Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT00022906
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
Study Overview
Official Title:
Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients With Previously Treated Non-Hodgkin's 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-Hodgkin's 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: