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

August 14, 2017 updated by: Mallinckrodt

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4006
        • Royal Brisbane Hospital
      • East Melbourne, Australia, 8006
        • Peter Maccallum Cancer Institute
      • Melbourne, Australia
        • Alfred Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
      • Sydney, Australia, 2010
        • St. Vincent's Hospital
  • Brazil
      • Jau, Brazil
        • Hospital Azevedo Carvalho
      • Rio de Janeiro, Brazil
        • National Cancer Institute
      • Sao Paulo, Brazil
        • Hemocentro
  • Germany
      • Munchen, Germany, D-81377
        • Ludwig-Maximiliano Universitaet Muenchen
  • Italy
      • Florence, Italy, 1-50134
        • Careggi Hospital
      • Genova, Italy, 16132
        • San Martino Hospital
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Instituto Portugues de Oncologia de Francisco Gentil
  • Slovakia
      • Bratislava, Slovakia
        • National Cancer Institute
  • Turkey
      • Ankara, Turkey, 6100
        • Ankara University Medical School
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Hammersmith Hospital
  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts New England Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Texas
      • San Antonio, Texas, United States, 78229
        • Texas Transplant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GvHD Prevention

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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