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

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

Sponsoren

Hauptsponsor: Mallinckrodt

Quelle Mallinckrodt
Kurze Zusammenfassung

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).

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum June 2002
Fertigstellungstermin June 2004
Phase Phase 2
Studientyp Interventional
Einschreibung 60
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Methoxsalen

Interventionsart: Procedure

Interventionsname: Extracorporeal Photopheresis

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 60 Years

Gesunde Freiwillige: No

Ort
Einrichtung:
University of Florida | Gainesville, Florida, 32611, 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
Royal Brisbane Hospital | Brisbane, 4006, Australia
Peter MacCallum Cancer Institute | East Melbourne, 8006, Australia
Alfred Hospital | Melbourne, Australia
Royal Melbourne Hospital | Parkville, 3050, Australia
St. Vincent's Hospital | Sydney, 2010, Australia
Hospital Azevedo Carvalho | Jau, Brazil
National Cancer Institute | Rio de Janeiro, Brazil
Hemocentro | Sao Paulo, Brazil
Ludwig-Maximiliano Universitaet Muenchen | Munchen, D-81377, Germany
Careggi Hospital | Florence, 1-50134, Italy
San Martino Hospital | Genova, 16132, 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
Standort Länder

Australia

Brazil

Germany

Italy

Portugal

Slovakia

Turkey

United Kingdom

United States

Überprüfungsdatum

August 2017

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Prevention

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov