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Sponsored by: |
Therakos |
---|---|
Information provided by: | Therakos |
ClinicalTrials.gov Identifier: | NCT00054600 |
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).
Condition | Intervention | Phase |
---|---|---|
Graft-Versus-Host Disease |
Drug: Methoxsalen Procedure: Extracorporeal Photopheresis |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | June 2004 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Tufts New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Missouri | |
Kansas City Cancer Center | |
Kansas City, Missouri, United States, 64111 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
Texas Transplant | |
San Antonio, Texas, United States, 78229 | |
Australia | |
St. Vincent's Hospital | |
Sydney, Australia, 2010 | |
Royal Brisbane Hospital | |
Brisbane, Australia, 4006 | |
Royal Melbourne Hospital | |
Parkville, Australia, 3050 | |
Peter MacCallum Cancer Institute | |
East Melbourne, Australia, 8006 | |
Alfred Hospital | |
Melbourne, Australia | |
Brazil | |
Hemocentro | |
Sao Paulo, Brazil | |
National Cancer Institute | |
Rio de Janeiro, Brazil | |
Hospital Azevedo Carvalho | |
Jau, Brazil | |
Germany | |
Ludwig-Maximiliano Universitaet Muenchen | |
Munchen, Germany, D-81377 | |
Italy | |
San Martino Hospital | |
Genova, Italy, 16132 | |
Careggi Hospital | |
Florence, Italy, 1-50134 | |
Portugal | |
Instituto Portugues de Oncologia de Francisco Gentil | |
Lisbon, Portugal, 1099-023 | |
Slovakia | |
National Cancer Institute | |
Bratislava, Slovakia | |
Turkey | |
Ankara University Medical School | |
Ankara, Turkey, 6100 | |
United Kingdom | |
Hammersmith Hospital | |
London, United Kingdom, W12 0NN |
Study ID Numbers: | GvHD Prevention |
Study First Received: | February 5, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00054600 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Extracorporeal Photopheresis Graft-versus-Host Disease |
Graft Versus Host Disease Photosensitizing Agents Radiation-Sensitizing Agents |
Methoxsalen Graft vs Host Disease Homologous Wasting Disease |
Photosensitizing Agents Radiation-Sensitizing Agents Immune System Diseases Methoxsalen Therapeutic Uses |
Physiological Effects of Drugs Graft vs Host Disease Dermatologic Agents Pharmacologic Actions |