Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042913
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2002-08-05
Brief Title:
Epratuzumab in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Open Label Randomized Dose And Schedule Finding Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2003-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with diffuse large B-cell non-Hodgkins lymphoma treated with epratuzumab
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks
Arm II Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks
Arm III Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 150 patients 50 per treatment arm will be accrued for this study
Determine the response rate of patients with diffuse large B-cell non-Hodgkins lymphoma treated with epratuzumab
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks
Arm II Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks
Arm III Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 150 patients 50 per treatment arm will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2094 | None | None | None |
| UCLA-0201056 | None | None | None |
| AMGEN-AMG-412-159 | None | None | None |