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

Primary Purpose

Chronic Graft Versus Host Disease

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
ECP Methoxsalen
Standard of Care
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft Versus Host Disease focused on measuring Extracorporeal photopheresis therapy, Methoxsalen, cGVHD, hematopoietic stem cell transplantation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Hospital
  • Indiana Blood and Marrow Transplantation Research
  • Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,
  • Karmanos Cancer Institute
  • Hackensack University Medical Center
  • New York Presbyterian Hospital
  • Stony brook university medical Center
  • Vanderbilt Ingram Cancer Center
  • Medical City Dallas Hospital,Transplant center
  • Parkland Memorial Hospital
  • Methodist healthcare system of san Antonio
  • General Hospital of Vienna (Medical University of Vienna)
  • Hopital Saint Antoine
  • CHU de Nantes
  • Hospital Saint Louis
  • Universitätsklinik Köln
  • Universitäts-Klinikum Carl Gustav Carus
  • Universitatsklinikum Erlangen
  • Universitätsklinikum Essen
  • Universitatskrankenhaus Hamburg-Eppendorf
  • Universitätsklinikum Leipzig AöR
  • Universitätklinikum Mannheim
  • Medizinische Universitatsklinik
  • Uniklinik für Kinder und Jugendmedizin
  • Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,
  • A.O.U. Policlinico- Vittorio Emanuele
  • Universita de Genova - Ospedale S. Martino
  • Hospital Marques de Valdecilla
  • Santa Creu I Sant Pau
  • Kings College Hospital
  • University of Birmingham: Queen Elizabeth Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ECP Methoxsalen + Standard of Care

Standard of Care

Arm Description

Participants receive methoxsalen administered via ECP in addition to standard of care

Participants receive standard of care only

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 22, 2011
Last Updated
February 7, 2020
Sponsor
Mallinckrodt
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01380535
Brief Title
Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft Versus Host Disease
Keywords
Extracorporeal photopheresis therapy, Methoxsalen, cGVHD, hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Pilot Study for the 2015 NIH Consensus Criteria to inform the design of subsequent studies
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECP Methoxsalen + Standard of Care
Arm Type
Experimental
Arm Description
Participants receive methoxsalen administered via ECP in addition to standard of care
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants receive standard of care only
Intervention Type
Drug
Intervention Name(s)
ECP Methoxsalen
Other Intervention Name(s)
Uvadex, Extracorporeal photopheresis (ECP)
Intervention Description
Methoxsalen delivered by ECP
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Reference therapy
Intervention Description
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Primary Outcome Measure Information:
Title
Number of Participants With an Overall Response at Week 28
Description
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).
Time Frame
Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: safety and well-being of participant or offspring safety of study staff analysis of results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony brook university medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Medical City Dallas Hospital,Transplant center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Methodist healthcare system of san Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
General Hospital of Vienna (Medical University of Vienna)
City
Vienna
Country
Austria
Facility Name
Hopital Saint Antoine
City
Saint Antoine
State/Province
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Hospital Saint Louis
City
Paris
Country
France
Facility Name
Universitätsklinik Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitäts-Klinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01309
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitatskrankenhaus Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Medizinische Universitatsklinik
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Uniklinik für Kinder und Jugendmedizin
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
A.O.U. Policlinico- Vittorio Emanuele
City
Catania
Country
Italy
Facility Name
Universita de Genova - Ospedale S. Martino
City
Genova
Country
Italy
Facility Name
Hospital Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Kings College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University of Birmingham: Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31332045
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6650730/
Description
Cited article made available by the US National Library of Medicine, National Institutes of Health

Learn more about this trial

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

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