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Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease Clinical research trials and Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease. Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease  Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease
Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease
For Condition: Graft-Versus-Host Disease
Status: Recruiting
Sponsor(s): Therakos ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Careggi Hospital *Not yet recruiting*
Florence, , 1-50134
Italy
Not yet recruiting
St. Vincent's Hospital *Not yet recruiting*
Sydney, , 2010
Australia
Not yet recruiting
Royal Melbourne Hospital *Not yet recruiting*
Parkville, , 3050
Australia
Not yet recruiting
Royal Brisbane Hospital *Not yet recruiting*
Brisbane, , 4006
Australia
Not yet recruiting
Hammersmith Hospital *Not yet recruiting*
London, , W12 0NN
United Kingdom
Not yet recruiting Jane Apperley 011-44-208-383-3237
Instituto Portugues de Oncologia de Francisco Gentil *Not yet recruiting*
Lisbon, , 1099-023
Portugal
Not yet recruiting Alexandra Machado 351-21-722-9864
Hospital Azevedo Carvalho *Not yet recruiting*
Jau, ,
Brazil
Not yet recruiting
Ankara University Medical School *Not yet recruiting*
Ankara, , 6100
Turkey
Not yet recruiting
Kansas City Cancer Center *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Sunil Abhyankar 816-531-1417
San Martino Hospital *Not yet recruiting*
Genova, , 16132
Italy
Not yet recruiting Stefania Bregante 390105553405
National Cancer Institute *Not yet recruiting*
Rio de Janeiro, ,
Brazil
Not yet recruiting
University of Florida *Recruiting*
Gainesville, Florida,
United States
Recruiting
Hemocentro *Not yet recruiting*
Sao Paulo, ,
Brazil
Not yet recruiting
Alfred Hospital *Not yet recruiting*
Melbourne, ,
Australia
Not yet recruiting
Texas Transplant *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Paul Shaughnessy 210-575-8500
University of Chicago *Not yet recruiting*
Chicago, Illinois, 60637
United States
Not yet recruiting
Peter MacCallum Cancer Institute *Not yet recruiting*
East Melbourne, , 8006
Australia
Not yet recruiting
National Cancer Institute *Not yet recruiting*
Bratislava, ,
Slovakia
Not yet recruiting
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Julie Curtis 216-444-9384
Ludwig-Maximiliano Universitaet Muenchen *Not yet recruiting*
Munchen, , D-81377
Germany
Not yet recruiting
Tufts New England Medical Center *Not yet recruiting*
Boston, Massachusetts, 02111
United States
Not yet recruiting Tracy Bell 617-636-5558
Additional Information:
Study ID Numbers: GvHD Prevention;
Study Start Date: June 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054600
Other Graft-Versus-Host Disease Studies:
1. Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
2. Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease
Related Studies:
Other Graft-Versus-Host Disease Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Safety and Efficacy Study of Photopheresis with UVADEX to Prevent Graft-versus-Host Disease
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