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    Clinical Trial Results:
    Etude multicentrique de phase III randomisée ouverte testant l’efficacité du gemtuzumab ozogamycin (MYLOTARG®) en association avec la chimiothérapie intensive chez les patients de 18 à 60 ans atteints de leucémie aiguë myéloblastique (LAM) avec cytogénétique intermédiaire.

    Summary
    EudraCT number
    		 2007-001209-64
    Trial protocol
    		 FR  
    Global end of trial date
    26 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2019
    First version publication date
    17 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BRD 06/10-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00860639
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Nantes
    Sponsor organisation address
    5 allée de l'Ile Gloriette, Nantes, France, 44093
    Public contact
    Pr MOREAU, CHU Nantes, philippe.moreau@chu-nantes.fr
    Scientific contact
    Pr MOREAU, CHU Nantes, philippe.moreau@chu-nantes.fr
    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
    09 Jul 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Démontrer la supériorité de l’addition de gemtuzumab ozogamycin (Mylotarg®) à la chimiothérapie d’induction et de consolidation vs chimiothérapie seule en terme de survie sans évènement (event free survival : EFS) pour les patients âgés de 18 à 60 ans présentant une LAM avec cytogénétique intermédiaire non éligibles pour une allogreffe standard.
    Protection of trial subjects
    Very close follow-up of the patients with biological analysis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2007
    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
    France: 327
    Worldwide total number of subjects
    327
    EEA total number of subjects
    327
    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)
    327
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Intermediate acute leukaemia

    Period 1
    Period 1 title
    First step
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day continuous infusion, D1, D2, D3, D4, D5, D6, D7 - Mylotarg® : 6 mg/m² via slow IV route for 2 hours on D4 - Premedication is required consisting of paracetamol 1g associated with an antihistamine : Dexchlorpheniramine 5 mg (Polaramine®) one hour before starting Mylotarg® - Monitoring during infusion should include blood pressure and heart beat readings every 15 minutes for the first hour and subsequently every 30 minutes for 3 hours. Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5 - Mylotarg® : 6 mg/ m2 via slow IV route for 2 hours on D4 
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mylotarg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/m² via slow IV route for 2 hours on D4

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg / m²/ day slow IV for 15 minutes at D1, D2, D3

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Induction course : 200 mg / m²/ day, continuous infusion at D1, D2, D3, D4, D5, D6, D7 - Consolidation course : 1 g / m² x 2 / day via IV infusion for 3 hours at D1, D2, D3, D4, D5

    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/ day slow IV for 15 minutes at D1, D2

    Arm title
    		 Arm B
    Arm description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day, continuous infusion, D1, D2, D3, D4, D5, D6, D7 Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg / m²/ day slow IV for 15 minutes at D1, D2, D3

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Induction course : 200 mg / m²/ day, continuous infusion at D1, D2, D3, D4, D5, D6, D7 - Consolidation course : 1 g / m² x 2 / day via IV infusion for 3 hours at D1, D2, D3, D4, D5

    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/ day slow IV for 15 minutes at D1, D2

    Number of subjects in period 1 [1]
    		Arm A Arm B
    Started
    119
    119
    Completed
    55
    57
    Not completed
    64
    62
         Premature discontinuation
    64
    62
    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: The difference is due to the fact that the study has 2 periods.
    Period 2
    Period 2 title
    Second step
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable.

    Arms
    Arm title
    		 Arm B
    Arm description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day, continuous infusion, D1, D2, D3, D4, D5, D6, D7 Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg / m²/ day slow IV for 15 minutes at D1, D2, D3

    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/ day slow IV for 15 minutes at D1, D2

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Induction course : 200 mg / m²/ day, continuous infusion at D1, D2, D3, D4, D5, D6, D7 - Consolidation course : 1 g / m² x 2 / day via IV infusion for 3 hours at D1, D2, D3, D4, D5

    Number of subjects in period 2 [2]
    		Arm B
    Started
    73
    Completed
    73
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The difference is due to the fact that the study has 2 periods.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First step
    Reporting group description
    		 -

    Reporting group values
    		 First step Total
    Number of subjects
    		 238 238
    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)
    		 238 238
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 108 108
        Male
    		 130 130

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day continuous infusion, D1, D2, D3, D4, D5, D6, D7 - Mylotarg® : 6 mg/m² via slow IV route for 2 hours on D4 - Premedication is required consisting of paracetamol 1g associated with an antihistamine : Dexchlorpheniramine 5 mg (Polaramine®) one hour before starting Mylotarg® - Monitoring during infusion should include blood pressure and heart beat readings every 15 minutes for the first hour and subsequently every 30 minutes for 3 hours. Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5 - Mylotarg® : 6 mg/ m2 via slow IV route for 2 hours on D4 

    Reporting group title
    Arm B
    Reporting group description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day, continuous infusion, D1, D2, D3, D4, D5, D6, D7 Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5
    Reporting group title
    Arm B
    Reporting group description
    		 Induction course : - Daunorubicin : 60 mg / m²/ day, slow IV for 15 minutes, D1, D2, D3 - Cytarabine : 200 mg / m²/ day, continuous infusion, D1, D2, D3, D4, D5, D6, D7 Consolidation course : - Mitoxantrone : 12 mg / m2/ day, slow IV for 15 minutes, D1, D2 - Cytarabine : 1 g / m2 x 2 / day (every 12 hours) via IV infusion for 3 hours, D1, D2, D3, D4, D5

    Primary: Event-free survival

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    End point title
    		 Event-free survival [1]
    End point description
    Demonstrate the superiority of adding gemtuzumab ozogamycin (Mylotarg®) to induction and consolidation chemotherapy vs chemotherapy alone in terms of event-free survival (EFS) for patients from 18 to 60 years of age presenting AML with intermediate cytogenetics not eligible for a standard allograft.
    End point type
    Primary
    End point timeframe
    3 years
    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: Due to the premature discontinuation of the study, il was impossible to perform the statistical analyses planned in the protocol.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    119 [2]
    119 [3]
    Units: Not applicable
        number (confidence interval 95%)
    45 (38 to 53)
    45 (38 to 53)
    Notes
    [2] - EFS at 3 years on overall population.
    [3] - EFS at 3 years on overall population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signature of the consent form until the end of follow-up for the non-serious adverse events and until resolution for the serious adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Arm B - First and second step
    Reporting group description
    		 -

    Reporting group title
    Arm A
    Reporting group description
    		 -

    Serious adverse events
    		 Arm B - First and second step Arm A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    149 / 192 (77.60%)
    113 / 119 (94.96%)
         number of deaths (all causes)
    91
    56
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms bening and malignant
         subjects affected / exposed
    10 / 192 (5.21%)
    9 / 119 (7.56%)
         occurrences causally related to treatment / all
    3 / 10
    1 / 9
         deaths causally related to treatment / all
    2 / 8
    1 / 8
    Vascular disorders
    Vascular disorder
         subjects affected / exposed
    11 / 192 (5.73%)
    11 / 119 (9.24%)
         occurrences causally related to treatment / all
    5 / 12
    3 / 13
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Surgical and medical procedures
    Lung lobectomy
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorder and administration site conditions
         subjects affected / exposed
    24 / 192 (12.50%)
    24 / 119 (20.17%)
         occurrences causally related to treatment / all
    9 / 35
    3 / 29
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Immune system disorders
    Immune system disorder
         subjects affected / exposed
    10 / 192 (5.21%)
    11 / 119 (9.24%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Reproductive system and breast disorders
    Reproductive system and breast disorder
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 119 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorder
         subjects affected / exposed
    26 / 192 (13.54%)
    10 / 119 (8.40%)
         occurrences causally related to treatment / all
    8 / 33
    5 / 12
         deaths causally related to treatment / all
    2 / 4
    0 / 0
    Psychiatric disorders
    Psychiatric disorder
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigation
         subjects affected / exposed
    5 / 192 (2.60%)
    2 / 119 (1.68%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Poisoning deliberate
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    10 / 192 (5.21%)
    5 / 119 (4.20%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    15 / 192 (7.81%)
    13 / 119 (10.92%)
         occurrences causally related to treatment / all
    4 / 25
    6 / 17
         deaths causally related to treatment / all
    1 / 3
    1 / 1
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    98 / 192 (51.04%)
    86 / 119 (72.27%)
         occurrences causally related to treatment / all
    195 / 269
    160 / 240
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Eye disorders
    Eye disorder
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    14 / 192 (7.29%)
    12 / 119 (10.08%)
         occurrences causally related to treatment / all
    3 / 16
    3 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorder
         subjects affected / exposed
    11 / 192 (5.73%)
    22 / 119 (18.49%)
         occurrences causally related to treatment / all
    6 / 12
    16 / 30
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Skin and subcutaneous tissue disorders
    Rash macular
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorder
         subjects affected / exposed
    7 / 192 (3.65%)
    3 / 119 (2.52%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorder
         subjects affected / exposed
    3 / 192 (1.56%)
    4 / 119 (3.36%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    63 / 192 (32.81%)
    58 / 119 (48.74%)
         occurrences causally related to treatment / all
    33 / 85
    39 / 94
         deaths causally related to treatment / all
    2 / 6
    2 / 5
    Metabolism and nutrition disorders
    Metabolism and nutrition disorder
         subjects affected / exposed
    8 / 192 (4.17%)
    3 / 119 (2.52%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm B - First and second step Arm A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2008
    - Modification of typos on protocol and annexes - Updating of listing of investigators
    04 Mar 2009
    Updating of listing of investigators : addition of 4 news centers, and 5 news centers realizing graft only
    08 Nov 2010
    - Changing the protocol will have more than one treatment arm (arm without Mylotarg®) - Continuation of the ancillary study (resumption of inclusions) - Changing the timing of samples of residual disease (abandonment of post transplant points) and adding a molecular marker.
    16 Nov 2011
    - Resumption of inclusions : temporary stop in april 2009, following DMSC opinion who wanted more analysis about safety. Indeed, after the first intermediary analysis (100 patients), one stop criteria seemed to be reached (rate of death in Mylotarg arm), the DMSC requested a new analysis on the 175 patients included at the time, and a stop of inclusion pending result. After this second analysis, none stop criteria was reached. - Precision on treatment diagram : . SCT advisable in case of RCi after first consolidation . SCT regardless of molecular status for blastic patients at J15, and patient with central nervous disorders at diagnose - Modifications in SAE collection for hematological reaction : only unexpected was collected (than 60 days for induction course, and 45 days for consolidations course).  - - Updating of listing of investigators.
    05 Jul 2012
    - Updating of listing of investigators - Extension of the inclusions period
    06 Feb 2013
    Premature stop inclusions
    07 Feb 2014
    - Updating of listing of investigators (change of principal investigator in Poitiers) - Modification of term monitoring patients
    14 Apr 2014
    - Updating of listing of investigators (change of principal investigator in Colmar) - Modification of expected SAE post graf collection

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Apr 2009
    Temporary stop in april 2009, following DMSC opinion who wanted more analysis about safety. Indeed, after the first intermediary analysis (100 patients), one stop criteria seemed to be reached (rate of death in Mylotarg arm), the DMSC requested a new analysis on the 175 patients included at the time, and a stop of inclusion pending result. After this second analysis, none stop criteria was reached.
    15 Dec 2009

    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/25008258
    http://www.ncbi.nlm.nih.gov/pubmed/24557850
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