Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022685
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-08-10
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 III Clinical Trial of Immunotherapy With Humanized LL2 IgG Epratuzumab in Patients With Low-Grade Follicular B-Cell Non-Hodgkins Lymphoma Refractory to Rituxan Rituximab
Status:
UNKNOWN
Status Verified Date:
2003-04
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 Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkins lymphoma that has not responded to chemotherapy or rituximab
PURPOSE Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkins lymphoma that has not responded to chemotherapy or rituximab
Detailed Description:
OBJECTIVES
Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkins lymphoma
Confirm the convenient administration of this drug in this patient population
Determine the efficacy of this drug in terms of objective response rate in these patients
Determine the duration of response and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive epratuzumab IV over 15-60 minutes on days 1 8 15 and 22
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years
PROJECTED ACCRUAL Approximately 30-100 patients will be accrued for this study
Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkins lymphoma
Confirm the convenient administration of this drug in this patient population
Determine the efficacy of this drug in terms of objective response rate in these patients
Determine the duration of response and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive epratuzumab IV over 15-60 minutes on days 1 8 15 and 22
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years
PROJECTED ACCRUAL Approximately 30-100 patients 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-G01-2004 | None | None | None |
| UCLA-0009041 | None | None | None |
| IM-T-hLL2-07 | None | None | None |
| UCLA-BB-IND-7124 | None | None | None |