Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-Versus-Host Disease
Information source: Therakos
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft-Versus-Host Disease
Intervention: Methoxsalen (Drug); Extracorporeal Photopheresis (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Therakos
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).
Clinical Details
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
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
St. Vincent's Hospital, Sydney 2010, Australia
Royal Brisbane Hospital, Brisbane 4006, Australia
Royal Melbourne Hospital, Parkville 3050, Australia
Peter MacCallum Cancer Institute, East Melbourne 8006, Australia
Alfred Hospital, Melbourne, Australia
Hemocentro, Sao Paulo, Brazil
National Cancer Institute, Rio de Janeiro, Brazil
Hospital Azevedo Carvalho, Jau, Brazil
Ludwig-Maximiliano Universitaet Muenchen, Munchen D-81377, Germany
San Martino Hospital, Genova 16132, Italy
Careggi Hospital, Florence 1-50134, Italy
Instituto Portugues de Oncologia de Francisco Gentil, Lisbon 1099-023, Portugal
National Cancer Institute, Bratislava, Slovakia
Ankara University Medical School, Ankara 6100, Turkey
Hammersmith Hospital, London W12 0NN, United Kingdom
University of Florida, Gainesville, Florida, United States
University of Chicago, Chicago, Illinois 60637, United States
Tufts New England Medical Center, Boston, Massachusetts 02111, United States
Kansas City Cancer Center, Kansas City, Missouri 64111, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Texas Transplant, San Antonio, Texas 78229, United States
Additional Information
Related 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.
Starting date: June 2002
Ending date: June 2004
Last updated: June 23, 2005
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