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    Clinical Trial Results:
    A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.

    Summary
    EudraCT number
    		 2006-001777-19
    Trial protocol
    		 NL   BE  
    Global end of trial date
    31 Oct 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON 81 AML
    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 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) 2. To assess in a randomized comparison the effect of bevacizumab on the CR rate.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2007
    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: 138
    Country: Number of subjects enrolled
    Belgium: 40
    Country: Number of subjects enrolled
    Switzerland: 41
    Worldwide total number of subjects
    219
    EEA total number of subjects
    178
    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)
    75
    From 65 to 84 years
    144
    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
    		 Control Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dauno
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Dauno 45mg/m2 3hrs infusion day 1,2,3

    Investigational medicinal product name
    Cytarabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Cytarabin 200 mg/m2 24hr cont. Infusion, day 1-7, cycle 1 Cytarabin 1000 mg/m2 6hr infusion q 12hr x 12 day 1-6 cycle 2

    Arm title
    		 Experimental Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dauno
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Dauno 45mg/m2 3hrs infusion day 1,2,3

    Investigational medicinal product name
    Cytarabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Cytarabin 200 mg/m2 24hr cont. Infusion, day 1-7, cycle 1 Cytarabin 1000 mg/m2 6hr infusion q 12hr x 12 day 1-6 cycle 2

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    5 or 10mg/kg, 1,5hr infusion day 1, 15 cycle 1 and 2

    Number of subjects in period 1
    		Control Group Experimental Group
    Started
    110
    109
    Completed
    73
    65
    Not completed
    37
    44
         Adverse reactions
    5
    12
         Other
    9
    5
         At patient's request
    2
    2
         Lack of efficacy
    21
    25

    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
    		 219 219
    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)
    		 75 75
        From 65-84 years
    		 144 144
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (60 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 104 104
        Male
    		 115 115

    End points

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

    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
    		 Control Group Experimental Group
    Number of subjects analysed
    85
    86
    Units: Whole
    85
    86
    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
    All AEs of Grade 2 or higher, with the exception of progression of disease, occurring during the protocol treatment period will be reported. 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
    Control Group
    Reporting group description
    		 -

    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Serious adverse events
    		 Control Group Experimental Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 109 (33.94%)
    60 / 105 (57.14%)
         number of deaths (all causes)
    97
    97
         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
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    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 / 109 (1.83%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    9 / 109 (8.26%)
    7 / 105 (6.67%)
         occurrences causally related to treatment / all
    7 / 9
    4 / 7
         deaths causally related to treatment / all
    3 / 4
    1 / 2
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    9 / 109 (8.26%)
    14 / 105 (13.33%)
         occurrences causally related to treatment / all
    3 / 9
    11 / 16
         deaths causally related to treatment / all
    0 / 3
    2 / 3
    Nervous system disorders
    Nervous system disorder
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    4 / 109 (3.67%)
    9 / 105 (8.57%)
         occurrences causally related to treatment / all
    2 / 4
    5 / 9
         deaths causally related to treatment / all
    0 / 1
    2 / 4
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 109 (1.83%)
    9 / 105 (8.57%)
         occurrences causally related to treatment / all
    2 / 2
    8 / 9
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 109 (0.92%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    2 / 109 (1.83%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    11 / 109 (10.09%)
    23 / 105 (21.90%)
         occurrences causally related to treatment / all
    6 / 11
    16 / 23
         deaths causally related to treatment / all
    4 / 8
    10 / 12
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Group Experimental Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 109 (97.25%)
    103 / 105 (98.10%)
    Vascular disorders
    Vascular
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    12 / 109 (11.01%)
    10 / 105 (9.52%)
         occurrences all number
    12
    12
    General disorders and administration site conditions
    Constitutional symptoms
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    22 / 109 (20.18%)
    25 / 105 (23.81%)
         occurrences all number
    29
    37
    Growth and development
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 105 (0.95%)
         occurrences all number
    0
    1
    Pain
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    24 / 109 (22.02%)
    17 / 105 (16.19%)
         occurrences all number
    30
    26
    Syndromes
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 109 (2.75%)
    2 / 105 (1.90%)
         occurrences all number
    3
    2
    Immune system disorders
    Allergy/immunology
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    14 / 109 (12.84%)
    7 / 105 (6.67%)
         occurrences all number
    16
    9
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/upper respiratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    22 / 109 (20.18%)
    28 / 105 (26.67%)
         occurrences all number
    25
    41
    Cardiac disorders
    Cardiac arrythmia
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 109 (8.26%)
    9 / 105 (8.57%)
         occurrences all number
    9
    9
    Cardiac general
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    13 / 109 (11.93%)
    29 / 105 (27.62%)
         occurrences all number
    14
    37
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    20 / 109 (18.35%)
    27 / 105 (25.71%)
         occurrences all number
    27
    34
    Blood and lymphatic system disorders
    Blood/bone marrow
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    7 / 109 (6.42%)
    3 / 105 (2.86%)
         occurrences all number
    7
    3
    Coagulation
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 109 (8.26%)
    4 / 105 (3.81%)
         occurrences all number
    10
    4
    Hemorrhage/bleeding
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    15 / 109 (13.76%)
    25 / 105 (23.81%)
         occurrences all number
    26
    38
    Lymphatics
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    10 / 109 (9.17%)
    7 / 105 (6.67%)
         occurrences all number
    14
    7
    Ear and labyrinth disorders
    Auditory/ear
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 109 (2.75%)
    2 / 105 (1.90%)
         occurrences all number
    4
    2
    Eye disorders
    Ocular/visual
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    8 / 109 (7.34%)
    8 / 105 (7.62%)
         occurrences all number
    8
    8
    Gastrointestinal disorders
    Gastrointestinal
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    74 / 109 (67.89%)
    75 / 105 (71.43%)
         occurrences all number
    152
    170
    Hepatobiliary disorders
    Hepatobiliary/pancreas
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 105 (1.90%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Dermatology/skin
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    66 / 109 (60.55%)
    52 / 105 (49.52%)
         occurrences all number
    105
    73
    Renal and urinary disorders
    Renal/genitourinary
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 109 (8.26%)
    11 / 105 (10.48%)
         occurrences all number
    10
    14
    Endocrine disorders
    Endocrine
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    0 / 109 (0.00%)
    3 / 105 (2.86%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Musculoskeletal/soft tissue
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    5 / 109 (4.59%)
    5 / 105 (4.76%)
         occurrences all number
    6
    5
    Infections and infestations
    Infection
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    92 / 109 (84.40%)
    95 / 105 (90.48%)
         occurrences all number
    260
    285
    Metabolism and nutrition disorders
    Metabolic/laboratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    45 / 109 (41.28%)
    39 / 105 (37.14%)
         occurrences all number
    109
    145

    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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