Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268203
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2005-12-20
Brief Title:
Expanded Access Study Of BEXXAR For Low Grade And Transformed Low-Grade Non-Hodgkins Lymphoma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Expanded Access Study of Iodine I 131 Tositumomab for RelapsedRefractory Low-Grade and Transformed Low-Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-Hodgkins 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None