Clinical trial NCT00054600: Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft-versus-Host Disease
Keywords: Extracorporeal Photopheresis
Graft-versus-Host Disease
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2003-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: San Antonio
country: United States
facility: Texas Transplant
state: Texas
city: Brisbane
country: Australia
facility: Royal Brisbane Hospital
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Sydney
country: Australia
facility: St. Vincent's Hospital
city: Jau
country: Brazil
facility: Hospital Azevedo Carvalho
city: Rio de Janeiro
country: Brazil
facility: National Cancer Institute
city: Sao Paulo
country: Brazil
facility: Hemocentro
city: Munchen
country: Germany
facility: Ludwig-Maximiliano Universitaet Muenchen
city: Florence
country: Italy
facility: Careggi Hospital
city: Genova
country: Italy
facility: San Martino Hospital
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil
city: Bratislava
country: Slovakia
facility: National Cancer Institute
city: Ankara
country: Turkey
facility: Ankara University Medical School
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
References:
citation: 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. doi: 10.1126/science.285.5426.412.