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

Phase 2

Completed

• Conditions: Graft-versus-Host Disease

• Registration Number: NCT00054600
• Lead Sponsor: Mallinckrodt

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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Study Completion: 2004-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (20)

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

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