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    Clinical Trial Results:
    A phase 3 randomised non-inferiority trial to evaluate the use of imatinib, nilotinib and ponatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia

    Summary
    EudraCT number
    2012-005696-14
    Trial protocol
    GB  
    Global end of trial date
    16 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    File Note - Study Withdrawn

    Trial information

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    Trial identification
    Sponsor protocol code
    6451
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Level 1, Regent Point, Regent Farm Road, Newcastle upon Tyne, United Kingdom, NE3 3HD
    Public contact
    Professor Stephen O'Brien, Newcastle University, 0044 0191 282 0904, stephen.o'brien@ncl.ac.uk
    Scientific contact
    Professor Stephen O'Brien, Newcastle University, 0044 0191 282 0904, stephen.o'brien@ncl.ac.uk
    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
    16 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study aims to see if treatment with imatinib is as good as treatment with nilotinib when patients in either group who are not doing so well switch to ponatinib. The response to treatment is measured in the blood and tests will look for leukaemic cells.
    Protection of trial subjects
    This study was terminated prior to the recruitment of any participants, therefore no results are available. As a result, where '9999999' is entered this means the data point is N/A.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 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
    United Kingdom: 9999999
    Worldwide total number of subjects
    9999999
    EEA total number of subjects
    9999999
    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)
    9999999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The protocol stated that patients would be screened for eligibility to take part in the trial. Screening assessments included: Demography, CML diagnosis, medical history, concomitant medication, haematology, biochemistry, blood glucose, physical examination and Blood Pressure measurement.

    Pre-assignment period milestones
    Number of subjects started
    9999999
    Number of subjects completed
    9999999

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Imatinib
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg daily (taken OD)

    Arm title
    nilotinib
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Nilotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg daily (taken as 300mg BD)

    Number of subjects in period 1
    Imatinib nilotinib
    Started
    6666666
    3333333
    Completed
    6666666
    3333333

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Imatinib
    Reporting group description
    -

    Reporting group title
    nilotinib
    Reporting group description
    -

    Primary: Major molecular response (MMR)

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    End point title
    Major molecular response (MMR) [1]
    End point description
    This study was terminated prior to the recruitment of any participants, therefore no end point data was collected. As a result, where '9999999' is entered this means the data point is N/A.
    End point type
    Primary
    End point timeframe
    Major molecular response (MMR) at 3 years on trial
    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 study was terminated prior to the recruitment of any participants, therefore no end point data is available. As a result, where '9999999' is entered within the EudraCT report, this means the data point is N/A.
    End point values
    Imatinib nilotinib
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: %
    Notes
    [2] - Study terminated prior to the recruitment of any participants, therefore no end point data available
    [3] - Study terminated prior to the recruitment of any participants, therefore no end point data available
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This study was terminated prior to the recruitment of any participants, therefore no results are available and no adverse events were reported. As a result, where '9999999' is entered this means the data point is N/A.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Protocol
    Dictionary version
    2
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This study was terminated prior to the recruitment of any participants, therefore no AEs were reported. As a result, where '9999999' is entered this means the data point is N/A.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2016
    Protocol amendment to update cardiovascular safety profile. To incorporate another TKI (dasatinib) into the trial design as a first line treatment. To include the TKI bosutinib as an option for participants who do not tolerate their first line medication. To make changes and additions to the participant-facing documentation. (Following submission of this amendment, the trial was later terminated before recruitment was initiated).

    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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