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    Clinical Trial Results:
    Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib

    Summary
    EudraCT number
    		 2017-003055-30
    Trial protocol
    		 FR   GB   CZ   PL   ES  
    Global end of trial date
    09 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2020
    First version publication date
    07 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-313-4100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03701438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    09 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the immune response to an influenza vaccine in adults with B-cell malignancies who were receiving treatment with idelalisib in a Gilead-sponsored study (parent study: GS-US-313-1580 [NCT02536300]).
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Oct 2018
    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
    Spain: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe. The first participant was screened on 23 October 2018.

    Pre-assignment
    Screening details
    		 2 participants were screened.

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

    Arms
    Arm title
    		 Idelalisib/Influenza Vaccine
    Arm description
    		 Participants who were receiving treatment with idelalisib (100 mg or 150 mg tablets orally twice daily) for at least 7 consecutive days prior to receiving an influenza vaccine in a Gilead-sponsored parent study (GS-US-313-1580 [NCT02536300]), continued to receive idelalisib (per dose and schedule of parent study) along with the influenza vaccine within 7 days of baseline (Day 1) blood sample collection, administered per standard of care using a vaccine licensed and recommended in the site’s country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered per standard of care using a vaccine licensed and recommended in the site's country.

    Investigational medicinal product name
    Idelalisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered per dose and schedule of parent study.

    Number of subjects in period 1
    		Idelalisib/Influenza Vaccine
    Started
    2
    Completed
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Idelalisib/Influenza Vaccine
    Reporting group description
    		 Participants who were receiving treatment with idelalisib (100 mg or 150 mg tablets orally twice daily) for at least 7 consecutive days prior to receiving an influenza vaccine in a Gilead-sponsored parent study (GS-US-313-1580 [NCT02536300]), continued to receive idelalisib (per dose and schedule of parent study) along with the influenza vaccine within 7 days of baseline (Day 1) blood sample collection, administered per standard of care using a vaccine licensed and recommended in the site’s country.

    Reporting group values
    		 Idelalisib/Influenza Vaccine Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Idelalisib/Influenza Vaccine
    Reporting group description
    		 Participants who were receiving treatment with idelalisib (100 mg or 150 mg tablets orally twice daily) for at least 7 consecutive days prior to receiving an influenza vaccine in a Gilead-sponsored parent study (GS-US-313-1580 [NCT02536300]), continued to receive idelalisib (per dose and schedule of parent study) along with the influenza vaccine within 7 days of baseline (Day 1) blood sample collection, administered per standard of care using a vaccine licensed and recommended in the site’s country.

    Primary: Seroconversion Rate: Percentage of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (HI) Titer < 1:10 and a Post-Vaccination HI titer ≥ 1:40, or a Pre-Vaccination HI titer ≥ 1:10 and a ≥ 4-fold Increase in Post-Vaccination HI Titer

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    End point title
    		 Seroconversion Rate: Percentage of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (HI) Titer < 1:10 and a Post-Vaccination HI titer ≥ 1:40, or a Pre-Vaccination HI titer ≥ 1:10 and a ≥ 4-fold Increase in Post-Vaccination HI Titer [1]
    End point description
    End point type
    Primary
    End point timeframe
    28 days (± 7 days) post-vaccination
    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: Due to early termination of study, no efficacy analyses were performed.
    End point values
    		 Idelalisib/Influenza Vaccine
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - Due to early termination of study, no efficacy analyses were performed.
    No statistical analyses for this end point

    Secondary: Seroprotection Rate: Percentage of Participants with HI titer ≥ 1:40 Post-Vaccination

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    End point title
    		 Seroprotection Rate: Percentage of Participants with HI titer ≥ 1:40 Post-Vaccination
    End point description
    End point type
    Secondary
    End point timeframe
    28 days (± 7 days) post-vaccination
    End point values
    		 Idelalisib/Influenza Vaccine
    Number of subjects analysed
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [3] - Due to early termination of study, no efficacy analyses were performed.
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-vaccination and 28 days (± 7 days) post-vaccination
    End point values
    		 Idelalisib/Influenza Vaccine
    Number of subjects analysed
    0 [4]
    Units: titers (1/dilutions)
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [4] - Due to early termination of study, no efficacy analyses were performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events or Serious Adverse Events

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    End point title
    		 Percentage of Participants with Adverse Events or Serious Adverse Events
    End point description
    All Enrolled Analysis Set included all participants who enrolled into the study after screening and had a subject identification number.
    End point type
    Secondary
    End point timeframe
    Date of Informed consent up to Day 28 (post-vaccination visit)
    End point values
    		 Idelalisib/Influenza Vaccine
    Number of subjects analysed
    2
    Units: percentage of participants
    number (not applicable)
        Adverse Events
    100
        Serious Adverse Events
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Date of Informed consent up to Day 28 (post-vaccination visit)
    Adverse event reporting additional description
    All Enrolled Analysis Set included all participants who enrolled into the study after screening and had a subject identification number.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Idelalisib/Influenza Vaccine
    Reporting group description
    		 Participants who were receiving treatment with idelalisib (100 mg or 150 mg tablets orally twice daily) for at least 7 consecutive days prior to receiving an influenza vaccine in a Gilead-sponsored parent study (GS-US-313-1580 [NCT02536300]), continued to receive idelalisib (per dose and schedule of parent study) along with the influenza vaccine within 7 days of baseline (Day 1) blood sample collection, administered per standard of care using a vaccine licensed and recommended in the site’s country.

    Serious adverse events
    		 Idelalisib/Influenza Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (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
    		 Idelalisib/Influenza Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2018
    Based on responses from site selection and feasibility discussions, the protocol was revised to allow participants to receive an influenza vaccination per Standard of Care (SoC) in an inpatient or outpatient medical setting, including but not necessarily limited to hospitals, clinics, health departments, and general practitioner offices. In addition, revisions were made to improve the operational feasibility of the study.
    12 Apr 2018
    Following submission of the clinical trial application via the Voluntary Harmonization Procedure (VHP), Gilead received requests to amend the study from the participating member states in VHP. This protocol amendment addressed the VHP’s requests.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Oct 2019
    Study GS-US-313-4100 was initially planned and conducted to fulfill a post-marketing clinical stipulation from Swissmedic to collect data on the investigation of the impact of idelalisib on the immune system and to submit the study report by no later than 31 October 2020. On 01 October 2019, Swissmedic agreed with Gilead’s request to be released from this stipulation as not enough participants were able to be recruited for this study. As a result, Gilead terminated Study GS-US-313-4100 early. A letter to investigators was issued globally on 09 October 2019 providing notification regarding study termination.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early and only 2 participants were enrolled so no efficacy analyses and no summary analyses were conducted.
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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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