Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240578
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2005-10-14
Brief Title:
Patients With Low-Grade Non-Hodgkins Lymphoma Previously Treated With Iodine I 131 Tositumomab
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKINS LYMPHOMA PREVIOUSLY TREATED WITH IODINE I 131 TOSITUMOMAB IN STUDIES CP-97-011 CP-98-025 CP-99-032 or CP-99-036
Status:
COMPLETED
Status Verified Date:
2016-01
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:
This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab BEXXAR on Studies CP-97-011 CP-98-025 CP-99-032 or CP-99-036 All patients will be assessed for survival and disease status including subsequent therapy for NHL and for long-term safety Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell CBC count with a differential and platelet count will be obtained annually Additionally patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression
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