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    Clinical Trial Results:
    A Phase II Trial of Idelalisib in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma.

    Summary
    EudraCT number
    		 2016-001058-16
    Trial protocol
    		 SE   DK  
    Global end of trial date
    30 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2021
    First version publication date
    28 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NLG-LBC-07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03576443
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Skåne University Hospital
    Sponsor organisation address
    Gettingevägen 4, Lund, Sweden, 221 85
    Public contact
    Karin Fjordén, Skåne University Hospital, Department of Oncology, +46 4617 75 20, karin.fjorden@med.lu.se
    Scientific contact
    Karin Fjordén, Skåne University Hospital, Department of Oncology, +46 4617 75 20, karin.fjorden@med.lu.se
    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
    04 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of idelalisib in patients with relapsed/refractory diffuse large B-cell lymphoma.
    Protection of trial subjects
    The responsible investigator will ensure that this study is conducted in agreement with the declaration of Helsinki, Fortaleza, Brazil, October 2013 and the laws and the regulations of the country. The protocol has been written, and the study will be conducted according to the guidelines for Good Clinical Practice, issued by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). As a pre-requirement for implementation, the protocol will have to be approved by the local, regional or national Ethical Review Boards according to the existing national and local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2017
    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
    Sweden: 27
    Country: Number of subjects enrolled
    Denmark: 9
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    4
    From 65 to 84 years
    29
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled 07-Jul-2017 Last patient enrolled 22-Apr-2020

    Pre-assignment
    Screening details
    		 2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either: a. Refractory disease b. Persistent disease

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

    Arms
    Arm title
    		 Overall Trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    idelalisib
    Investigational medicinal product code
    Other name
    Zydelig
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg BID p.o. until progression

    Number of subjects in period 1
    		Overall Trial
    Started
    36
    Completed
    30
    Not completed
    6
         Physician decision
    1
         Adverse event, non-fatal
    5

    Baseline characteristics

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

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 36 36
    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)
    		 4 4
        From 65-84 years
    		 29 29
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Primary: Overall response rate

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    End point title
    		 Overall response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    Response was evaluated at weeks 8, 16, 24 and every 12 weeks thereafter, until 108 weeks after start of therapy
    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: This is a single arm study. Please refer to the published study
    End point values
    		 Overall Trial
    Number of subjects analysed
    36
    Units: subjects
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs will be recorded from the time the subject signs informed consent to 28 days after the last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 36 (50.00%)
         number of deaths (all causes)
    26
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Vomiting
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Dehydration
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Haemolysis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Tumour haemorrhage
    Additional description: GI Bleeding
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Ascites
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 36 (97.22%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 36 (22.22%)
         occurrences all number
    8
    Neutropenia
         subjects affected / exposed
    6 / 36 (16.67%)
         occurrences all number
    6
    Thrombocytopenia
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 36 (19.44%)
         occurrences all number
    7
    Hepatobiliary disorders
    Transaminases increased
         subjects affected / exposed
    12 / 36 (33.33%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences all number
    5
    Infections and infestations
    Infection
         subjects affected / exposed
    10 / 36 (27.78%)
         occurrences all number
    10
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3

    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.
    The trial was terminated prematurely afterrecruiting half of the originally planned number of patients due to futility in reaching the primary end-point

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34435356
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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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