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Protocol Summary for BEX104545

Protocol Summary
Protocol Id: BEX104545
Secondary Ids:
  • EAP CP-98-020
Title: Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
Phase: Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CBER
IND/IDE Number: 3323
IND/IDE Serial Number: unk
Has Expanded Access?:
Study Type: expanded access
Oversight Authority:
  • Switzerland: Federal Office of Public Health
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • United States: Food and Drug Administration
Collaborators:
  • N/A
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:
Record Verification Date: September 2009
Primary Outcomes:
Secondary Outcomes:
Conditions:
  • Lymphoma, Non-Hodgkin
Keywords:
  • Bexxar®
  • Iodine I 131 Tositumomab
  • relapsed low-grade non-Hodgkin's lymphoma
  • refractory low-grade non-Hodgkin's Lymphoma
  • expanded access study
  • EAP
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 years
Maximum Age: N/A
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official:
Overall Study Official Affiliation:
Overall Study Official Role:
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.