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    Clinical Trial Results:
    A Phase II trial of Ofatumumab in patients with lymphoma of the of the mucosa associated lymphoid tissue (MALT-Lymphoma)

    Summary
    EudraCT number
    		 2012-005223-32
    Trial protocol
    		 AT  
    Global end of trial date
    19 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2021
    First version publication date
    16 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    O-Ma 1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Marika Rosner, Medizinische Universität Wien, 0043 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Ao. Prof. Dr. Markus Raderer, Medizinische Universität Wien, 0043 14040044450, markus.raderer@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
    29 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of IMP in patients with MALT-Lymphoma
    Protection of trial subjects
    CT thorax and abdomen and endoscopy at screening, week 12, 24 and 42
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2013
    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
    Austria: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was done through the outpatient clinic unit

    Pre-assignment
    Screening details
    		 The screening was based on the screening criteria

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

    Arms
    Arm title
    		 Ofatumumab
    Arm description
    		 Single arm study, all patients receive ofatumumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg i.v weekly for 4 weeks followed by 4 cycles every 2 month

    Number of subjects in period 1
    		Ofatumumab
    Started
    16
    Completed
    16

    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
    		 16 16
    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)
    		 6 6
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Ofatumumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single arm study, all patients receive ofatumumab

    Subject analysis sets values
    		 Ofatumumab
    Number of subjects
    16
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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 65-84 years
    10
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    9
        Male
    7

    End points

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    End points reporting groups
    Reporting group title
    Ofatumumab
    Reporting group description
    		 Single arm study, all patients receive ofatumumab

    Subject analysis set title
    Ofatumumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single arm study, all patients receive ofatumumab

    Primary: Objective responses rate

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    End point title
    		 Objective responses rate
    End point description
    End point type
    Primary
    End point timeframe
    after 24 weeks
    End point values
    		 Ofatumumab Ofatumumab
    Number of subjects analysed
    16
    16
    Units: 15
        number (not applicable)
    15
    15
    Statistical analysis title
    		 Objective responses rate
    Comparison groups
    Ofatumumab v Ofatumumab
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.4
    Method
    		 Simon`s two stage design
    Parameter type
    		 descreptive
    Confidence interval
         level
    		 95%
    Variability estimate
    Standard deviation
    Notes
    [1] - per protocol

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from signing informed consent throught the end of FU period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CI CTCAE
    Dictionary version
    V3.0
    Reporting groups
    Reporting group title
    specific and unspecific Adverse Events
    Reporting group description
    		 Toxicities were mainly mild

    Serious adverse events
    		 specific and unspecific Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (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
    		 specific and unspecific Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Product issues
    infusions reactions
    Additional description: reactions due to ofatumumab
         subjects affected / exposed
    14 / 14 (100.00%)
         occurrences all number
    14

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28695630
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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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