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    Clinical Trial Results:
    STEM CELL TRANSPLANTATION FOR ERADICATION OF MINIMAL PANCREATIC CANCER PERSISTING AFTER SURGICAL EXCISION

    Summary
    EudraCT number
    		 2012-003528-19
    Trial protocol
    		 DE  
    Global end of trial date
    13 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2020
    First version publication date
    11 Mar 2020
    Other versions
    Summary report(s)
    		 Statement STEM PACE 2012-003528-19

    Trial information

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    Trial identification
    Sponsor protocol code
    STEM PACE
    Additional study identifiers
    ISRCTN number
    		 ISRCTN47877138
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and Acting Business Director
    Sponsor organisation address
    Im Neuenheimer Feld 672, Heidelberg, Germany,
    Public contact
    Clinic of General Surgery, University Hospital Heidelberg, +49 62215639491,
    Scientific contact
    Clinic of General Surgery, University Hospital Heidelberg, +49 62215639491,
    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
    13 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The overall objective of this trial is to generate for the first time state-of-the-art scientific clinical evidence that allo-HSCT is feasible and can provide long-term disease control in patients with effectively resected pancreatic adenocarcinoma and may have the potential to change the natural course of this otherwise fatal malignancy.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2012
    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
    Germany: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Allo-HSCT
    Arm description
    		 allogeneic hematopoietic stem cell transplantation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allogeneic hematopoietic stem cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    N/A

    Number of subjects in period 1
    		Allo-HSCT
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 99999 99999
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Allo-HSCT
    Reporting group description
    		 allogeneic hematopoietic stem cell transplantation

    Primary: 2-year progression-free survival (PFS) from registration.

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    End point title
    		 2-year progression-free survival (PFS) from registration. [1]
    End point description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the Trial.
    End point type
    Primary
    End point timeframe
    N/A
    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: 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. No statistical analyses for this end point.
    End point values
    		 Allo-HSCT
    Number of subjects analysed
    99999 [2]
    Units: N/A
    99999
    Notes
    [2] - No subjects were enrolled in the trial hence results are not available.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Allo-HSCT
    Reporting group description
    		 N/A

    Serious adverse events
    		 Allo-HSCT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Allo-HSCT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    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: No subjects were enrolled in the trial hence results are not available .

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2013
    Clarifications and responses to subsequent demands of the Ethics Committee
    29 Jul 2014
    Change of Principal Inverstigator and update of inclusion and exclusion criteria

    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.
    No subjects were enrolled in the Trial hence results are not available.
    For support, Contact us.
    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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