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    Clinical Trial Results:
    INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR INFANTS UNDER ONE YEAR WITH ACUTE LYMPHOBLASTIC OR BIPHENOTYPIC LEUKEMIA

    Summary
    EudraCT number
    		 2005-004599-19
    Trial protocol
    		 IT   BE   FR   DE   GB   AT   PT   DK   IE  
    Global end of trial date
    01 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2024
    First version publication date
    29 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INTERFANT-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00550992
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DCOG
    Sponsor organisation address
    Heidelberglaan 25, Utrecht, Netherlands, 3584 CS
    Public contact
    Prof. dr. R. Pieters, DCOG, +31 889727272, r.pieters@prinsesmaximacentrum.nl
    Scientific contact
    Prof. dr. R. Pieters, DCOG, +31 889727272, r.pieters@prinsesmaximacentrum.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
    01 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the role of an early intensification of two `AML` induction blocks versus protocol Ib directly after induction, in a randomized way in MR and HR patients
    Protection of trial subjects
    Parents signed informed consent; trial conducted according to ICH GCP and declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 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
    Australia: 41
    Country: Number of subjects enrolled
    Portugal: 29
    Country: Number of subjects enrolled
    United Kingdom: 83
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 64
    Country: Number of subjects enrolled
    Denmark: 26
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 78
    Country: Number of subjects enrolled
    Italy: 62
    Country: Number of subjects enrolled
    Netherlands: 35
    Country: Number of subjects enrolled
    Argentina: 52
    Country: Number of subjects enrolled
    Hong Kong: 16
    Country: Number of subjects enrolled
    Chile: 36
    Country: Number of subjects enrolled
    United States: 31
    Country: Number of subjects enrolled
    Poland: 55
    Country: Number of subjects enrolled
    Canada: 4
    Worldwide total number of subjects
    651
    EEA total number of subjects
    388
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    137
    Infants and toddlers (28 days-23 months)
    514
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from February 2006 to July 2016. Individual study groups obtained ethics approval and physicians obtained informed consent from parents. Eligibility criteria were a diagnosis of ALL (except those with a mature B phenotype), age 365 days or younger, and no prior antileukemic therapy other than emergency treatment.

    Pre-assignment
    Screening details
    		 All infants diagnosed with ALL

    Period 1
    Period 1 title
    Randomzed Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    n.a.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Protocol 1b
    Arm description
    		 Standard of Care
    Arm type
    		 SOC

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ADE+MAE
    Arm description
    		 experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AraC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m2 BID IV for 10 days during ADE and MAE course

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/m2 per day on days 1, 3 and 5 during ADE course

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m2 per day for 5 days during ADE and MAE course

    Investigational medicinal product name
    mitoxantrone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    12 mg/m2 per day on day 1, 3 and 5 of MAE course

    Number of subjects in period 1 [1]
    		Protocol 1b ADE+MAE
    Started
    161
    169
    Completed
    161
    169
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Total number of registered patients is 651; number of patients eligible for randomization and randomized is 330

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Protocol 1b
    Reporting group description
    		 Standard of Care

    Reporting group title
    ADE+MAE
    Reporting group description
    		 experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE)

    Reporting group values
    		 Protocol 1b ADE+MAE Total
    Number of subjects
    		 161 169 330
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 43 41 84
        Infants and toddlers (28 days-23 months)
    		 118 128 246
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 61 69 130
        Male
    		 100 100 200

    End points

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    End points reporting groups
    Reporting group title
    Protocol 1b
    Reporting group description
    		 Standard of Care

    Reporting group title
    ADE+MAE
    Reporting group description
    		 experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE)

    Primary: 3-year Disease Free Survival rate

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    End point title
    		 3-year Disease Free Survival rate [1]
    End point description
    DFS, the primary end point, was defined as time from random assignment to relapse, death in continuous complete remission from any cause, or second malignant neoplasm, whichever occurred first.
    End point type
    Primary
    End point timeframe
    DFS, the primary end point, was defined as time from random assignment to relapse, death in continuous complete remission from any cause, or second malignant neoplasm, whichever occurred first.
    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: Descriptive statistics
    End point values
    		 Protocol 1b ADE+MAE
    Number of subjects analysed
    161
    169
    Units: percentage
    39
    45
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6-year follow-up
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Protocol 1b
    Reporting group description
    		 Standard of Care

    Reporting group title
    ADE+MAE
    Reporting group description
    		 experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE)

    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: We refer to the article added in the section More Information
    Serious adverse events
    		 Protocol 1b ADE+MAE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 161 (8.07%)
    17 / 169 (10.06%)
         number of deaths (all causes)
    13
    17
         number of deaths resulting from adverse events
    13
    17
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    13 / 161 (8.07%)
    17 / 169 (10.06%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 17
         deaths causally related to treatment / all
    0 / 13
    0 / 17
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Protocol 1b ADE+MAE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 169 (0.00%)

    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/31283407
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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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