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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00268203 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin's Lymphoma |
Biological: Iodine I 131 Tositumomab Therapeutic Regimen |
| Study Type: | Expanded Access |
| Official Title: | Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma |
| Study Start Date: | September 1998 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | BEX104545, EAP CP-98-020 |
| Study First Received: | December 20, 2005 |
| Last Updated: | July 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00268203 History of Changes |
| Health Authority: | Switzerland: Federal Office of Public Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
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Bexxar® Iodine I 131 Tositumomab relapsed low-grade non-Hodgkin's lymphoma |
refractory low-grade non-Hodgkin's Lymphoma expanded access study EAP |
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Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Iodine-131 anti-B1 antibody Trace Elements Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Anti-Infective Agents, Local Neoplasms Therapeutic Uses Iodine Micronutrients Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |