Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease

Graft-versus-Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054600
• Other study ID #: GvHD Prevention
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: August 14, 2017
• Start date: June 2002
• Est. completion date: June 2004

Study information

• Verified date: August 2017
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-Host Disease

Intervention

Drug:
• Methoxsalen

Procedure:
• Extracorporeal Photopheresis

Locations

Country	Name	City	State
Australia	Royal Brisbane Hospital	Brisbane
Australia	Peter MacCallum Cancer Institute	East Melbourne
Australia	Alfred Hospital	Melbourne
Australia	Royal Melbourne Hospital	Parkville
Australia	St. Vincent's Hospital	Sydney
Brazil	Hospital Azevedo Carvalho	Jau
Brazil	National Cancer Institute	Rio de Janeiro
Brazil	Hemocentro	Sao Paulo
Germany	Ludwig-Maximiliano Universitaet Muenchen	Munchen
Italy	Careggi Hospital	Florence
Italy	San Martino Hospital	Genova
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Slovakia	National Cancer Institute	Bratislava
Turkey	Ankara University Medical School	Ankara
United Kingdom	Hammersmith Hospital	London
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	Kansas City Cancer Center	Kansas City	Missouri
United States	Texas Transplant	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Germany,  Italy,  Portugal,  Slovakia,  Turkey,  United Kingdom, 

References & Publications (1)

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. — View Citation