Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-Versus-Host Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 5, 2003
Last Updated Date	June 23, 2005
Start Date ^†	June 2002
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00054600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-Versus-Host Disease
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
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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Graft-Versus-Host Disease
Intervention ^†	Drug: Methoxsalen Procedure: Extracorporeal Photopheresis
Study Arms / Comparison Groups
Publications *	Shlomchik WD, Couzens MS, Tang CB, McNiff J, Robert ME, Liu J, Shlomchik MJ, Emerson SG. Prevention of graft versus host disease by inactivation of host antigen-presenting cells. Science. 1999 Jul 16;285(5426):412-5.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	60
Completion Date	June 2004
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Patients with a diagnosis of a malignancy of the blood (e.g. leukemia) for which allogeneic bone marrow or peripheral blood stem cell transplantation is a treatment option. Patients who are candidates for a standard allogenic bone marrow transplant or PBSC transplant. Patients must have adequate renal, hepatic, pulmonary and cardiac function to enable the patient to tolerate shifts in the volumes of body fluids associated with extracorporeal photopheresis, as determined by the physician's clinical judgement. Patients must weigh at least 40 kg (88 lbs) Exclusion Criteria: Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Australia, Brazil, Germany, Italy, Portugal, Slovakia, Turkey, United Kingdom
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00054600
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Therakos
Collaborators ^††
Investigators ^†
Information Provided By	Therakos
Verification Date	June 2004
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.