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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01380535
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : October 29, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Mallinckrodt

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.


Condition or disease Intervention/treatment Phase
Chronic Graft Versus Host Disease Drug: ECP Methoxsalen Drug: Standard of Care Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot Study for the 2015 NIH Consensus Criteria to inform the design of subsequent studies
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: ECP Methoxsalen + Standard of Care
Participants receive methoxsalen administered via ECP in addition to standard of care
Drug: ECP Methoxsalen
Methoxsalen delivered by ECP
Other Names:
  • Uvadex
  • Extracorporeal photopheresis (ECP)

Drug: Standard of Care
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Other Name: Reference therapy

Active Comparator: Standard of Care
Participants receive standard of care only
Drug: Standard of Care
Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Other Name: Reference therapy




Primary Outcome Measures :
  1. Number of Participants With an Overall Response at Week 28 [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. safety and well-being of participant or offspring
    2. safety of study staff
    3. analysis of results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380535


Locations
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Sponsors and Collaborators
Mallinckrodt
Parexel
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
Additional Information:
Publications of Results:
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01380535    
Other Study ID Numbers: 10-005
2010-022780-35 ( EudraCT Number )
First Posted: June 27, 2011    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt:
Extracorporeal photopheresis therapy
Methoxsalen
cGVHD
hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Methoxsalen
Photosensitizing Agents
Dermatologic Agents