Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054600
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2003-02-05
Brief Title:
Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Study of Extracorporeal Photopheresis With UVADEX in the Setting of a Standard Myeloablative Conditioning Regimen for the Prevention of Graft-versus-Host Disease in Patients Undergoing an Allogeneic Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant
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 Photopheresis with UVADEX ECP prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease GvHD
Detailed Description:
Approximately 30 of HLA-identical related bone marrow graft recipients and up to 90 of patients receiving bone marrow from unrelated donors develop significant acute GvHD despite the use of prophylactic therapies such as cyclosporine and methotrexate About half of these patients respond to initial treatment with steroids and require no further treatment The remainder of these patients are either unresponsive to initial therapy or become steroid-resistant over time The prognosis in these cases is poor and mortality for patients with steroid-resistant GvHD may be as high as 50
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 ECP has shown activity in several inflammatory and autoimmune diseases including scleroderma rheumatoid arthritis transplantation rejection acute and chronic GvHD
In a previous single-center open label single-arm study of 56 patients receiving ECP treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to bone marrow transplantation from matched or partially matched human donors the incidence of grade II-IV acute GvHD was less than 10 This is in contrast to an expected incidence of approximately 40
The purpose of this study is to determine the role of ECP administered pre-transplant in preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen
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 ECP has shown activity in several inflammatory and autoimmune diseases including scleroderma rheumatoid arthritis transplantation rejection acute and chronic GvHD
In a previous single-center open label single-arm study of 56 patients receiving ECP treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to bone marrow transplantation from matched or partially matched human donors the incidence of grade II-IV acute GvHD was less than 10 This is in contrast to an expected incidence of approximately 40
The purpose of this study is to determine the role of ECP administered pre-transplant in preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen
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