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    Clinical Trial Results:
    A PHASE II TRIAL OF LONG-TERM TREATMENT WITH AZITHROMYCIN IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT) LYMPHOMA

    Summary
    EudraCT number
    		 2016-001521-13
    Trial protocol
    		 AT  
    Global end of trial date
    11 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2021
    First version publication date
    26 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MALT-A1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Wien, Austria, 1090
    Public contact
    Marika Rosner, MedUniWien, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Markus Raderer, MedUniWien, +43 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
    14 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the capacity of azithromycin to induce objective responses in patients with MALT lymphoma, either untreated or at relapse after surgery, radiation and chemotherapy. In addition, also patients with disease refractory to HP-eradication after a minimum follow-up of 12 months will be enrolled. Patients with gastric MALT lymphoma and no evidence of HP-infection (as judged by histology and ultimately serology) may be enrolled immediately.
    Protection of trial subjects
    no protection needed for this IMP
    Background therapy
    		 no background therapy needed for this IMP
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2016
    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
    9
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment was done through the outpatient clinic unit

    Pre-assignment
    Screening details
    		 The screening was done on the basis of 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
    		 Azithromycin
    Arm description
    		 Single arm study, all patients receive azithromycin
    Arm type
    		 Experimental

    Investigational medicinal product name
    azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1500mg azithromycin once a week

    Number of subjects in period 1
    		Azithromycin
    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
    		 9 9
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    objective response rate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    sinons rule set

    Subject analysis sets values
    		 objective response rate
    Number of subjects
    16
    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)
    6
        From 65-84 years
    9
        85 years and over
    1
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 Single arm study, all patients receive azithromycin

    Subject analysis set title
    objective response rate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    sinons rule set

    Primary: Rate of objective responses

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    End point title
    		 Rate of objective responses
    End point description
    End point type
    Primary
    End point timeframe
    after 24 weeks
    End point values
    		 Azithromycin objective response rate
    Number of subjects analysed
    16
    16
    Units: numbers
    16
    16
    Statistical analysis title
    		 Objective response rate
    Comparison groups
    Azithromycin v objective response rate
    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
    Confidence interval
    Notes
    [1] - descreptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time of signing the informed consent through to the end of the designated follow-up period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    unspecific Adverse Events
    Reporting group description
    		 Toxicities were mainly mild and mostly unspecific

    Serious adverse events
    		 unspecific Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    General disorder due to MALT lymphoma
    Additional description: General disorder due to MALT lymphoma nrelated to the IMP.
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 unspecific Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 16 (81.25%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Chills
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Vertigo
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea/Vomiting
         subjects affected / exposed
    13 / 16 (81.25%)
         occurrences all number
    13
    gastrointestinal complaints
    Additional description: gastrointestinal complaints (including flatulence, bloating, and cramps, dyspepsia)
         subjects affected / exposed
    12 / 16 (75.00%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint pain
         subjects affected / exposed
    1 / 16 (6.25%)
         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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30153341
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