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

Sponsor

Mallinckrodt (Industry)

Overall Status

Completed

CT.gov ID

NCT00054600

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Graft-versus-Host Disease	Drug: Methoxsalen Procedure: Extracorporeal Photopheresis	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Jun 1, 2002

Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611
2	University of Chicago	Chicago	Illinois	United States	60637
3	Tufts New England Medical Center	Boston	Massachusetts	United States	02111
4	Kansas City Cancer Center	Kansas City	Missouri	United States	64111
5	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
6	Texas Transplant	San Antonio	Texas	United States	78229
7	Royal Brisbane Hospital	Brisbane		Australia	4006
8	Peter MacCallum Cancer Institute	East Melbourne		Australia	8006
9	Alfred Hospital	Melbourne		Australia
10	Royal Melbourne Hospital	Parkville		Australia	3050
11	St. Vincent's Hospital	Sydney		Australia	2010
12	Hospital Azevedo Carvalho	Jau		Brazil
13	National Cancer Institute	Rio de Janeiro		Brazil
14	Hemocentro	Sao Paulo		Brazil
15	Ludwig-Maximiliano Universitaet Muenchen	Munchen		Germany	D-81377
16	Careggi Hospital	Florence		Italy	1-50134
17	San Martino Hospital	Genova		Italy	16132
18	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon		Portugal	1099-023
19	National Cancer Institute	Bratislava		Slovakia
20	Ankara University Medical School	Ankara		Turkey	6100
21	Hammersmith Hospital	London		United Kingdom	W12 0NN