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

Completed · Phase 2

Conditions studied: Graft-versus-Host Disease

In brief

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).

Key facts

Study ID

NCT00054600

Run by

Mallinckrodt

People needed

60

Starts

2002-06-01

Expected to finish

2004-06-01

Last updated by the study team

2017-08-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Kansas City Cancer Center — Kansas City, Missouri, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Texas Transplant — San Antonio, Texas, United States
• 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, Australia
• Hospital Azevedo Carvalho — Jaú, Brazil
• National Cancer Institute — Rio de Janeiro, Brazil
• Hemocentro — São Paulo, Brazil
• Ludwig-Maximiliano Universitaet Muenchen — München, Germany
• Careggi Hospital — Florence, Italy
• San Martino Hospital — Genova, Italy
• Instituto Portugues de Oncologia de Francisco Gentil — Lisbon, Portugal
• National Cancer Institute — Bratislava, Slovakia
• Ankara University Medical School — Ankara, Turkey (Türkiye)
• Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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