Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017641
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-06-06
Brief Title:
Phase I Study of Immune Ablation and CD34 Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
Sponsor:
Northwestern Memorial Hospital
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-11
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:
OBJECTIVES
I Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus
I Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus
Detailed Description:
PROTOCOL OUTLINE Patients receive cyclophosphamide IV over 1 hour for 2 doses Patients receive filgrastim G-CSF subcutaneously SC beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete Leukapheresis continues daily until target number of cells is harvested CD 34 cells are isolated from peripheral blood stem cells PBSC in vitro
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2 anti-thymocyte globulin IV over 10 hours on days -4 to -2 and G-CSF SC beginning on day 0 and continuing until blood counts recover Patients undergo reinfusion of CD34 PBSC on day 0
Patients are followed weekly for 90 days monthly for 1 year and at 2 years
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2 anti-thymocyte globulin IV over 10 hours on days -4 to -2 and G-CSF SC beginning on day 0 and continuing until blood counts recover Patients undergo reinfusion of CD34 PBSC on day 0
Patients are followed weekly for 90 days monthly for 1 year and at 2 years
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 |
|---|---|---|---|
| NU-95LU1 | None | None | None |