Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062894
Status:
COMPLETED
Last Update Posted:
2007-09-17
First Post:
2003-06-17
Brief Title:
Study of Untreated or Transformed Follicular Non-Hodgkins Lymphoma With Fission-Derived Iodine I 131 Tositumomab
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-Center Study to Examine the Pharmacokinetics Whole Body and Organ Dosimetry and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkins lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab
Detailed Description:
This is a multi-center study in which 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkins lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of tellurium-derived Iodine I 131 Tositumomab Blood Pharmacokinetics total body clearance tumor and organ dosimetry and biodistribution will be assessed following administration of the dosimetric dose
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