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    Clinical Trial Results:
    A double-blind, placebo-controlled, randomized, multi-center phase II trial to assess the efficacy of Sorafenib added to standard primary therapy in patients with newly diagnosed AML ≤ 60 years of age

    Summary
    EudraCT number
    		 2008-004968-40
    Trial protocol
    		 DE  
    Global end of trial date
    25 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2021
    First version publication date
    09 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TUD-SORAML-034
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00893373
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität Dresden
    Sponsor organisation address
    Mommsenstr. 9, Dresden, Germany,
    Public contact
    MK1, Klinische Studien, Universitätsklinikum Dresden, 0049 03514583775, christoph.roellig@uniklinikum-dresden.de
    Scientific contact
    MK1, Klinische Studien, Universitätsklinikum Dresden, 0049 03514583775, christoph.roellig@uniklinikum-dresden.de
    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
    20 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to compare the median Event Free Survival (EFS) of AML patients in the age of ≥18 and ≤ 60 years between the Sorafenib and the control group
    Protection of trial subjects
    In the responsibility of the investigator, subjects were closely monitored during this study. Via the safety desk, the coordinating investigator on behalf of the sponsor reviewed all reported SAEs for reasonable suspected causal relationship to the investigational treatment and for expectedness in terms of nature and severity of an SAR in relation to the applicable sorafenib product information or investigator’s brochure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 78 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 276
    Worldwide total number of subjects
    276
    EEA total number of subjects
    276
    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)
    276
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients aged 18 to 60 years with newly diagnosed de-novo or secondary acute myeloid leukaemia according to WHO criteria, with a clinical performance score of 0–2 and adequate renal and liver function, were eligible for inclusion. Between March 27, 2009, and Nov 28, 2011, 276 patients were enrolled and randomised

    Pre-assignment
    Screening details
    		 Pretreatment evaluations were done to determine the patients eligibility for the study within 10 days prio to the first course of induction therapy.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm V (Sorafenib)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sorafenib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    double induction: sorafenib 800mg/day (2 tablets twice a day) from day 10 continuously until day 19 alternative induction therapy - HAM (in the case of insufficient response to induction therapy I): sorafenib 800mg/day (2 tablets twice a day) from day 10 continuously until day 19 three cycles of consolidation: sorafenib 800mg/day (2 tablets twice a day) from day 8 continuously until 3 days before first day of next chemotherapy course Maintenance: sorafenib 800mg/day (2 tablets twice a day) started on day 8 of the last consolidation cycle; Maintenance therapy was administered continuously until one year after start of maintenance therapy. 

    Arm title
    		 Arm P (Placebo)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    double induction: Placebo (2 tablets twice a day) from day 10 continuously until day 19 alternative induction therapy - HAM (in the case of insufficient response to induction therapy I): Placebo (2 tablets twice a day) from day 10 continuously until day 19 three cycles of consolidation: Placebo (2 tablets twice a day) from day 8 continuously until 3 days before first day of next chemotherapy course Maintenance: Placebo (2 tablets twice a day) started on day 8 of the last consolidation cycle; Maintenance therapy was administered continuously until one year after start of maintenance therapy. 

    Number of subjects in period 1
    		Arm V (Sorafenib) Arm P (Placebo)
    Started
    138
    138
    Completed
    134
    133
    Not completed
    4
    5
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    2
         second malignancy
    -
    1
         no AML
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm V (Sorafenib)
    Reporting group description
    		 -

    Reporting group title
    Arm P (Placebo)
    Reporting group description
    		 -

    Reporting group values
    		 Arm V (Sorafenib) Arm P (Placebo) Total
    Number of subjects
    		 138 138 276
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 138 138 276
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 66 71 137
        Male
    		 72 67 139

    End points

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    End points reporting groups
    Reporting group title
    Arm V (Sorafenib)
    Reporting group description
    		 -

    Reporting group title
    Arm P (Placebo)
    Reporting group description
    		 -

    Primary: event-free survival

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    End point title
    		 event-free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint was event-free survival, with an event defined as either primary treatment failure or relapse or death, assessed in all randomised patients who received at least one dose of study treatment.
    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: further information can be found in the publication (see online references)
    End point values
    		 Arm V (Sorafenib) Arm P (Placebo)
    Number of subjects analysed
    134
    133
    Units: months
        median (confidence interval 95%)
    21 (9 to 32)
    9 (4 to 15)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs and SAEs had to be recorded from the time the informed consent is signed, up to and including 30 days following last administration of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: further information can be found in the publication (see online references)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26549589
    http://www.ncbi.nlm.nih.gov/pubmed/33603142
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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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