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    Clinical Trial Results:
    A prospective, international, multi-centre, open-label,single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma patients

    Summary
    EudraCT number
    		 2021-001711-85
    Trial protocol
    		 DK   NL  
    Global end of trial date
    29 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2024
    First version publication date
    17 Mar 2024
    Other versions
    Summary report(s)
    		 A prospective, international, multi-centre, open-label, single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma p

    Trial information

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    Trial identification
    Sponsor protocol code
    PTF202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05222269
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pentixapharm AG
    Sponsor organisation address
    Bismarckstrasse 13, Würzburg, Germany, 97080
    Public contact
    Elisa Galvez, PIVOTAL, +34 664111890, elisa.galvez@pivotalcr.com
    Scientific contact
    Anja Zehnder, Pentixapharm AG, +49 931 99136075, anja.zehnder@pentixapharm.com
    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
    21 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the negative predictive value (NPV) of [68Ga]Ga-PentixaFor (PTF)-PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS).
    Protection of trial subjects
    -This study was conducted in accordance with the study protocol, the ethical principles that have their origins in the Declaration of Helsinki and also in agreement with the International Conference on Harmonisation (ICH) guidelines on Good Clinical Practice (GCP), as well as all other applicable country and regional legal and regulatory requirements. -Investigators were trained to conduct this study in accordance with the study protocol and ICH GCP guidelines. Written commitments were obtained from investigators to comply with GCP and to conduct the study in accordance with the protocol. The investigators were responsible for ensuring that this protocol, the site’s ICF, and other information that will be presented to potential subjects were reviewed and approved by the appropriate IRB/IEC prior to enrolment of any study subject. -Study-related data will be used by the sponsor in accordance with local data protection law. -All local and national radiation protection rules and regulations applicable to the use IMP and the conduct of clinical trials were adhered in this trial. -The Informed Consent forms were designed following the Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
    Background therapy
    		 -
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    25 Oct 2022
    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
    Denmark: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    0
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult patients of either sex with histologically confirmed primary or secondary CNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy will be recruited. Their disease must be previously untreated and located exclusively in the CNS, Approximately 50 patients were planned in USA and EU

    Pre-assignment
    Screening details
    		 The screening phase will last for a maximum of 14 days. Patients withdrawn from the study up to Visit 3 of the study will be replaced.

    Pre-assignment period milestones
    Number of subjects started
    		 2 [1]
    Number of subjects completed
    		 1

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Inclusion criteria not met: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We have equaled the pre-assignment period with the screening period (two patients), and only one of those patients met the I/E criteria. Hence only one patient was recruited.
    Period 1
    Period 1 title
    Whole approved population (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Whole approved population
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]Ga-PentixaFor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infusion , Injection
    Dosage and administration details
    In a volume of approximately 10 ml. A single dose is drawn from this solution according to the desired activity (150±50 MBq) and is to be administered to the patient as a bolus injection at a rate of approximately 10 ml per minute, with a resulting bolus duration of approximately 1 minute.

    Number of subjects in period 1
    		Whole approved population
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole approved population
    Reporting group description
    		 -

    Reporting group values
    		 Whole approved population Total
    Number of subjects
    		 1 1
    Age categorical
    Subjects from 18 years or above
    Units: Subjects
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 69 (69 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 1 1
        Other
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Whole approved population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary analysis of efficacy and safety will be based on the full analysis set (FAS) which will be defined as all enrolled patients who received at least one PTF administration.

    Subject analysis sets values
    		 Whole approved population
    Number of subjects
    1
    Age categorical
    Subjects from 18 years or above
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    69 (69 to 69*)
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    1
        Other
    0

    End points

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    End points reporting groups
    Reporting group title
    Whole approved population
    Reporting group description
    		 -

    Subject analysis set title
    Whole approved population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary analysis of efficacy and safety will be based on the full analysis set (FAS) which will be defined as all enrolled patients who received at least one PTF administration.

    Primary: NPV of [68Ga]Ga-PentixaFor (PTF)-PET for PFS

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    End point title
    		 NPV of [68Ga]Ga-PentixaFor (PTF)-PET for PFS [1]
    End point description
    Negative predictive value (NPV) of PTF-PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS)
    End point type
    Primary
    End point timeframe
    4-8 weeks
    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: Only a percentage of patients who have not progressed was planned as the primary end point. It was planned with a 95% IC. This was mainly descriptive
    End point values
    		 Whole approved population
    Number of subjects analysed
    1
    Units: percentage
        number (not applicable)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From 25/Oct/2022 to 25-Jan-23
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Patients fulfilling I/E criteria who signed ICF
    Reporting group description
    		 -

    Serious adverse events
    		 Patients fulfilling I/E criteria who signed ICF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Patients fulfilling I/E criteria who signed ICF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Infections and infestations
    Fungal infection
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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