Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054613
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2003-02-05
Brief Title:
Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory Corticosteroid-Dependent or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
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 whether extracorporeal photoimmune therapy with UVADEX ECP added to standard therapy is effective in the treatment of chronic graft-versus-host disease GvHD
Detailed Description:
For patients who survive allogeneic bone marrow transplants greater than 100 days chronic GvHD is a major cause of non-relapse morbidity and mortality Depending on the presence of known associated risk factors chronic GvHD will occur in 20-50 of these transplant recipients with mortality rates varying from 20 to 70
Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD suppression of these cells by means other than medications could have benefit in the GvHD population
ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound UVADEX administered extracorporeally and ultraviolet A light After cells are reinfused into the patient their function is altered thereby activating mechanisms that allow for further regulation of specific lymphocyte populations
The purpose of this study is to determine whether ECP in conjunction with standard therapy is effective in the treatment of chronic GvHD Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor
Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD suppression of these cells by means other than medications could have benefit in the GvHD population
ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound UVADEX administered extracorporeally and ultraviolet A light After cells are reinfused into the patient their function is altered thereby activating mechanisms that allow for further regulation of specific lymphocyte populations
The purpose of this study is to determine whether ECP in conjunction with standard therapy is effective in the treatment of chronic GvHD Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor
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