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

Chronic Graft Versus Host Disease Clinical Trial

Official title:

A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380535
• Other study ID #: 10-005
• Secondary ID: 2010-022780-35
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2011
• Est. completion date: March 2015

Study information

• Verified date: February 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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).

Exclusion Criteria:

• 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:

1. safety and well-being of participant or offspring

2. safety of study staff

3. analysis of results

Related Conditions & MeSH terms

• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Austria	General Hospital of Vienna (Medical University of Vienna)	Vienna
France	CHU de Nantes	Nantes
France	Hospital Saint Louis	Paris
France	Hopital Saint Antoine	Saint Antoine	Paris
Germany	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	Munchen
Germany	Uniklinik für Kinder und Jugendmedizin	Tubingen
Hungary	Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,	Budapest
Italy	A.O.U. Policlinico- Vittorio Emanuele	Catania
Italy	Universita de Genova - Ospedale S. Martino	Genova
Spain	Santa Creu I Sant Pau	Barcelona
Spain	Hospital Marques de Valdecilla	Santander	Cantabria
United Kingdom	University of Birmingham: Queen Elizabeth Hospital	Birmingham
United Kingdom	Kings College Hospital	London	Greater London
United Kingdom	Royal Marsden Hospital	London
United States	Medical City Dallas Hospital,Transplant center	Dallas	Texas
United States	Parkland Memorial Hospital	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana Blood and Marrow Transplantation Research	Indianapolis	Indiana
United States	University of Miami Hospital	Miami	Florida
United States	Vanderbilt Ingram Cancer Center	Nashville	Tennessee
United States	Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,	New Orleans	Louisiana
United States	New York Presbyterian Hospital	New York	New York
United States	Methodist healthcare system of san Antonio	San Antonio	Texas
United States	Stony brook university medical Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mallinckrodt	Parexel

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Hungary,  Italy,  Spain,  United Kingdom, 

References & Publications (1)

Jagasia M, Scheid C, Socié G, Ayuk FA, Tischer J, Donato ML, Bátai Á, Chen H, Chen SC, Chin T, Boodée 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Overall Response at Week 28	Participants with overall response included those with partial response or complete response, according to study staff who did not know which treatment they received (blinded assessment).	Week 28

External Links

•   Cited article made available by the US National Library of Medicine, National Institutes of Health