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

This study has been completed.
Sponsor:
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00054600
First received: February 5, 2003
Last updated: April 7, 2010
Last verified: April 2010

February 5, 2003
April 7, 2010
June 2002
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Complete list of historical versions of study NCT00054600 on ClinicalTrials.gov Archive Site
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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

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Graft-Versus-Host Disease
  • Drug: Methoxsalen
  • Procedure: Extracorporeal Photopheresis
Not Provided
Shlomchik WD, Couzens MS, Tang CB, McNiff J, Robert ME, Liu J, Shlomchik MJ, Emerson SG. Prevention of graft versus host disease by inactivation of host antigen-presenting cells. Science. 1999 Jul 16;285(5426):412-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2004
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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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Turkey,   Italy,   United States,   United Kingdom,   Brazil,   Portugal,   Germany,   Slovakia
 
NCT00054600
GvHD Prevention
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Therakos
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Therakos
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP