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    Clinical Trial Results:
    Treatment of chronic lymphocytic leukemia with the use of an antiviral compound - a proof of principle study

    Summary
    EudraCT number
    		 2010-021786-78
    Trial protocol
    		 AT  
    Global end of trial date
    18 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V1_30.4.2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of VIenna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Department of Medicine I, Medical University of Vienna, 0043 14040044400, christoph.steininger@meduniwien.ac.at
    Scientific contact
    Department of Medicine I, Medical University of Vienna, +43 14040044400, christoph.steininger@meduniwien.ac.at
    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
    26 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the response of CLL patients to a three months course of antiviral prophylaxis as measured by the kinetics of the absolute lymphocyte count of CLL patients
    Protection of trial subjects
    Detailled assessment of history of allergic reactions, contraindications and risk for adverse reactions to study medication, patient health insurance and external monitoring was done to minimize potential adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jul 2010
    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
    Austria: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    3
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Our institution (Department of Medicine I, Medical University of Vienna) is a university-affiliated, tertiary care centre. The Department of Hematology is internationally renowned for its expertise in neoplasias of the blood and lymphatic tissue. A total of 8 patients was recruited.

    Pre-assignment
    Screening details
    		 Signed informed consent was obtained from all patients prior to any specific procedure. The investigator confirmed eligibility of the patient according to the inclusion and exclusion criteria. Screening and baseline visit occurred within 12 weeks of the first IMP administration.

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

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Each patient will participate in a screening period, a baseline visit, a treatment phase of approximately 3 months within at least 3 visits at site and a follow-up period of 9 months including 3 follow up visits, every 3 months, at site. Valganciclovir (VGCV) at a dose of 900 mg (2x 450mg tablets) once daily (dosage will be adapted in patients with renal insufficiency) will be used as antiviral prophylaxis for 3 months.
    Arm type
    		 Proof-of-principle

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    n/a
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Valganciclovir (VGCV) at a dose of 900 mg (2x 450mg tablets) once daily (dosage was adapted in patients with renal insufficiency) was used as antiviral prophylaxis for 3 months.

    Number of subjects in period 1
    		Treatment
    Started
    8
    Completed
    7
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 8 8
    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)
    		 3 3
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Assessment of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    kinetics of the total lymphocyte count before, during, and up to 9 months after antiviral therapy

    Subject analysis sets values
    		 Assessment of treatment
    Number of subjects
    7
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    3
        From 65-84 years
    5
        85 years and over
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    2
        Male
    5

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Each patient will participate in a screening period, a baseline visit, a treatment phase of approximately 3 months within at least 3 visits at site and a follow-up period of 9 months including 3 follow up visits, every 3 months, at site. Valganciclovir (VGCV) at a dose of 900 mg (2x 450mg tablets) once daily (dosage will be adapted in patients with renal insufficiency) will be used as antiviral prophylaxis for 3 months.

    Subject analysis set title
    Assessment of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    kinetics of the total lymphocyte count before, during, and up to 9 months after antiviral therapy

    Primary: Lymphocyte count at 12 months

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    End point title
    		 Lymphocyte count at 12 months
    End point description
    End point type
    Primary
    End point timeframe
    Lymphocyte count at 12 months
    End point values
    		 Treatment Assessment of treatment
    Number of subjects analysed
    8
    7
    Units: Number per liter
        number (not applicable)
    8
    7
    Statistical analysis title
    		 Change in lymphocyte count
    Statistical analysis description
    Patients receiving antiviral therapy and harbouring CMV will benefit from treatment which should result in a reduction of lymphocyte counts due to newly formed lymphocytes undergoing normal apoptotic behaviour. Under this assumption during 3 months of treatment the reduction of lymphocyte counts should amount to about 5-10% in CMV positive patients. Assuming a reduction of this magnitude will amount to a standardized effect size of about 0.3 and a correlation of 0.8 between log lymphocyte counts
    Comparison groups
    Treatment v Assessment of treatment
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 n/a
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: Mild myalgia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    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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