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    Clinical Trial Results:
    Allogenic stem cell transplantation with CD3/CD19 depleted stem cells from haploidentical related and non-related donators in pediatric patients with and without malignant systemic diseases.

    Summary
    EudraCT number
    		 2006-000393-76
    Trial protocol
    		 DE  
    Global end of trial date
    18 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2021
    First version publication date
    16 Dec 2021
    Other versions
    Summary report(s)
    		 ZKI-SCT-HAPLO-0106_Report Synopsis of Study

    Trial information

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    Trial identification
    Sponsor protocol code
    ZKI-SCT-HAPLO-0106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johann Wolfgang Goethe Universität
    Sponsor organisation address
    Senckenberganlage 31, Frankfurt am Main, Germany,
    Public contact
    Division for stem cell transplantat, University hospital frankfurt, Department for children and adolescents, ++49 696301-7542, peter.bader@kgu.de
    Scientific contact
    Division for stem cell transplantat, University hospital frankfurt, Department for children and adolescents, ++49 696301-7542, peter.bader@kgu.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
    15 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluation of the engraftment rate after preparation of the stem cell transplant with CD3/CD19 depletion and administration of approximatelly 7x10E6/kg body weight CD34+ cells. Engraftment is defined as leucocytes >1000µl, neutrophiles >500µl and thrombocytes >20.000/µl on day 28 after transplantation.
    Protection of trial subjects
    All patients were investigated daily by physicians and nurses and if necessary appropriate treatment was initiated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 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
    Germany: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    7
    Children (2-11 years)
    27
    Adolescents (12-17 years)
    23
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with an indication for allogeneic transplantation were screened and patients fullfilling inclusion criteria and not being scope of exclusion criteria were included.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OKT-3
    Arm description
    		 All patients receiving the monoclonal antibody Orthoclone-3.
    Arm type
    		 Subgroup

    Investigational medicinal product name
    Orthoclone OKT3®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for suspension for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    The initial recommended dose is 2.5 mg per day in pediatric patients weighing less than or equal to 30 kg and 5 mg per day in pediatric patients weighing greater than 30 kg in a single (bolus) intravenous injection in less than one minute for 10 to 14 days.

    Arm title
    		 ATG Fresenius
    Arm description
    		 All patients receiving the polyclonal amtibody ATG Fresenius.
    Arm type
    		 Subgroup

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Campath
    Arm description
    		 All patients receiving the monoclonal antibody CAMPATH
    Arm type
    		 Subgroup

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		OKT-3 ATG Fresenius Campath
    Started
    51
    11
    5
    Completed
    51
    11
    5
    Period 2
    Period 2 title
    Intervention
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OKT-3
    Arm description
    		 -
    Arm type
    		 Subgroup

    Investigational medicinal product name
    Orthoclone OKT3®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for suspension for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    The initial recommended dose is 2.5 mg per day in pediatric patients weighing less than or equal to 30 kg and 5 mg per day in pediatric patients weighing greater than 30 kg in a single (bolus) intravenous injection in less than one minute for 10 to 14 days.

    Arm title
    		 ATG Fresenius
    Arm description
    		 All patients receiving the polyclonal antobody ATG Fresenius.
    Arm type
    		 Subgroup

    Investigational medicinal product name
    ATG-Fresenius S 20 mg/ml Konzentrat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Prävention einer akuten Transplantatabstoßung bei Empfängern allogener Organtransplantate Der empfohlene Dosisbereich beträgt 2 bis 5 mg/kg KG/Tag ATG-Fresenius S. Am häufigsten werden Dosierungen zwischen 3 und 4 mg/kg KG/Tag eingesetzt. Mit der Therapie ist am Transplantationstag prä-, intra- oder unmittelbar postoperativ zu beginnen. In Abhängigkeit vom Zustand des Patienten, der gewählten Tagesdosis und der gleichzeitig eingesetzten weiteren Immunsuppressiva liegt die empfohlene Dauer der Anwendung zwischen 5 und 14 Tagen. Behandlung einer akuten steroidresistenten Abstoßung nach allogener Organtransplantation Der empfohlene Dosisbereich beträgt 3 bis 5 mg/kg KG/Tag ATG-Fresenius S. Am häufigsten werden Dosierungen zwischen 3 und 4 mg/kg KG/Tag eingesetzt. Die Dauer der Anwendung richtet sich nach dem Zustand des transplantierten Organs und dem klinischen Ansprechen und liegt in der Regel zwischen 5 und 14 Tagen. Prävention der Graft-versus-Host-Erkrankung (GVHD) bei Stamm

    Arm title
    		 Campath
    Arm description
    		 -
    Arm type
    		 Subgroup

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		OKT-3 ATG Fresenius Campath
    Started
    51
    11
    5
    Completed
    30
    3
    1
    Not completed
    21
    8
    4
         Adverse event, serious fatal
    20
    7
    4
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OKT-3
    Reporting group description
    		 All patients receiving the monoclonal antibody Orthoclone-3.

    Reporting group title
    ATG Fresenius
    Reporting group description
    		 All patients receiving the polyclonal amtibody ATG Fresenius.

    Reporting group title
    Campath
    Reporting group description
    		 All patients receiving the monoclonal antibody CAMPATH

    Reporting group values
    		 OKT-3 ATG Fresenius Campath Total
    Number of subjects
    		 51 11 5 67
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.1 ( 6.6 ) 6.2 ( 4.0 ) 18.6 ( 4.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 7 3 40
        Male
    		 21 4 2 27
    Basic disease
    Units: Subjects
        ALL, AML or CML
    		 27 4 5 36
        Solid Tumor
    		 12 3 0 15
        Other
    		 12 4 0 16
    Disease status at transplantation
    Units: Subjects
        CR
    		 27 6 5 38
        no CR
    		 24 5 0 29
    Number of previous transplantations
    Units: Subjects
        No transplantation
    		 27 6 1 34
        One transplantation
    		 20 4 4 28
        Twor ore more transplantations
    		 2 1 0 3
        Not applicable
    		 2 0 0 2
    Gender of donor
    Units: Subjects
        male
    		 27 5 0 32
        female
    		 24 6 5 35
    Relationship to recipient
    Units: Subjects
        Not related
    		 9 2 0 11
        Monozygous Twin
    		 0 0 0 0
        Sybling
    		 11 0 0 11
        Parent
    		 31 9 5 45
    Age of donor
    Units: years
        arithmetic mean (standard deviation)
    		 35.0 ( 9.3 ) 39.4 ( 7.1 ) 36.6 ( 6.4 ) -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled Patients who received stem cell transplantation.

    Subject analysis set title
    OKT-3 Subgroup related donor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who received a transplant from a related donor

    Subject analysis set title
    OKT-3 Subgroup unrelated donor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who received a tranplant from an unrelated donor

    Subject analysis set title
    OKT-3 Subgroup ALL/AML/CML
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who had ALL/AML or CML as underlying disease

    Subject analysis set title
    OKT-3 Subgroup Solid Tumor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who had a solid tumor as underlying disease

    Subject analysis set title
    OKT-3 Subgroup other underlying disease
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group with other than ALL/AML/CML or solid tumor as underlying disease.

    Subject analysis sets values
    		 ITT OKT-3 Subgroup related donor OKT-3 Subgroup unrelated donor OKT-3 Subgroup ALL/AML/CML OKT-3 Subgroup Solid Tumor OKT-3 Subgroup other underlying disease
    Number of subjects
    67
    42
    9
    27
    12
    12
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10,9 ( 6,4 )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    40
        Male
    27
    Basic disease
    Units: Subjects
        ALL, AML or CML
    36
        Solid Tumor
    15
        Other
    16
    Disease status at transplantation
    Units: Subjects
        CR
    38
        no CR
    29
    Number of previous transplantations
    Units: Subjects
        No transplantation
    34
        One transplantation
    28
        Twor ore more transplantations
    3
        Not applicable
    2
    Gender of donor
    Units: Subjects
        male
    32
        female
    35
    Relationship to recipient
    Units: Subjects
        Not related
    11
        Monozygous Twin
    0
        Sybling
    11
        Parent
    45
    Age of donor
    Units: years
        arithmetic mean (standard deviation)
    35.8 ( 8.9 )
    ( )
    ( )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    OKT-3
    Reporting group description
    		 All patients receiving the monoclonal antibody Orthoclone-3.

    Reporting group title
    ATG Fresenius
    Reporting group description
    		 All patients receiving the polyclonal amtibody ATG Fresenius.

    Reporting group title
    Campath
    Reporting group description
    		 All patients receiving the monoclonal antibody CAMPATH
    Reporting group title
    OKT-3
    Reporting group description
    		 -

    Reporting group title
    ATG Fresenius
    Reporting group description
    		 All patients receiving the polyclonal antobody ATG Fresenius.

    Reporting group title
    Campath
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled Patients who received stem cell transplantation.

    Subject analysis set title
    OKT-3 Subgroup related donor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who received a transplant from a related donor

    Subject analysis set title
    OKT-3 Subgroup unrelated donor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who received a tranplant from an unrelated donor

    Subject analysis set title
    OKT-3 Subgroup ALL/AML/CML
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who had ALL/AML or CML as underlying disease

    Subject analysis set title
    OKT-3 Subgroup Solid Tumor
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group who had a solid tumor as underlying disease

    Subject analysis set title
    OKT-3 Subgroup other underlying disease
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients of the OKT-3 group with other than ALL/AML/CML or solid tumor as underlying disease.

    Primary: Engraftmentrate

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    End point title
    		 Engraftmentrate [1]
    End point description
    Engraftmentrate 28 days after transplantation. Engraftment is defined as - lymphocyte status > 1000/µl, - neutrophil status > 500/µl and -thrombocyte status > 20000ml
    End point type
    Primary
    End point timeframe
    28 days after transplantation
    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: This was a single arm open study, for which no confirmatory or exploratory tests were planned. It was intended to increase the engraftment rate with this new therapy compared to the standard therapy (engraftment=85%) at time of study planning. The different subgroups presented in the analyses here were analysed separately due to the possible impacts of the different conditioning antibodies which had to be used after OKT-3 was taken off the market.
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    51
    Units: Number of patients
    41
    6
    4
    51
    No statistical analyses for this end point

    Secondary: Leukocyte status

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    End point title
    		 Leukocyte status
    End point description
    Leukocyte count is part of the primary endpoint "engraftment".
    End point type
    Secondary
    End point timeframe
    28 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    67
    Units: Number of patients
        Leukocyte count > 1000/µL
    51
    10
    5
    66
        Leukocyte count < 1000/µL
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Neutrophil status

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    End point title
    		 Neutrophil status
    End point description
    The Neutrophil status is part of the primary endpoint "engraftment".
    End point type
    Secondary
    End point timeframe
    28 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    67
    Units: Number of patients
        Neutrophil count >500/µL
    51
    10
    5
    66
        Neutrophil count <500/µL
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Thrombocyte status

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    End point title
    		 Thrombocyte status
    End point description
    Thrombocyte status is part of the primary endpoint "engraftment".
    End point type
    Secondary
    End point timeframe
    28 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    67
    Units: Number of patients
        Thrmobocyte count > 20000/µL
    48
    8
    4
    60
        Thrombocyte count < 20000/µL
    3
    3
    1
    7
    No statistical analyses for this end point

    Secondary: Transplant failure

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    End point title
    		 Transplant failure
    End point description
    End point type
    Secondary
    End point timeframe
    28 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    67
    Units: Number of patients
        Yes
    5
    3
    0
    8
        No
    46
    8
    5
    59
    No statistical analyses for this end point

    Secondary: Type of transplant failure

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    End point title
    		 Type of transplant failure
    End point description
    End point type
    Secondary
    End point timeframe
    28 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath ITT
    Number of subjects analysed
    51
    11
    5
    67
    Units: Number of patients
        Non-engraftment
    0
    1
    0
    1
        Rejection
    5
    2
    0
    7
    No statistical analyses for this end point

    Secondary: Time to primary engraftment

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    End point title
    		 Time to primary engraftment
    End point description
    Engraftment as defined for primary endpoint: Lymphocyte count > 1000/µL Neutrophil count > 500/µL and Thrombocyte count > 20000µL In case median and/ or confindece intervals could not be computed, “999" was used.
    End point type
    Secondary
    End point timeframe
    Median time to primary engraftment within first 28 days after transplantation.
    End point values
    		 OKT-3 ATG Fresenius Campath OKT-3 Subgroup related donor OKT-3 Subgroup unrelated donor
    Number of subjects analysed
    51
    11
    5
    42
    9
    Units: Days
        median (confidence interval 95%)
    17.0 (16.0 to 19.0)
    22.0 (15.0 to 999)
    13.0 (12.0 to 999)
    17 (16 to 19)
    17 (12 to 24)
    No statistical analyses for this end point

    Secondary: Toxicities

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    End point title
    		 Toxicities
    End point description
    Number of patients with at least 1 toxicity with 365 days after transplantation.
    End point type
    Secondary
    End point timeframe
    Within 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of patients
        At least 1 toxicity
    51
    11
    5
        No toxicity
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of toxicities per patient

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    End point title
    		 Number of toxicities per patient
    End point description
    Number of toxicities per patient within 365 days after transplantation.
    End point type
    Secondary
    End point timeframe
    Within 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number
        median (full range (min-max))
    21.0 (11 to 44)
    19.0 (10 to 44)
    19.0 (10 to 38)
    No statistical analyses for this end point

    Secondary: Acute graft-versus-host reaction

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    End point title
    		 Acute graft-versus-host reaction
    End point description
    End point type
    Secondary
    End point timeframe
    Within 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of patients
        Yes
    34
    4
    2
        No
    17
    7
    3
    No statistical analyses for this end point

    Secondary: Chronic graft-versus-host reaction

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    End point title
    		 Chronic graft-versus-host reaction
    End point description
    End point type
    Secondary
    End point timeframe
    Within 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of patients
        Yes
    3
    0
    0
        No
    48
    11
    5
    No statistical analyses for this end point

    Secondary: Reasons for tranplantation-related mortality

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    End point title
    		 Reasons for tranplantation-related mortality
    End point description
    Multiple answers possible
    End point type
    Secondary
    End point timeframe
    Wihin 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of Patients
        Graft-versus-host reaction
    2
    1
    0
        Pulmonal toxicity
    0
    1
    0
        Infection
    4
    4
    2
        Other
    3
    2
    2
    No statistical analyses for this end point

    Secondary: Transplantion-related mortality

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    End point title
    		 Transplantion-related mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Within 365 days after transplantation
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of patients
        Yes
    6
    6
    3
        No
    45
    5
    2
    No statistical analyses for this end point

    Secondary: Duration of remission

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    End point title
    		 Duration of remission
    End point description
    In case median and/ or confindece intervals could not be computed, "999" was used.
    End point type
    Secondary
    End point timeframe
    Time from remssion to recurrence or death, whatever comes first
    End point values
    		 OKT-3 ATG Fresenius Campath OKT-3 Subgroup ALL/AML/CML OKT-3 Subgroup Solid Tumor OKT-3 Subgroup other underlying disease
    Number of subjects analysed
    51
    11
    5
    27
    12
    12
    Units: days
        median (confidence interval 95%)
    999 (999 to 999)
    169 (50 to 199)
    999 (999 to 999)
    999 (188 to 999)
    291 (61 to 999)
    999 (999 to 999)
    No statistical analyses for this end point

    Secondary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Within study
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: Number of patients
        Yes
    20
    7
    4
        No
    31
    4
    1
    No statistical analyses for this end point

    Secondary: Survival time

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    End point title
    		 Survival time
    End point description
    Time to death, censored at drop-out or end of study. In case median and/ or confidence intervals coul not be computed, the code "999" is used.
    End point type
    Secondary
    End point timeframe
    Within study
    End point values
    		 OKT-3 ATG Fresenius Campath OKT-3 Subgroup related donor OKT-3 Subgroup unrelated donor OKT-3 Subgroup ALL/AML/CML OKT-3 Subgroup Solid Tumor OKT-3 Subgroup other underlying disease
    Number of subjects analysed
    51
    11
    5
    42
    9
    27
    12
    12
    Units: days
        median (confidence interval 95%)
    999 (231 to 999)
    999 (53 to 999)
    999 (46 to 999)
    999 (221 to 999)
    999 (257 to 999)
    999 (155 to 999)
    999 (186 to 999)
    999 (257 to 999)
    No statistical analyses for this end point

    Secondary: Event-free survival

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    End point title
    		 Event-free survival
    End point description
    Censored at end of study or drop-out In case median and/ or confindece intervals could not be computed, "999" was used.
    End point type
    Secondary
    End point timeframe
    Time to transplant failure, relapse or death, whatever comes first
    End point values
    		 OKT-3 ATG Fresenius Campath OKT-3 Subgroup ALL/AML/CML OKT-3 Subgroup Solid Tumor OKT-3 Subgroup other underlying disease
    Number of subjects analysed
    51
    11
    5
    27
    12
    12
    Units: days
        median (confidence interval 95%)
    999 (155 to 999)
    53 (24 to 153)
    124 (46 to 999)
    999 (96 to 999)
    218.5 (33 to 999)
    999 (97 to 999)
    No statistical analyses for this end point

    Secondary: Disease-free survival

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    End point title
    		 Disease-free survival
    End point description
    Censored at end of study or lost-to follow-up In case median and/ or confindece intervals could not be computed, “999" was used.
    End point type
    Secondary
    End point timeframe
    Time to relapse or death, whatever comes first
    End point values
    		 OKT-3 ATG Fresenius Campath
    Number of subjects analysed
    51
    11
    5
    Units: days
        median (confidence interval 95%)
    999 (188 to 999)
    153 (50 to 218)
    124 (46 to 999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From transplantation to end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    OKT-3
    Reporting group description
    		 Patients who received the monoclonal antibody Orthoclone-3 (OKT-3).

    Reporting group title
    ATG Fresenius
    Reporting group description
    		 Patients receiving the polyclonal antibody ATG Fresenius

    Reporting group title
    CAMPATH
    Reporting group description
    		 Patients who received the monoclonal antibody CAMPATH.

    Reporting group title
    Total
    Reporting group description
    		 All patients treated in the study

    Serious adverse events
    		 OKT-3 ATG Fresenius CAMPATH Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 51 (58.82%)
    7 / 11 (63.64%)
    4 / 5 (80.00%)
    41 / 67 (61.19%)
         number of deaths (all causes)
    20
    7
    4
    31
         number of deaths resulting from adverse events
    1
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    4 / 67 (5.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatoblastoma recurrent
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Recurrent cancer
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venoocclusive disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 11 (27.27%)
    1 / 5 (20.00%)
    8 / 67 (11.94%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    1 / 5 (20.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in skin
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Adenovirus test positive
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyomavirus test positive
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspergillus test positive
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood urine
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Transplant failure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 OKT-3 ATG Fresenius CAMPATH Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 51 (41.18%)
    3 / 11 (27.27%)
    2 / 5 (40.00%)
    26 / 67 (38.81%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    3 / 67 (4.48%)
         occurrences all number
    2
    0
    1
    3
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 11 (18.18%)
    1 / 5 (20.00%)
    8 / 67 (11.94%)
         occurrences all number
    6
    3
    2
    11
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    5 / 51 (9.80%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    6 / 67 (8.96%)
         occurrences all number
    7
    2
    0
    9
    Adenovirus infection
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Epstein-Barr virus infection
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Herpes zoster
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    2 / 67 (2.99%)
         occurrences all number
    2
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2006
    Amendment 01, study start
    08 Mar 2007
    Amendment 02, change of sponsor
    26 May 2010
    Amendment 04, prolongation of study, increase of number of study participants
    14 May 2012
    Amendment 05, temporary stop of study
    17 Jun 2014
    Amendment 06, Re-start of study

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 May 2012
    temporary stop of study due to withdraw of one conditioning drug from the market
    17 Jun 2014

    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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