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    Clinical Trial Results:
    A randomized, parallel group, multi-centre phase-2 study of GX-G3 compared with pegfilgrastim as an adjunct to chemotherapy in patients with Non-Hodgkin’s Lymphoma

    Summary
    EudraCT number
    		 2015-002693-20
    Trial protocol
    		 BG  
    Global end of trial date
    29 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2020
    First version publication date
    22 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GX‐G3_NHL_2/CGX14001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ilkogen Ilac San. ve Tic. A.S.
    Sponsor organisation address
    Sanayi Mahallesi Teknopark Bulvari No: 1/3 A/411 Pendik, İstanbul, Turkey, 34906
    Public contact
    Burcu Bulut, Ilkogen Ilac San. ve Tic. A.S., +90 2165648000, byilmaz@ilko.com.tr
    Scientific contact
    Burcu Bulut, Ilkogen Ilac San. ve Tic. A.S., +90 2165648000, byilmaz@ilko.com.tr
    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
    27 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the present trial is to assess the efficacy, safety, and tolerability of three doses of GX-G3 with the aim of selecting the optimal dose by comparing each of the doses with the reference product (Neulasta®). The major aim for including one group with delayed administration (250 μg/kg of GX-G3 on day 3 after R-CHOP dosing) is to evaluate the optimal point in time for dosing of the test product.
    Protection of trial subjects
    Continuous medical surveillance during the whole trial by means of: laboratory examinations, vital signs, check of exclusion/withdrawal criteria, adverse event questioning.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2017
    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
    Turkey: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Ukraine: 5
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Bulgaria: 26
    Country: Number of subjects enrolled
    Germany: 4
    Worldwide total number of subjects
    65
    EEA total number of subjects
    36
    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)
    38
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The results from screening and data collected during the study were recorded in the patient’s case report

    Period 1
    Period 1 title
    not provided (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 150 μg/kg body weight 24 hrs after R-CHOP administration (treatment A)
    Arm type
    		 Experimental

    Investigational medicinal product name
    GX-G3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 μg/kg body weight 24 hrs after R-CHOP administration (treatment A)

    Arm title
    		 Cohort 2
    Arm description
    		 250 μg/kg body weight 24 hrs after R-CHOP administration (treatment B)
    Arm type
    		 Experimental

    Investigational medicinal product name
    GX-G3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 μg/kg body weight 24 hrs after R-CHOP administration (treatment B)

    Arm title
    		 Cohort 3
    Arm description
    		 350 μg/kg body weight 24 hrs after R-CHOP administration (treatment C)
    Arm type
    		 Experimental

    Investigational medicinal product name
    GX-G3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    350 μg/kg body weight 24 hrs after R-CHOP administration (treatment C)

    Arm title
    		 Cohort 4
    Arm description
    		 Reference product (Neulasta®) (Treatment D)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Reference product (Neulasta®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Reference product (Neulasta®) (Treatment D)

    Arm title
    		 Cohort 5
    Arm description
    		 250 μg/kg body weight 72 hrs after R-CHOP administration (treatment E)
    Arm type
    		 Experimental

    Investigational medicinal product name
    GX-G3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 μg/kg body weight 72 hrs after R-CHOP administration (treatment E)

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
    Started
    14
    12
    13
    12
    14
    Completed
    14
    12
    13
    12
    14

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 150 μg/kg body weight 24 hrs after R-CHOP administration (treatment A)

    Reporting group title
    Cohort 2
    Reporting group description
    		 250 μg/kg body weight 24 hrs after R-CHOP administration (treatment B)

    Reporting group title
    Cohort 3
    Reporting group description
    		 350 μg/kg body weight 24 hrs after R-CHOP administration (treatment C)

    Reporting group title
    Cohort 4
    Reporting group description
    		 Reference product (Neulasta®) (Treatment D)

    Reporting group title
    Cohort 5
    Reporting group description
    		 250 μg/kg body weight 72 hrs after R-CHOP administration (treatment E)

    Subject analysis set title
    Primary Endpoint
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary objective of this study was to assess the efficacy, safety, and tolerability of three doses of GX-G3 with the aim of selecting the optimal dose by comparing each of the doses with the reference product (Neulasta®). Furthermore, the optimal point in time for dosing of the test product by delayed administration of 250 μg/kg body weight (BW) of GX-G3 72 hours after R-CHOP administration was evaluated.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    End point type
    Primary
    End point timeframe
    Time to recover from severe neutropenia (defined as ANC <0.5x10^9/l) to a target ≥0.5x10^9/l after each administration of R-CHOP chemotherapy in cycles 1 and 2
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
    Number of subjects analysed
    14
    12
    13
    12
    14
    Units: number
        arithmetic mean (standard deviation)
    3.833 ± 1.697
    2.500 ± 1.000
    3.375 ± 2.504
    3.571 ± 2.936
    2.636 ± 1.859
    Statistical analysis title
    		 Primary endpoint Full Analysis Set
    Statistical analysis description
    All randomized patients who received at least one dose of the study medication and who have at least one post-baseline assessment of the primary endpoint.
    Comparison groups
    Cohort 4 v Cohort 1 v Cohort 2 v Cohort 3 v Cohort 5
    Number of subjects included in analysis
    65
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.5
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The time of administration of the first cycle of treatment (study day 1) is designated as start of safety data collection. The data collection period ends with the final examination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Cohort 2
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Skin and subcutaneous tissue disorders
    itching
    alternative assessment type: Non-systematic
         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? Yes
    Date
    Amendment
    13 Apr 2016
    Changes in study protocol
    28 Sep 2016
    Change of sponsor address and project management
    16 Feb 2018
    Inclusion of 2 other countries

    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
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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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