Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

Completed · Early Phase 1

Conditions studied: Chronic Graft Versus Host Disease

In brief

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. 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.

Key facts

Study ID

NCT01380535

Run by

Mallinckrodt

People needed

60

Starts

2011-11-01

Expected to finish

2015-03-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for inclusion in this trial, the patient must have moderate to severe chronic graft-versus-host disease [defined by the National Institutes of Health (NIH) 2015 Consensus Criteria] that started within 3 years after hematopoietic stem cell transplantation (HSCT).

You may not qualify if…

• Is intolerant to corticosteroids or hypersensitive to methoxsalen
• 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:
• safety and well-being of participant or offspring
• safety of study staff
• analysis of results

Where it is running

• 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

Full record on ClinicalTrials.gov

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