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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

Page last updated: June 20, 2008

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