Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168727
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2005-09-13
Brief Title:
Zevalin Followed by Rituxan Maintenance in Previously Treated Low Grade Non-Hodgkins Lymphoma
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Zevalin Ibritumomab Tiuxetan Followed by Rituxan Rituximab Maintenance in Previously Treated Low Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-08
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 determine the safety and effectiveness of a treatment regimen using Zevalin plus Rituxan for patients who have low grade Non-Hodgkins Lymphoma NHL or relapsed Non-Hodgkins lymphoma and have been previously treated This study will use an experimental scheduling regimen No chemotherapy will be used in this study
Detailed Description:
The objective of this study is to determine overall response rate event-free survival time-to-progression time-to-next-therapy and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter community-based setting as well as evaluate relative response rates in populations with and without prior rituximab therapy in first versus second relapse and with and without bulky 5 cm in greatest diameter disease
To meet the initial trial enrollment goal of 300 patients over two years 42 total sites were activated The study has subsequently closed to accrual Currently 8 sites remain active to follow the 12 subjects enrolled in the past year
To meet the initial trial enrollment goal of 300 patients over two years 42 total sites were activated The study has subsequently closed to accrual Currently 8 sites remain active to follow the 12 subjects enrolled in the past year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Former Biogen Idec 106-I001 | None | None | None |