Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
NCT ID: NCT01380535
Last Updated: 2020-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2011-11-30
2015-03-31
Brief Summary
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Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.
This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.
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Detailed Description
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This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment.
Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ECP Methoxsalen + Standard of Care
Participants receive methoxsalen administered via ECP in addition to standard of care
ECP Methoxsalen
Methoxsalen delivered by ECP
Standard of Care
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Standard of Care
Participants receive standard of care only
Standard of Care
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Interventions
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ECP Methoxsalen
Methoxsalen delivered by ECP
Standard of Care
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Received certain treatments during time periods disallowed by protocol
* Has infections and/or requires treatment that (per protocol or in the opinion of the investigator) might compromise:
1. safety and well-being of participant or offspring
2. safety of study staff
3. analysis of results
18 Years
99 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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University of Miami Hospital
Miami, Florida, United States
Indiana Blood and Marrow Transplantation Research
Indianapolis, Indiana, United States
Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,
New Orleans, Louisiana, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
Stony brook university medical Center
Stony Brook, New York, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Medical City Dallas Hospital,Transplant center
Dallas, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
Methodist healthcare system of san Antonio
San Antonio, Texas, United States
General Hospital of Vienna (Medical University of Vienna)
Vienna, , Austria
Hopital Saint Antoine
Saint-Antoine, Paris, France
CHU de Nantes
Nantes, , France
Hospital Saint Louis
Paris, , France
Universitätsklinik Köln
Cologne, , Germany
Universitäts-Klinikum Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitatskrankenhaus Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Universitätklinikum Mannheim
Mannheim, , Germany
Medizinische Universitatsklinik
München, , Germany
Uniklinik für Kinder und Jugendmedizin
Tübingen, , Germany
Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,
Budapest, , Hungary
A.O.U. Policlinico- Vittorio Emanuele
Catania, , Italy
Universita de Genova - Ospedale S. Martino
Genova, , Italy
Hospital Marques de Valdecilla
Santander, Cantabria, Spain
Santa Creu I Sant Pau
Barcelona, , Spain
Kings College Hospital
London, Greater London, United Kingdom
University of Birmingham: Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Countries
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References
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Jagasia M, Scheid C, Socie G, Ayuk FA, Tischer J, Donato ML, Batai A, Chen H, Chen SC, Chin T, Boodee H, Mitri G, Greinix HT. Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv. 2019 Jul 23;3(14):2218-2229. doi: 10.1182/bloodadvances.2019000145.
Related Links
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Cited article made available by the US National Library of Medicine, National Institutes of Health
Other Identifiers
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2010-022780-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
10-005
Identifier Type: -
Identifier Source: org_study_id
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