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    Clinical Trial Results:
    Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg) 90Y-ibritumomab tiuxetan ("Zevalin") in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77)

    Summary
    EudraCT number
    		 2005-003796-20
    Trial protocol
    		 BE  
    Global end of trial date
    12 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jan 2023
    First version publication date
    29 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON 77
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, hdc@erasmusmc.nl
    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 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the conversion rate from PET-positive to PET-negative residual masses after 90Y-ibritumomab tiuxetan treatment in patients with PET-positive partial remission following first-line R-CHOP chemotherapy.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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
    17
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria.

    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
    		 Experimental Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Mabthera
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    250mg/m2, day -7 and 0

    Investigational medicinal product name
    90Y-ibritumomab tiuxetan
    Investigational medicinal product code
    Other name
    Zevalin
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    14.8MBq/kg (max dose 1184 MBq or 31mCi), day 0.

    Number of subjects in period 1
    		Experimental Group
    Started
    19
    Completed
    9
    Not completed
    10
         Lack of efficacy
    10

    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
    		 19 19
    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)
    		 1 1
        From 65-84 years
    		 17 17
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 73 (63 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    Primary endopoint is dan complete response on FDG-PET (i.e. PET-negative residual masses) at 3 and 6 months after radioimmunotherapy.
    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 article has been published for this trial.
    End point values
    		 Experimental Group
    Number of subjects analysed
    17
    Units: Whole
    17
    Attachments
    		 List of reported non-SAE's
    List of reported SAE's
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be reported on the CRF. All adverse events of Grade 2 or higher, with the exception of progression of disease, occurring during the protocol treatment period will be reported.
    Adverse event reporting additional description
    Adverse events occurring after that period should also be reported if considered related to protocol treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 19 (15.79%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 19 (42.11%)
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Blood/bone marrow
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    5
    General disorders and administration site conditions
    Constitutional symptoms
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Pain
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Gastrointestinal disorders
    GI
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Dermatology/skin
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2

    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
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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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