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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00054600 |
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Date of registration:
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05/02/2003 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
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Scientific title:
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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 |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00054600 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Australia
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Brazil
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Germany
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Italy
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Portugal
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Slovakia
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Turkey
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Graft-Versus-Host Disease
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Intervention(s)
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Drug: Methoxsalen
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Procedure: Extracorporeal Photopheresis
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Secondary ID(s)
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GvHD Prevention
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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