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    Clinical Trial Results:
    Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)

    Summary
    EudraCT number
    		 2022-000763-45
    Trial protocol
    		 IT   ES   SE   BE  
    Global end of trial date
    31 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2024
    First version publication date
    01 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P-105-401
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AlloVir, Inc.
    Sponsor organisation address
    1100 Winter Street, Waltham, United States, MA 02451
    Public contact
    Clinical Trials Information Line, AlloVir, Inc., +1 617-433-2605, clinicaltrials@allovir.com
    Scientific contact
    Clinical Trials Information Line, AlloVir, Inc., +1 617-433-2605, clinicaltrials@allovir.com
    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
    31 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the long-term safety of posoleucel (PSL).
    Protection of trial subjects
    This study was performed in accordance with Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 Physicians prescribed treatments based on usual clinical practice, and there were no restrictions on the use of medications.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 151
    Worldwide total number of subjects
    237
    EEA total number of subjects
    49
    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)
    11
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    159
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 237 participants were enrolled at 76 sites in 11 countries between January 2022 and January 2024. Two participants with unknown age at enrollment were reported within the Adults (18-64 years) category.

    Pre-assignment
    Screening details
    		 The purpose of this registry was to provide long-term follow-up for participants in PSL clinical trials sponsored by AlloVir, Inc. Participants were eligible to enroll into this observational registry from posoleucel parent studies AVM-003-HC, P-105-201, P-105-202 and P-105-303.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P-105-201: Placebo
    Arm description
    		 Participants received at least one intravenous infusion of placebo in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-201 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 P-105-201: Posoleucel
    Arm description
    		 Participants received at least one intravenous infusion of PSL in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-201 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Posoleucel
    Investigational medicinal product code
    ALVR105
    Other name
    PSL, ALVR-105, Viralym-M
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 P-105-202: Placebo
    Arm description
    		 Participants received at least one intravenous infusion of placebo in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-202 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 P-105-202: Posoleucel
    Arm description
    		 Participants received at least one intravenous infusion of PSL in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-202 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Posoleucel
    Investigational medicinal product code
    ALVR105
    Other name
    PSL, ALVR-105, Viralym-M
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 AVM-003-HC: Placebo
    Arm description
    		 Participants received at least one intravenous infusion of placebo in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the AVM-003-HC parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 AVM-003-HC: Posoleucel
    Arm description
    		 Participants received at least one intravenous infusion of PSL in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the AVM-003-HC parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Posoleucel
    Investigational medicinal product code
    ALVR105
    Other name
    PSL, ALVR-105, Viralym-M
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 P-105-303: Placebo
    Arm description
    		 Participants received at least one intravenous infusion of placebo in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-303 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Arm title
    		 P-105-303: Posoleucel
    Arm description
    		 Participants received at least one intravenous infusion of PSL in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-303 parent study. No treatment was provided in this registry.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Posoleucel
    Investigational medicinal product code
    ALVR105
    Other name
    PSL, ALVR-105, Viralym-M
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion in PSL parent study. No treatment was provided in this registry.

    Number of subjects in period 1
    		P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Started
    18
    34
    69
    82
    11
    16
    4
    3
    Completed
    0
    1
    0
    0
    0
    0
    0
    0
    Not completed
    18
    33
    69
    82
    11
    16
    4
    3
         Consent withdrawn by subject
    -
    -
    -
    -
    1
    -
    -
    -
         Death
    -
    1
    3
    2
    3
    1
    -
    -
         Requested discontinuation from the registry
    -
    -
    -
    -
    -
    1
    -
    -
         Study terminated by the sponsor
    18
    32
    66
    80
    7
    14
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    P-105-201: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-201: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-303 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-303 parent study. No treatment was provided in this registry.

    Reporting group values
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel Total
    Number of subjects
    		 18 34 69 82 11 16 4 3 237
    Age categorical
    Units: Subjects
        <2 years
    		 0 0 0 0 0 0 0 0 0
        2 - <6 years
    		 0 0 1 0 0 0 0 0 1
        6 - <12 years
    		 0 0 2 4 0 0 3 2 11
        12 - <18 years
    		 0 0 1 2 0 0 1 1 5
        ≥18 years
    		 18 34 64 75 11 16 0 0 218
        Missing
    		 0 0 1 1 0 0 0 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.3 ( 6.87 ) 55.8 ( 14.09 ) 51.2 ( 17.35 ) 53.2 ( 17.96 ) 47.2 ( 19.09 ) 45.3 ( 18.45 ) 8.5 ( 3.32 ) 9.0 ( 2.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 25 40 6 6 2 0 89
        Male
    		 14 28 43 41 5 10 2 3 146
        Missing
    		 0 0 1 1 0 0 0 0 2
    Race
    Units: Subjects
        American Indian or Alaskan Native
    		 0 0 0 0 0 1 0 0 1
        Asian
    		 5 4 15 15 2 4 1 0 46
        Black or African American
    		 5 10 1 3 1 2 0 0 22
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 0 0 1 0 0 2
        White
    		 8 15 44 47 7 7 3 3 134
        Other, Not Listed Above
    		 0 3 1 3 0 0 0 0 7
        Not Available/Not Permitted
    		 0 2 6 13 1 1 0 0 23
        Missing
    		 0 0 1 1 0 0 0 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 4 10 5 1 3 0 1 25
        Not Hispanic or Latino
    		 17 29 51 62 9 12 4 2 186
        Unknown
    		 0 0 0 2 0 0 0 0 2
        Not Collected or Not Reported
    		 0 1 7 12 1 1 0 0 22
        Missing
    		 0 0 1 1 0 0 0 0 2
    Region
    Units: Subjects
        North America
    		 18 34 35 51 6 7 0 1 152
        Other
    		 0 0 34 31 5 9 4 2 85

    End points

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    End points reporting groups
    Reporting group title
    P-105-201: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-201: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-303 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-303 parent study. No treatment was provided in this registry.

    Primary: Number of Participants who Experienced Adverse Drug Reactions (ARDs)

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    End point title
    		 Number of Participants who Experienced Adverse Drug Reactions (ARDs) [1]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An ADR was a response to a medicinal product which is noxious and unintended. Response in this context meant that causal relationship between the medical product and an AE is at least a reasonable possibility. A serious AE or serious ADR (SADR) was an AE (or ADR) that met any of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)-E2A Guideline criteria. The Enrolled Population consisted of all eligible participants who had a signed informed consent.
    End point type
    Primary
    End point timeframe
    Up to a maximum of 4 years after the initial dose of PSL or placebo
    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: No additional statistical analysis was pre-specified for this endpoint.
    End point values
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Number of subjects analysed
    18
    34
    69
    82
    11
    16
    4
    3
    Units: participants
        Any ADRs
    0
    0
    0
    0
    0
    0
    0
    0
        Any SADRs
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced Clinically Significant Infection with Viruses Targeted by PSL

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    End point title
    		 Number of Participants who Experienced Clinically Significant Infection with Viruses Targeted by PSL
    End point description
    Clinically significant infections were defined as any of the following, regardless of relationship to PSL: - Cytomegalovirus infection. - Epstein-Barr virus infection. - Adenovirus infection. - Human herpes virus 6. - BK virus/ Human polyomavirus 1. - John Cunningham virus/ Human polyomavirus 2. The Enrolled Population consisted of all eligible participants who had a signed informed consent.
    End point type
    Secondary
    End point timeframe
    Up to a maximum of 4 years after the initial dose of PSL or placebo
    End point values
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: participants
    Notes
    [2] - Data were not analyzed for this endpoint following early study termination.
    [3] - Data were not analyzed for this endpoint following early study termination.
    [4] - Data were not analyzed for this endpoint following early study termination.
    [5] - Data were not analyzed for this endpoint following early study termination.
    [6] - Data were not analyzed for this endpoint following early study termination.
    [7] - Data were not analyzed for this endpoint following early study termination.
    [8] - Data were not analyzed for this endpoint following early study termination.
    [9] - Data were not analyzed for this endpoint following early study termination.
    No statistical analyses for this end point

    Secondary: Rate of Mortality

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    End point title
    		 Rate of Mortality
    End point description
    Overall mortality was defined as the number of participants deceased. Non-relapse mortality was defined as death without recurrent or progressive disease after transplantation. Values of "99999" indicate result was not available due to missing cause of death. The Enrolled Population consisted of all eligible participants who had a signed informed consent.
    End point type
    Secondary
    End point timeframe
    Up to a maximum of 4 years after the initial dose of PSL or placebo
    End point values
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Number of subjects analysed
    18
    34
    69
    82
    11
    16
    4
    3
    Units: participants
        Overall Mortality (n=18, 34, 69, 82, 11, 16, 4, 3)
    0
    1
    3
    2
    3
    1
    0
    0
        Non-relapse Mortality (n=0, 0, 0, 0, 1, 0, 0, 0)
    0
    99999
    99999
    99999
    0
    99999
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Total number of deaths reported up to a maximum of 4 years after the initial dose of PSL or placebo
    Adverse event reporting additional description
    Treatment-emergent AEs (TEAEs) were not applicable to this study. TEAEs associated with PSL or placebo treatment are reported in the parent study clinicaltrials.gov or EudraCT results disclosure as applicable per local regulations. The Enrolled Population consisted of all eligible participants who had a signed informed consent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    P-105-201: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-201: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-201 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-201 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-201 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-202: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-202 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-202 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-202 parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    AVM-003-HC: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the AVM-003-HC parent study. Eligible participants could have had discontinued from or completed participation in the parent AVM-003-HC study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the AVM-003-HC parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Placebo
    Reporting group description
    		 Participants received at least one intravenous infusion of placebo in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of placebo in the P-105-303 parent study. No treatment was provided in this registry.

    Reporting group title
    P-105-303: Posoleucel
    Reporting group description
    		 Participants received at least one intravenous infusion of PSL in the P-105-303 parent study. Eligible participants could have had discontinued from or completed participation in the parent P-105-303 study. The maximum duration of the registry for each participant was to be 4 years after their initial dose of PSL in the P-105-303 parent study. No treatment was provided in this registry.

    Serious adverse events
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    1
    3
    2
    3
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 P-105-201: Placebo P-105-201: Posoleucel P-105-202: Placebo P-105-202: Posoleucel AVM-003-HC: Placebo AVM-003-HC: Posoleucel P-105-303: Placebo P-105-303: Posoleucel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 34 (0.00%)
    0 / 69 (0.00%)
    0 / 82 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    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: Non-serious TEAEs were not applicable to this study. TEAEs associated with PSL or placebo treatment are reported in the parent study clinicaltrials.gov or EudraCT results disclosure as applicable per local regulations.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2021
    Protocol Amendment 1 was created in order to: - Revise the study objectives and endpoints. - Revise the duration of the follow-up period of the registry. - Revise the number of participants expected to be enrolled in the registry. - Revise the data collected. - Simplify some sections of the protocol.

    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.
    It was planned that up to 500 participants would be enrolled; 237 participants were enrolled (135 in PSL arm and 102 in placebo arm).
    For support, Contact us.
    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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