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    Clinical Trial Results:
    Low-dose IL-2 to expand endogenous regulatory T cells and achieve tolerance in liver transplantation

    Summary
    EudraCT number
    		 2017-000177-37
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2020
    First version publication date
    21 Feb 2020
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    LITE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02949492
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Prof Alberto Sanchez-Fueyo, King's College London, +44 0207848 5883, sanchez_fueyo@kcl.ac.uk
    Scientific contact
    Prof Alberto Sanchez-Fueyo, King's College London, +44 0207848 5883, sanchez_fueyo@kcl.ac.uk
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Prof Alberto Sanchez-Fueyo, King's College Hospital, +44 0207848 5883, sanchez_fueyo@kcl.ac.uk
    Scientific contact
    Prof Alberto Sanchez-Fueyo, King's College Hospital, +44 0207848 5883, sanchez_fueyo@kcl.ac.uk
    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
    30 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine the capacity of a short course of low-dose IL-2 to facilitate the complete discontinuation of immunosuppressive drugs in liver recipients 2-6 years after transplantation.
    Protection of trial subjects
    To assess safety during the administration of IL-2 and the discontinuation of IS, participants will undergo frequent blood tests that will include full blood cell count, Na, K, creatinine, AST, ALT bilirubin, GGT and alkaline phosphatase as follows: • Between Baseline Visit and Treatment Visit 2 patients will undergo blood tests every week. • Between Treatment Visit 2 and Treatment Visit 4 patients will undergo blood tests at least every 2 weeks. • Between Treatment Visit 4 and Treatment Visit 5 patients will require performance of blood tests at least every 3 weeks. Adverse events will be monitored from screening to last visit. Patients will also be contacted by telephone after each blood test to discuss the results and enquire about potential adverse events. Furthermore, patients will undergo a full physical examination and vital signs at the time of each trial visit. Finally, patients will undergo protocol liver biopsies during the Screening Visit 2, following 4 weeks of IL-2 treatment (Treatment Visit 2), 12 months following IS discontinuation (Treatment Visit 5), and at any time during the duration of the study if they develop allograft dysfunction.
    Background therapy
    		 At the time of enrolment participants will be treated with tacrolimus or cyclosporine A with/without mycophenolate mofetil/mycophenolic acid or azathioprine. All these specified immunosuppressive pharmacological drugs are commercially available and are licensed and have marketing authorisations as part of the standard of care in liver transplantation. These drugs therefore constitute a background therapy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2017
    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
    United Kingdom: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants who underwent liver transplantation at Kings College Hospital and who are 6 to 12 months post liver transplantation will be selected according to the inclusion criteria. The trial specifically excludes transplant recipients that are at increased risk of acute cellular rejection and, recurrent disease.

    Period 1
    Period 1 title
    Whole trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was not blinded

    Arms
    Arm title
    		 Proleukin
    Arm description
    		 llver recipients ≤50 years old and 2-6 years after transplantation will receive IL-2 and gradually discontinue their immunosuppressive medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Proleukin
    Investigational medicinal product code
    Other name
    Aldesleukin
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 - 2 million IU million international units per day. Subcutaneous Use

    Number of subjects in period 1
    		Proleukin
    Started
    6
    Completed
    0
    Not completed
    6
         Trial was terminated early
    6

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Proleukin
    Reporting group description
    		 llver recipients ≤50 years old and 2-6 years after transplantation will receive IL-2 and gradually discontinue their immunosuppressive medication.

    Primary: Successful IS withdrawal at 1 year

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    End point title
    		 Successful IS withdrawal at 1 year [1]
    End point description
    Primary efficacy outcome measure was successful IS withdrawal as defined by the absence of rejection and a rejection free biopsy at 1year following IS discontinuation.
    End point type
    Primary
    End point timeframe
    Successful IS withdrawal at 1 year
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The trial was ended early and no statistical analysis was possible. Please see attached results.
    End point values
    		 Proleukin
    Number of subjects analysed
    6 [2]
    Units: Successful IS withdrawal at 1 year
    0
    Attachments
    		 Summary data
    Notes
    [2] - No subjects reached the primary endpoint
    No statistical analyses for this end point

    Secondary: Allograft dysfunction

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    End point title
    		 Allograft dysfunction
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 5
    End point values
    		 Proleukin
    Number of subjects analysed
    5
    Units: Number of subjects
    5
    No statistical analyses for this end point

    Secondary: Allograft rejection

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    End point title
    		 Allograft rejection
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 5
    End point values
    		 Proleukin
    Number of subjects analysed
    6
    Units: Number of subjects
    6
    No statistical analyses for this end point

    Secondary: Patient graft survival

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    End point title
    		 Patient graft survival
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 5
    End point values
    		 Proleukin
    Number of subjects analysed
    5
    Units: Number of subjects
    5
    No statistical analyses for this end point

    Secondary: Patients underwent IS withdrawal

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    End point title
    		 Patients underwent IS withdrawal
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 5
    End point values
    		 Proleukin
    Number of subjects analysed
    5
    Units: Number of subjects
    5
    No statistical analyses for this end point

    Secondary: Failure of IS withdrawal

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    End point title
    		 Failure of IS withdrawal
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and visit 5
    End point values
    		 Proleukin
    Number of subjects analysed
    3
    Units: Number of subjects
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from consent to last patient visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Whole trial
    Reporting group description
    		 -

    Serious adverse events
    		 Whole trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Severe Rejection Episode
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic artery pseudoaneurysm
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Surgical and medical procedures
    Teeth extraction
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    Headache1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hypereosinophilia
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    Gastrointestinal disorders
    Loose stools
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Coryzal symptoms
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Injection site reaction
         subjects affected / exposed
    5 / 6 (83.33%)
         occurrences all number
    5
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2018
    Inclusion criteria Inclusion criteria has been updated to include subjects less than and including 50 years of age to include more potential participants. Addition of fine needle aspiration Fine needle aspiration is required as an extra purely mechanistic sample, as it is a good representation of liver health. It is easy to obtain and is very low risk to the patients. Additional visit at 7 (+/- 2 days) after baseline visit Added for safety reasons to quantify the number of circulating Tregs. Patients in whom the increase in Tregs is <2-fold as compared to baseline will increase their dose of IL-2 to 1 million IU twice daily, whilst those in whom Tregs increase ≥ 2-fold will remain on 1 million IU daily. Stool and urine samples made non-mandatory The stool and urine samples were changed to optional to avoid protocol violations in case of non-collection. Addition of whole blood gene expression as part of mechanistic lab assessments Update of TSC/DMC meeting timelines TSC/DMC meetings to take place every 6 months. Update to SmPC (RSI)
    25 Jun 2018
    IL-2 dose reduced to 0.5M IU/day after 4 weeks

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    17 Oct 2018
    The trial was halted temporarily due to a participant experiencing chronic rejection which was not anticipated. The trial was not re-started.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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