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    Clinical Trial Results:
    Double umbilical cord blood transplantation in high-risk hematological patients. A phase II study focussing on the mechanism of graft predominance

    Summary
    EudraCT number
    		 2012-001188-55
    Trial protocol
    		 NL   BE  
    Global end of trial date
    28 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2023
    First version publication date
    28 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON115
    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 , +31 0107041560, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON , +31 0107041560, 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
    15 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the presence of an alloreactive immune response of CD4+ T-cells of the predominant CBU, directed against the non-engrafting CBU as a causative mechanism in CBU predominance.
    Protection of trial subjects
    Monitoring and Insurance.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2012
    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
    Netherlands: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    62
    From 65 to 84 years
    8
    85 years and over
    0

    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
    Cord blood unit
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in administration system
    Routes of administration
    Intravenous use
    Dosage and administration details
    minimum TNC dose of 4x10^7/kg recipient body weight

    Number of subjects in period 1
    		Experimental Group
    Started
    70
    Completed
    45
    Not completed
    25
         Other
    5
         Lack of efficacy
    20

    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
    		 70 70
    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)
    		 62 62
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (20 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 36 36

    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
    See publication.
    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: See attached chart/documents for results.
    End point values
    		 Experimental Group
    Number of subjects analysed
    70
    Units: Whole
    70
    Attachments
    		 List of reported non-SAE's
    List of reported SAE's
    Statistical data section from publication
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be reported from the first study-related procedure until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under study, if earlier.
    Adverse event reporting additional description
    Adverse events occurring after 30 days should also be reported if considered at least possibly related to the investigational medicinal product by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    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
    34 / 68 (50.00%)
         number of deaths (all causes)
    33
         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 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    9 / 68 (13.24%)
         occurrences causally related to treatment / all
    10 / 10
         deaths causally related to treatment / all
    5 / 5
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    3 / 4
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Blood and lymphatic disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences causally related to treatment / all
    7 / 7
         deaths causally related to treatment / all
    1 / 1
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    10 / 68 (14.71%)
         occurrences causally related to treatment / all
    4 / 10
         deaths causally related to treatment / all
    1 / 2
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         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
    64 / 68 (94.12%)
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    18 / 68 (26.47%)
         occurrences all number
    19
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    5
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Investigations
    Investigations
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    26 / 68 (38.24%)
         occurrences all number
    47
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences all number
    7
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 68 (13.24%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Blood and lymphatic disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    29 / 68 (42.65%)
         occurrences all number
    38
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    20 / 68 (29.41%)
         occurrences all number
    23
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    8 / 68 (11.76%)
         occurrences all number
    8
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 68 (13.24%)
         occurrences all number
    9
    Endocrine disorders
    Endocrine disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    4
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    41 / 68 (60.29%)
         occurrences all number
    94
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    24 / 68 (35.29%)
         occurrences all number
    37

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2013
    adjusted age to ≤ 70 years, secondary end point ‘transplant related mortality’ as primary end point.

    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
    For support, Contact us.
    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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