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    Clinical Trial Results:
    Extracorporeal Photopheresis Treatment in steroid refractory acute and chronic Graft versus Host Disease

    Summary
    EudraCT number
    		 2015-001550-14
    Trial protocol
    		 DK  
    Global end of trial date
    16 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2018
    First version publication date
    07 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ECP-GVHD1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg hospital
    Sponsor organisation address
    Bispebjerg bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Marietta Nygaard, Bispebjerg hospital, 0045 60626201, marietta.nygaard@regionh.dk
    Scientific contact
    Marietta Nygaard, Bispebjerg hospital, 0045 21494386, marietta.nygaard@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of treatment with extracorporeal photopheresis in acute and chronic GVHD.
    Protection of trial subjects
    There were no specific measures to protect subjects, as they received the usual treatment in the department.
    Background therapy
    		 Given the nature of the disease Graft versus Host Disease and the preceeding bone marrow transplantation, the patients usually recieved many other treatments. This was usually transfusions of red blood cells or platelets, or infection prophylaxis and almost all patients also received one or more immunosuppressive drugs. The latter drugs were given to treat graft versus host disease, but was always administerered at the discretion of the treating physiscian. These drugs may very well have interfered with the effect of extracorporeal photopheresis.
    Evidence for comparator
    		 We used no comparators
    Actual start date of recruitment
    07 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients referred to extracoporeal photopheresis between 07.07.2015 (first patient enrolled) and 16.09.2016 (trial ended prior to plan) were enrolled.

    Pre-assignment
    Screening details
    		 Inclusion criteria were not very strict as it was an observational trial with no control group. All patients referred to extracorporeal photopheresis were screened by sponsor/investigator (MN) and all were enrolled.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 chronic
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uvadex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dependent on amount of collected blood

    Arm title
    		 Acute
    Arm description
    		 PAtietns with acute GvHD
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uvadex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dependent on amount of collected blood

    Number of subjects in period 1
    		chronic Acute
    Started
    10
    13
    Completed
    10
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 All patients treated with extracorporeal photopheresis

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 55 (31 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Chronic GvHD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with chronic GvHD

    Subject analysis set title
    Acute GvHD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with acute GvHD

    Subject analysis sets values
    		 Chronic GvHD Acute GvHD
    Number of subjects
    10
    13
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    7
    9
        From 65-84 years
    3
    4
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    chronic
    Reporting group description
    		 -

    Reporting group title
    Acute
    Reporting group description
    		 PAtietns with acute GvHD

    Subject analysis set title
    Chronic GvHD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with chronic GvHD

    Subject analysis set title
    Acute GvHD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with acute GvHD

    Primary: Best or overall response

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    End point title
    		 Best or overall response
    End point description
    The overall (cGvHD) or best response (AGvHD) during treatment with ECP
    End point type
    Primary
    End point timeframe
    overall trial
    End point values
    		 Chronic GvHD Acute GvHD
    Number of subjects analysed
    10
    13
    Units: number of patients
        Complete remission
    1
    10
        Very Good Partial Remission
    0
    1
        Partial Remission
    6
    0
        No Change
    2
    0
        Progressive Disease
    1
    2
    Statistical analysis title
    		 None
    Statistical analysis description
    No statistical analysis were made because the groups are not comparable. They are two different diseases.
    Comparison groups
    Chronic GvHD v Acute GvHD
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 No comparison made
    Confidence interval
    Notes
    [1] - No comparisons can be made.
    [2] - No comparisons made

    Secondary: Survival at one year after start of treatment

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    End point title
    		 Survival at one year after start of treatment
    End point description
    Number of patients alive one year from start of treatment
    End point type
    Secondary
    End point timeframe
    1 year from start of treatment
    End point values
    		 Chronic GvHD Acute GvHD
    Number of subjects analysed
    Units: Number of patients alive
        Alive
    10
    7
        Dead
    0
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of trial and until first amendment, where the reporting of adverse events were changed.
    Adverse event reporting additional description
    Given the nature of the graft versus host disease and the circumstances under which the patients receive treatment, there are expected to be many serious events during the treatment course, these are not expected to be related to the ECP treatment but rather to the bone marrow transplantation and/or the concurrent immunosuppressive drugs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: In the amendment it is specified, why the reporting of adverse events is difficult, due to the nature of the studied diseases and the competing uncontrolled therapies. It was never an aim of this study to examine safety.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Nov 2015
    Change of the reporting of Adverse events because the patients were influenced by many other drugs and circumstances causing abnormal testings, infections and other complications.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Oct 2016
    The trial was ended pre-term
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was never finished because it turned out to be impossible to perfom it meaningfully
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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