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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Methoxsalen

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.