Graft-versus-Host DiseasePhase 2NCT00054613
Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
A Phase 2 study testing Methoxsalen and Extracorporeal Photopheresis in people with Graft-versus-Host Disease, run by Mallinckrodt at 31 sites in 12 countries.
Trial summary
The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD). Read more about this study
- Who is it for?
- Any age
- 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
- 72 participants
- Where
- 31 sitesin 12 countries
- Study dates
- Jun 2002to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
- Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
- Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
- Patients must weight at least 40 kg (88 lbs.)
Who cannot join
- Active gastrointestinal bleeding
- Previous treatment with ECP
- Females who are pregnant and/or lactating
Trial locations and contacts
31 sites in 12 countries.
31 sites in 12 countries
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109-0914
Tufts New England Medical Center
Boston, Massachusetts, 02111
Brigham and Womens
Boston, Massachusetts, 02115
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Jewish Hospital
Cincinnati, Ohio, 45236
University of Florida
Gainesville, Florida, 32610
Kansas City Cancer Center
Kansas City, Missouri, 64111
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Nebraska
Omaha, Nebraska, 68198-7680
Fred Hutchinson Cancer Research Center
Seattle, Washington, 19024
Australia4 sites
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Peter MacCallum
East Melbourne
Alfred Hospital
Melbourne
Royal Melbourne Hospital
Parkville, 3050
Germany4 sites
University of Dresden
Dresden, D-01307
Universitatis Hautklinik
Essen, 45122
Universitatsklinikum Leipzig AOR
Leipzig, D-04103
Ludwig-Maximilians-Universitaet Muenchen
München, D-81377
France2 sites
Hopital Edouard Herriot
Lyon, 69437
Hopital Pitie-Salpetriere
Paris, F-75013
Italy2 sites
Careggi Hospital
Florence, 1-50134
San Martino Hospital
Genova, 16132
United Kingdom2 sites
Glasgow Royal Infirmary
Glasgow, G4 OS4
Rotherham General Hospital
Rotherham, Yorkshire, S60 2UD
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, 1099-023
Spain1 site
Hospital dela Santa Creu i Sant Pau. Universitat Autonoma de Barcelona
Barcelona, E-08025
Turkey (Türkiye)1 site
Ankara University Medical School
Altındağ, Ankara, 6100
About this study
Official title: A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).
Read the detailed description
For patients who survive allogeneic bone marrow transplants greater than 100 days, chronic GvHD is a major cause of non-relapse morbidity and mortality. Depending on the presence of known associated risk factors, chronic GvHD will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%.
Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD, suppression of these cells by means other than medications could have benefit in the GvHD population.
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.
The purpose of this study is to determine whether ECP, in conjunction with standard therapy, is effective in the treatment of chronic GvHD. Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.
- Conditions
- Graft-versus-Host Disease
- Being tested
- Methoxsalen, Extracorporeal Photopheresis
- Keywords
- Graft-versus-Host Disease, Extracorporeal Photopheresis
- 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 completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054613
- Sponsor's protocol ID
- GvHD-SK1
- Status last verified
- Aug 2017
- First submitted
- 5 Feb 2003
- Last updated
- 16 Aug 2017
- Results posted
- No
Publications
Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37. doi: 10.1016/s1083-8791(98)90007-6.
PubMed 9701389Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. doi: 10.3109/10428190009148389.
PubMed 10784386Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11.
PubMed 18621929
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 Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT00054613
- Acronym / sponsor ID
- GvHD-SK1
- Conditions
- Graft-versus-Host Disease
- Keywords
- Graft-versus-Host Disease, Extracorporeal Photopheresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Mar 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 photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).
Detailed description
For patients who survive allogeneic bone marrow transplants greater than 100 days, chronic GvHD is a major cause of non-relapse morbidity and mortality. Depending on the presence of known associated risk factors, chronic GvHD will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%.
Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD, suppression of these cells by means other than medications could have benefit in the GvHD population.
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.
The purpose of this study is to determine whether ECP, in conjunction with standard therapy, is effective in the treatment of chronic GvHD. Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
- Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
- Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
- Patients must weight at least 40 kg (88 lbs.)
Key exclusion criteria (3 listed)
- Active gastrointestinal bleeding
- Previous treatment with ECP
- Females who are pregnant and/or lactating
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 9701389Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37. doi: 10.1016/s1083-8791(98)90007-6.
- Background: PubMed 10784386Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. doi: 10.3109/10428190009148389.
- Derived from this study: PubMed 18621929Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. doi: 10.1182/blood-2008-03-141481. Epub 2008 Jul 11.
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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.
31 sites in 12 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 31 sites in 12 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 3 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 31 sites in United States, Australia, Germany, France, Italy and 7 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 NCT00054613, which also lists 3 linked publications.
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.