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    Clinical Trial Results:
    A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia

    Summary
    EudraCT number
    		 2015-001151-68
    Trial protocol
    		 DE   FR   NL   BE   ES   IT  
    Global end of trial date
    21 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2026
    First version publication date
    12 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TUD-APOLLO-064
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02688140
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität Dresden
    Sponsor organisation address
    Helmholtzstraße 10, Dresden, Germany, 01069
    Public contact
    Coordinating investigator, Technische Universität Dresden, Coordinating investigator, MK1, Bereich Klinische Studien, +49 3514583192, uwe.platzbecker@ukdd.de
    Scientific contact
    Coordinating investigator, Technische Universität Dresden, Coordinating investigator, MK1, Bereich Klinische Studien, +49 +493514583192, uwe.platzbecker@ukdd.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
    05 Mar 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen) in newly diagnosed high-risk APL
    Protection of trial subjects
    An independent Data safety monitoring board (DSMB) was set in order to oversee the safety of the trial subjects by periodic safety assessments of the trial therapy . The DSMB followed specific guidelines outlined in the DSMB charter.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 33
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Italy: 35
    Worldwide total number of subjects
    133
    EEA total number of subjects
    133
    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)
    133
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with newly diagnosed high-risk acute promyelocytic leukemia (APL/AML M3) at the age of 18 to 65.

    Pre-assignment
    Screening details
    		 Assessments from routine diagnostic procedures (before informed consent) could be used for Baseline visit: Assessments (internal or external) of ECG, echocardiography, hepatitis- and HIV serology should not be older than 14 days before randomization. Bone morrow assessments (internal or external) should not be older than 7 days before randomization

    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
    		 Experimental Arm A (ATRA/ATO)
    Arm description
    		 All-trans retinoic acid and arsenic trioxide (ATRA/ATO) preceded by two doses of idarubicin and followed by four ATRA/ATO consolidation cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trisenox
    Investigational medicinal product code
    Other name
    arsenic trioxide
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy ATO Dose: 0.15 mg/kg body weight Duration: day 5-28 max. up to day 60 after start of IDA Consolidation cycles I-IV ATO Dose: 0.15 mg/kg body weight Duration: day 1-5 (4wks on/ 4wks off for a total of 4 courses)

    Arm title
    		 Control Arm B (AIDA regimen)
    Arm description
    		 ATRA plus idarubicin induction followed by three chemotherapy consolidation cycles and two years of maintenance
    Arm type
    		 standard chemotherapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Experimental Arm A (ATRA/ATO) Control Arm B (AIDA regimen)
    Started
    68
    65
    Completed
    62
    50
    Not completed
    6
    15
         Adverse event, serious fatal
    5
    5
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    7
         Medical decision
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental Arm A (ATRA/ATO)
    Reporting group description
    		 All-trans retinoic acid and arsenic trioxide (ATRA/ATO) preceded by two doses of idarubicin and followed by four ATRA/ATO consolidation cycles

    Reporting group title
    Control Arm B (AIDA regimen)
    Reporting group description
    		 ATRA plus idarubicin induction followed by three chemotherapy consolidation cycles and two years of maintenance

    Reporting group values
    		 Experimental Arm A (ATRA/ATO) Control Arm B (AIDA regimen) Total
    Number of subjects
    		 68 65 133
    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)
    		 68 65 133
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 34 30 64
        Male
    		 34 35 69

    End points

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    End points reporting groups
    Reporting group title
    Experimental Arm A (ATRA/ATO)
    Reporting group description
    		 All-trans retinoic acid and arsenic trioxide (ATRA/ATO) preceded by two doses of idarubicin and followed by four ATRA/ATO consolidation cycles

    Reporting group title
    Control Arm B (AIDA regimen)
    Reporting group description
    		 ATRA plus idarubicin induction followed by three chemotherapy consolidation cycles and two years of maintenance

    Primary: Event-free survival (EFS)

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    End point title
    		 Event-free survival (EFS) [1]
    End point description
    To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).
    End point type
    Primary
    End point timeframe
    2-year event-free survival
    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
    		 Experimental Arm A (ATRA/ATO) Control Arm B (AIDA regimen)
    Number of subjects analysed
    68
    65
    Units: percent
        number (confidence interval 95%)
    88 (81 to 96)
    73 (63 to 85)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the trial all adverse events CTCAE ≥ grade 3 have been documented in the eCRF. AEs needed to be documented from the date of randomisation until 28 days after the date of study termination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    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? Yes
    Date
    Amendment
    11 Jun 2018
    France: protocol version 2.2 F, 11.06.2018
    26 Sep 2019
    France: Final trial protocol version 2.3 F, 26.09.2019
    09 Jul 2021
    Spain: Final trial protocol version 4.0 F, 09.07.2021

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Jan 2019
    Recruitment of new patients was suspended due to supply issues with the investigational medicinal product. Start in the Netherlands: 07.01.2019, Restart: 04.10.2019 Start in Belgium: 07.01.2019, Restart: 18.11.2019 Start in Germany: 05.02.2019, Restart: 08.10.2019 Start in France: 05.02.2019, Restart: 04.10.2019 Start in Italy: 05.02.2019; Restart: 24.02.2020
    04 Oct 2019

    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/40825164
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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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