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    Clinical Trial Results:
    Evaluation of Efficacy and Toxicity of Intensified Consolidation Therapy in AML Patients ≥60 Years

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2007-005806-29
    Trial protocol
    		 AT  
    Global end of trial date
    21 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2016
    First version publication date
    22 Apr 2016
    Other versions
    Summary report(s)
    		 Report final 18.12.2015

    Trial information

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    Trial identification
    Sponsor protocol code
    AKH-AML-0108
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Medizinische Universität Wien Klinik für Innere Medizin I Abt. für Hämatologie & Hämostaseologie, Medizinische Universität Wien Klinik für Innere Medizin I Abt. für Hämatologie & Hämostaseologie, +43 14040045220, susanne.herndlhofer@meduniwien.ac.at
    Scientific contact
    Medizinische Universität Wien Klinik für Innere Medizin I Abt. für Hämatologie & Hämostaseologie, Medizinische Universität Wien Klinik für Innere Medizin I Abt. für Hämatologie & Hämostaseologie, +43 14040045220, wolfgang.r.sperr@meduniwien.ac.at
    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
    21 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Tolerability (number of cycles of consolidation therapy; toxicity) of intensified consolidation therapy in elderly AML patients Adverse event profile
    Protection of trial subjects
    The trial was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jul 2008
    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
    Austria: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    17
    From 65 to 84 years
    46
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the participating centers located in Austria i.e. Medical Univerity of Vienna, Hospital Hietzing, Hospidal of the Elisabethinen Linz, Kaiser Franz Josef Hospidal Vienna, Donauspital Vienna between 17.07.2008 and 21.1.2015

    Pre-assignment
    Screening details
    		 All patients diagnosed with "de novo" AML aged ≥60 years eligible for intensive chemotherapy were screened

    Pre-assignment period milestones
    Number of subjects started
    		 64
    Number of subjects completed
    		 64

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    45mg/m², day 1-3 of Induction 1

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m², day 1-5 of Induction 1

    Investigational medicinal product name
    Cytarabin
    Investigational medicinal product code
    Other name
    ARA-C
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m², days 1-7 of Induction 1; 2000mg/m², days 1-5 of Induction 3 and Consolidation 1, 2000mg/m², days 1, 3, 5 of Induction 2 and Consolidation 2, 3, and 4

    Investigational medicinal product name
    Mitoxantrone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    12 mg/m² on days 3, 5 of Induction 2

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m² on days 1-5 of Induction 3 and Consolidation 1

    Investigational medicinal product name
    Pegfilgrastim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6mg on the first day after chemotherapy

    Number of subjects in period 1
    		Treatment
    Started
    64
    Completed
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 64 64
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 17 17
        From 65-84 years
    		 46 46
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 69.9 (60.1 to 85.2) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 39 39
    Subject analysis sets

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients included in the study from start of chemotherapy to the end of follow up

    Subject analysis sets values
    		 Overall
    Number of subjects
    64
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    17
        From 65-84 years
    46
        85 years and over
    1
    Age continuous
    Units: years
        median (full range (min-max))
    69.9 (60.1 to 85.2)
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    39

    End points

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

    Subject analysis set title
    Overall
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients included in the study from start of chemotherapy to the end of follow up

    Primary: AEs Consolidation 1

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    End point title
    		 AEs Consolidation 1 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Consolidation 1
    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: Because of the early termination, we only used descriptive statistical methods to describe the results of this trial.
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Primary: AEs Consolidation 2

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    End point title
    		 AEs Consolidation 2 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Consolidation 2
    Notes
    [2] - 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: Because of the early termination, we only used descriptive statistical methods to describe the results of this trial.
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Primary: AEs Consolidation 3

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    End point title
    		 AEs Consolidation 3 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Consolidation 3
    Notes
    [3] - 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: Because of the early termination, we only used descriptive statistical methods to describe the results of this trial.
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Primary: AEs Consolidation 4

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    End point title
    		 AEs Consolidation 4 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Consolidation 4
    Notes
    [4] - 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: Because of the early termination, we only used descriptive statistical methods to describe the results of this trial.
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Continuous complete remission

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    End point title
    		 Continuous complete remission
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: CR rate

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    End point title
    		 CR rate
    End point description
    End point type
    Secondary
    End point timeframe
    Induction phase
    End point values
    Number of subjects analysed
    Units: number
    No statistical analyses for this end point

    Secondary: Relapse rate

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    End point title
    		 Relapse rate
    End point description
    End point type
    Secondary
    End point timeframe
    Study Period
    End point values
    		 Treatment
    Number of subjects analysed
    43
    Units: number
    25
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 Treatment
    Number of subjects analysed
    64
    Units: number
        median (full range (min-max))
    1.1 (0 to 5.9)
    No statistical analyses for this end point

    Secondary: Continuous complete remission

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    End point title
    		 Continuous complete remission
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 Treatment
    Number of subjects analysed
    39
    Units: number
        median (full range (min-max))
    1.23 (0.15 to 5.85)
    No statistical analyses for this end point

    Secondary: Disease free survival

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    End point title
    		 Disease free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 Treatment
    Number of subjects analysed
    39
    Units: number
        median (full range (min-max))
    1.23 (0.15 to 5.85)
    No statistical analyses for this end point

    Secondary: Duration of neutropenia Consolidation 1

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    End point title
    		 Duration of neutropenia Consolidation 1
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 1
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of neutropenia Consolidation 2

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    End point title
    		 Duration of neutropenia Consolidation 2
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 2
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of neutropenia Consolidation 3

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    End point title
    		 Duration of neutropenia Consolidation 3
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 3
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of neutropenia Consolidation 4

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    End point title
    		 Duration of neutropenia Consolidation 4
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 4
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of hospitalisation Consolidation 1

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    End point title
    		 Duration of hospitalisation Consolidation 1
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 1
    End point values
    Number of subjects analysed
    Units: number
        least squares mean (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of hospitalisation Consolidation 2

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    End point title
    		 Duration of hospitalisation Consolidation 2
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 2
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of hospitalisation Consolidation 3

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    End point title
    		 Duration of hospitalisation Consolidation 3
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 3
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Duration of hospitalisation Consolidation 4

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    End point title
    		 Duration of hospitalisation Consolidation 4
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 4
    End point values
    Number of subjects analysed
    Units: number
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: GCS-F levels detectable up to day 14

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    End point title
    		 GCS-F levels detectable up to day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Consolidation 1
    End point values
    Number of subjects analysed
    Units: ng/ml
        median (full range (min-max))
    No statistical analyses for this end point

    Secondary: Age

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    End point title
    		 Age
    End point description
    End point type
    Secondary
    End point timeframe
    Study period
    End point values
    		 Treatment
    Number of subjects analysed
    64
    Units: years
        median (full range (min-max))
    69.9 (60.1 to 85.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 64 (42.19%)
         number of deaths (all causes)
    15
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nervous system disorders
    Central nervous system haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dementia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Disease progression
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Multi-organ failure
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Pyrexia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Diffuse alveolar damage
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Internal haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Haematinuria
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Aspergilloma
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Febrile infection
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    3 / 64 (4.69%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    Pneumonia
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    1 / 1
    Septic shock
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 64 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    9
    Hypertension
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    5
    Hypotension
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Phlebitis
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 64 (26.56%)
         occurrences all number
    23
    Mucosal inflammation
         subjects affected / exposed
    21 / 64 (32.81%)
         occurrences all number
    30
    Oedema
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Oedema peripheral
         subjects affected / exposed
    18 / 64 (28.13%)
         occurrences all number
    24
    Pain assessment
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    7
    Peripheral swelling
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    13 / 64 (20.31%)
         occurrences all number
    18
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 64 (23.44%)
         occurrences all number
    15
    Dyspnoea
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    15 / 64 (23.44%)
         occurrences all number
    21
    Oropharyngeal pain
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    7
    Pleural effusion
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    7
    Psychiatric disorders
    Depression
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Insomnia
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    14
    Investigations
    C-reactive protein
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Injury, poisoning and procedural complications
    Allergic transfusion reaction
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    9
    Fall
         subjects affected / exposed
    11 / 64 (17.19%)
         occurrences all number
    11
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 64 (28.13%)
         occurrences all number
    30
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    56 / 64 (87.50%)
         occurrences all number
    134
    Neutropenia
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    8
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    23 / 64 (35.94%)
         occurrences all number
    35
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Abdominal pain upper
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    11 / 64 (17.19%)
         occurrences all number
    15
    Diarrhoea haemorrhagic
         subjects affected / exposed
    13 / 64 (20.31%)
         occurrences all number
    18
    Haemorrhoids
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    33 / 64 (51.56%)
         occurrences all number
    76
    Vomiting
         subjects affected / exposed
    13 / 64 (20.31%)
         occurrences all number
    22
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Petechiae
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    11
    Rash
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Cytarabine syndrome
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    18
    Musculoskeletal pain
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    5
    Neck pain
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Pain in extremity
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    8
    Infections and infestations
    Candida infection
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Conjunctivitis
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    5
    Diarrhoea infectious
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    23
    Febrile infection
         subjects affected / exposed
    11 / 64 (17.19%)
         occurrences all number
    11
    Folliculitis
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    5
    Herpes virus infection
         subjects affected / exposed
    17 / 64 (26.56%)
         occurrences all number
    22
    Infection
         subjects affected / exposed
    37 / 64 (57.81%)
         occurrences all number
    78
    Oral herpes
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    14
    Pneumonia
         subjects affected / exposed
    19 / 64 (29.69%)
         occurrences all number
    21
    Urinary tract infection
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Fluid retention
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Dec 2009
    Following substantials changes have been done: AEs have to be graded according to NCI CTC V3.0 Standardisation of prognostic factors over all sections Standardisation of secondary objectives over all sections Febrile neutropenia was defined as Fever >=38°C and ANC < 0.5G/L Analysing of KIT Mutation was added to the SCR procedure AML related findings were added to the SCR procedure HLA Typing was added to the SCR procedure Charlson Score moved from Induction 1 to the SCR visit Secondary objectives were deleted in section 10.1 MeDRA coding was added to the endpoints Wilcoxon signed rank test was added instead of Wilcoxon test (paired data) Typing errors were corrected Administration of Peg-Filgrastim in Induction 1 -3 at the discretion of the Principal Investigator Changes in the follow up period Mitoxantron was changed to Mitoxanthrone Daunorubicine was changed to Daunorubicin Change from „over“ three hours to „for“ three hours Change from „Seite“ to „page“
    30 Sep 2014
    Following substantials changes have been done: Contact data have been changed from +43 1 40400 6085, Fax: +43 1 40400 4030 to Tel.: +43 1 40400 60850, Fax: +43 1 40400 40300 ANC <500 cells/µL has been changed to ANC <500 cells/µL or WBC < 1000 cells/µL (if ANC is not available) Follow up period has been changed from „In case of presence of a molecular marker, monitoring of this marker in the bm during the first 2 years after CR (in 3 months interval) Source data related to the follow up and follow up events will be documented in each center and will be collected and analyzed centrally (after recalling from centers) after 1, 3, and 5 years. Follow up should be performed 1 month after the end of treatment visit, and in an interval of 6 weeks or shorter for one year after the first follow up visit“ to „In case of presence of a molecular marker, monitoring of this marker in the bm during the first 2 years after CR (in 6 months interval) Source data related to the follow up and follow up events will be documented in each center and will be collected and analyzed centrally (after recalling from centers) after 1, 3, and 5 years or until 15. Sep. 2014, whatever comes first. Follow up should be performed 1 month after end of treatment and in a six-week interval within the first year, thereafter at least every 6 months until 15. Sep. 2014“ Section 9.2. has been amended: Inclusion of the sentence „The case report form (CRF) pages containing adverse event reporting by investigator, e.g. start date, stop date, frequency, severity, study relation and action taken for this event will serve as the source data.“

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Jan 2015
    On 21 January 2015 the clinical trial was prematurely terminated because of an extremly slow recruitment despite an already long recruitment period. It could not be expected that the planned number of subjects, who finished the trial acoording to the protocol, could be reached in a predicatble time period.There are a number of possible implications for the interpretation of the study because of these changes. Primarily because of the early termination not all planned endpoints – especially secondary - can be answered. Moreover, the statistical power of the results is markedly reduced. In case of no significant results, it cannot be excluded that these data would have become significant in case the total number of planned patients would have been included. On the other hand, borderline significant results are more questionable.
    -

    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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