Hodgkin's Lymphoma |
| Intervention ICMJE | Biological: Iodine I 131 Tositumomab Therapeutic Regimen |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | No longer available |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00268203 |
| Responsible Party | Study Director, GSK |
| Study ID Numbers ICMJE | BEX104545, EAP CP-98-020 |
| Study Sponsor ICMJE | GlaxoSmithKline |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | GlaxoSmithKline |
| Verification Date | July 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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