Graft-versus-Host DiseasePhase 2NCT00054600
Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
A Phase 2 study testing Methoxsalen and Extracorporeal Photopheresis in people with Graft-versus-Host Disease, run by Mallinckrodt at 21 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft-versus-Host Disease
- What is being tested?
- Methoxsalen and Extracorporeal Photopheresis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 21 sitesin 9 countries
- Study dates
- Jun 2002to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
United States6 sites
Tufts New England Medical Center
Boston, Massachusetts, 02111
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Florida
Gainesville, Florida, 32611
Kansas City Cancer Center
Kansas City, Missouri, 64111
Texas Transplant
San Antonio, Texas, 78229
Australia5 sites
Royal Brisbane Hospital
Brisbane, 4006
Peter MacCallum Cancer Institute
East Melbourne, 8006
Alfred Hospital
Melbourne
Royal Melbourne Hospital
Parkville, 3050
St. Vincent's Hospital
Sydney, 2010
Brazil3 sites
Hospital Azevedo Carvalho
Jaú
National Cancer Institute
Rio de Janeiro
Hemocentro
São Paulo
Italy2 sites
Careggi Hospital
Florence, 1-50134
San Martino Hospital
Genova, 16132
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1099-023
About this study
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
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).
Read the 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.
- Conditions
- Graft-versus-Host Disease
- Being tested
- Methoxsalen, Extracorporeal Photopheresis
- Keywords
- Extracorporeal Photopheresis, Graft-versus-Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxsalenDrug
Extracorporeal PhotopheresisProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startJun 2002
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054600
- Sponsor's protocol ID
- GvHD Prevention
- Status last verified
- Aug 2017
- First submitted
- 5 Feb 2003
- Last updated
- 16 Aug 2017
- Results posted
- No
Publications
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. doi: 10.1126/science.285.5426.412.
PubMed 10411505
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00054600
- Acronym / sponsor ID
- GvHD Prevention
- Conditions
- Graft-versus-Host Disease
- Keywords
- Extracorporeal Photopheresis, Graft-versus-Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Jun 2004
- First posted
- 6 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxsalen | Drug | – |
| Extracorporeal Photopheresis | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Background: PubMed 10411505Shlomchik 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. doi: 10.1126/science.285.5426.412.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methoxsalen and Extracorporeal Photopheresis in people with Graft-versus-Host Disease, run by Mallinckrodt at 21 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia, Brazil, Italy, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00054600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.