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    Clinical Trial Results:
    Imatinib in combination with Cytarabine as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized phase III study.

    Summary
    EudraCT number
    		 2005-003839-41
    Trial protocol
    		 BE  
    Global end of trial date
    08 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2022
    First version publication date
    24 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON 78 CML
    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
    13 Apr 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of the combination of imatinib with cytarabine as compared to imatinib alone in terms of the rate of molecular response at 12 months from randomization.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 May 2006
    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
    Belgium: 4
    Country: Number of subjects enrolled
    Netherlands: 107
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    1
    Adults (18-64 years)
    108
    From 65 to 84 years
    2
    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
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg (2x400 mg) p.o. daily.

    Arm title
    		 Arm B
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg (2x400 mg) p.o. daily in cycles I-II. 800 mg (2x400 mg) p.o. daily until progression.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cytarabine 200 mg/m2/day i.v. on days 1-7 in cycles I-II.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    55
    56
    Completed
    0
    0
    Not completed
    55
    56
         Adverse reactions
    11
    11
         Other
    41
    43
         Lack of efficacy
    3
    2

    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
    		 111 111
    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)
    		 1 1
        Adults (18-64 years)
    		 108 108
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 45 (17 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 43 43
        Male
    		 68 68

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    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
    		 Arm A Arm B
    Number of subjects analysed
    55
    54
    Units: Whole
    55
    54
    Attachments
    		 Statistical data section from publication
    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
    AE’s 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
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 55 (16.36%)
    24 / 54 (44.44%)
         number of deaths (all causes)
    3
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm benign, malignant and unspecif. (inc. cysts/polyp)
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    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 / 55 (3.64%)
    3 / 54 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Nervous system disorder
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    16 / 54 (29.63%)
         occurrences causally related to treatment / all
    1 / 1
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    3 / 55 (5.45%)
    8 / 54 (14.81%)
         occurrences causally related to treatment / all
    1 / 3
    7 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 55 (90.91%)
    54 / 54 (100.00%)
    Vascular disorders
    Vascular
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
         occurrences all number
    4
    1
    Surgical and medical procedures
    Surgery/intra-operative injury
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    (prolonged) hospitalisation
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Death
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Life threatening
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    6
    Other
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    32 / 55 (58.18%)
    29 / 54 (53.70%)
         occurrences all number
    58
    63
    Pain
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    14 / 55 (25.45%)
    19 / 54 (35.19%)
         occurrences all number
    24
    39
    Secondary malignancy
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Severe/permanent disability
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Syndromes
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Sexual/reproductive function
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    5 / 54 (9.26%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/upper respiratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    7 / 55 (12.73%)
    5 / 54 (9.26%)
         occurrences all number
    17
    5
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 55 (5.45%)
    11 / 54 (20.37%)
         occurrences all number
    3
    13
    Blood and lymphatic system disorders
    Blood/bone marrow
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    12 / 55 (21.82%)
    8 / 54 (14.81%)
         occurrences all number
    19
    12
    Hemorrhage/bleeding
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 55 (1.82%)
    12 / 54 (22.22%)
         occurrences all number
    1
    17
    Lymphatics
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    13 / 55 (23.64%)
    14 / 54 (25.93%)
         occurrences all number
    19
    28
    Eye disorders
    Ocular/visual
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    13 / 55 (23.64%)
    8 / 54 (14.81%)
         occurrences all number
    26
    10
    Gastrointestinal disorders
    GI
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    26 / 55 (47.27%)
    18 / 54 (33.33%)
         occurrences all number
    73
    32
    Hepatobiliary disorders
    Hepatobiliary/pancreas
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Dermatology/skin
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    14 / 55 (25.45%)
    8 / 54 (14.81%)
         occurrences all number
    20
    10
    Renal and urinary disorders
    Renal/genitourinary
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 54 (1.85%)
         occurrences all number
    7
    1
    Endocrine disorders
    Endocrine
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 54 (5.56%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Musculoskeletal/soft tissue
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    19 / 55 (34.55%)
    10 / 54 (18.52%)
         occurrences all number
    33
    15
    Infections and infestations
    Infections
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    21 / 55 (38.18%)
    35 / 54 (64.81%)
         occurrences all number
    39
    58
    Metabolism and nutrition disorders
    Metabolic/laboratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    4 / 55 (7.27%)
    9 / 54 (16.67%)
         occurrences all number
    6
    12

    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
    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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