Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022880
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-08-15
Brief Title:
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
A Phase I Dose-Escalation Open-Label Multicenter Study of Iodine-131 Anti-B1 Antibody for Intermediate- and High-Risk B-Cell Chronic Lymphocytic Leukemia
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 test the safety of Iodine-131 Anti-B1 Antibody to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects
Detailed Description:
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti-B1 Antibody in patients with CLL 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 35cGy for patients with platelet counts 100000 cellsmm3 Cohort A and increased by groups in 10cGy increments until the maximum tolerated dose MTD is reached Subsequently patients with platelet counts from 75000-100000 cellsmm3 Cohort B will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD
The dose escalation will be started at 35cGy for patients with platelet counts 100000 cellsmm3 Cohort A and increased by groups in 10cGy increments until the maximum tolerated dose MTD is reached Subsequently patients with platelet counts from 75000-100000 cellsmm3 Cohort B will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD
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