Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022906
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-08-15
Brief Title:
Safety and Efficacy of Iodine-131 Anti-B1 Antibody for NHL Patients With Greater Than 25 Bone Marrow Involvement
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
Phase I Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients With Previously Treated Non-Hodgkins Lymphoma With More Than 25 Bone Marrow Involvement
Status:
UNKNOWN
Status Verified Date:
2004-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to determine the proper dose effectiveness and safety of using Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated non-Hodgkins lymphoma NHL who have greater than 25 bone marrow involvement with lymphoma
Detailed Description:
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25 bone marrow involvement with lymphoma Secondary endpoints include assessment of response rate duration of response relapse-free survival time to treatment failure safety and survival
The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until the maximum tolerated dose in reached
The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until the maximum tolerated dose in reached
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