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    Clinical Trial Results:
    Multicenter phase II single arm open-label study on the feasibility, safety and efficacy of combination of CHOP-21 supplemented with Obinutuzumab and Ibrutinib in untreated young high risk Diffuse Large B-cell Lymphoma (DLBCL) patients.

    Summary
    EudraCT number
    		 2015-005273-20
    Trial protocol
    		 IT  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2022
    First version publication date
    11 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FIL-GALILEO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02670317
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fondazione Italiana Linfomi (FIL) ONLUS
    Sponsor organisation address
    Piazza Turati 5, Alessandria, Italy,
    Public contact
    Segreteria, Fondazione Italiana Linfomi Onlus, +39 0131/033151, segreteriadirezione@filinf.it
    Scientific contact
    Segreteria, Fondazione Italiana Linfomi Onlus, +39 0131/033151, segreteriadirezione@filinf.it
    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
    03 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS; To evaluate the safety of G-CHOP-21 in combination with Ibrutinib (extra-hematologic toxicity = grade 3 or treatment interruption for safety reasons or any toxic death during the 6 cycles of treatment).
    Protection of trial subjects
    A subject must be discontinued from study treatment in case of: - completed treatment as per protocol - Patient withdraw consent to participate - the investigator believes that for safety reasons it is in the best interest of the subject to discontinue the treatment - disease progression at any time - occurrence of an unacceptable adverse event (> grade 3 toxicity for > 2 weeks) If the treatment is discontinued for more than 3 weeks patient is withdrawn from study protocol treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2016
    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
    Italy: 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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 One patient recruited in Italy from September 2, 2016, with date of last completed February 17, 2017 (date of early closure of study).

    Pre-assignment
    Screening details
    		 Patients (18-60 years) with poor-prognosis (age-adjusted International Prognostic Index, aaIPI, 2 or 3) newly diagnosed DLBCL. All patients must satisfy all the inclusion criteria and none of exclusion criteria.

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

    Arms
    Arm title
    		 Single arm
    Arm description
    		 One single arm. Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
    Arm type
    		 Single arm study

    Investigational medicinal product name
    Ibrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    560 mg (4 x 140mg capsules) per os (PO) QD, day 1-126 once daily

    Investigational medicinal product name
    Obinutuzumab (G)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg, intra venous (IV) days 1, 8, 15, 21, 42, 63, 84, 105, 126,147. It is allowed to split the first Obinutuzumab infusion over 2 days (day 1 and 2) if the patient is at increased risk for infusion related reaction (IRR) (high tumor burden, high peripheral lymphocyte count or other medical conditions).

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide: 750 mg/m2, IV on day 1 CHOP (Cyclophosphamide, Adriamycin, Vincristine, Prednisone) will be administered according to the standard preparation and infusion procedures at each investigational site and at least 30 minutes after the Obinutuzumab infusion. CHOP-21: days 1, 21, 42, 63, 84, 105

    Investigational medicinal product name
    Adriamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Adriamycin: 50 mg/m2, IV on day 1 CHOP (Cyclophosphamide, Adriamycin, Vincristine, Prednisone) will be administered according to the standard preparation and infusion procedures at each investigational site and at least 30 minutes after the Obinutuzumab infusion. CHOP-21: days 1, 21, 42, 63, 84, 105

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vincristine: 1.4 mg/m2, IV on day 1, (max 2 mg) CHOP (Cyclophosphamide, Adriamycin, Vincristine, Prednisone) will be administered according to the standard preparation and infusion procedures at each investigational site and at least 30 minutes after the Obinutuzumab infusion. CHOP-21: days 1, 21, 42, 63, 84, 105

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone: 100 mg/day, PO on day 1-5 CHOP (Cyclophosphamide, Adriamycin, Vincristine, Prednisone) will be administered according to the standard preparation and infusion procedures at each investigational site and at least 30 minutes after the Obinutuzumab infusion. CHOP-21: days 1, 21, 42, 63, 84, 105

    Number of subjects in period 1
    		Single arm
    Started
    1
    Completed
    1

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 One single arm. Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS) [1]
    End point description
    PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.
    End point type
    Primary
    End point timeframe
    2 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: Only one patient was enrolled, the study is officially closed by 17/2/2017. Analyzes not carried out.
    End point values
    		 Single arm
    Number of subjects analysed
    0 [2]
    Units: Probability
        number (confidence interval 95%)
    ( to )
    Notes
    [2] - Only one patient was enrolled,the study is officially closed by 17/2/2017. Analyzes not carried out
    No statistical analyses for this end point

    Primary: Clinical relevant toxicity

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    End point title
    		 Clinical relevant toxicity [3]
    End point description
    To evaluate the safety of G-CHOP-21 in combination with Ibrutinib in terms of proportion of patients experiencing grade 3 or greater extrahematologic toxicity or treatment interruption for safety reasons or any toxic death during the 6 cycles of treatment. Clinical relevant toxicity will be defined as the proportion of patients experiencing a grade 3 or greater extra-hematologic toxicity or treatment interruption for safety reasons due to patient or clinical decisions or any toxic death during the 6 cycles of treatment.
    End point type
    Primary
    End point timeframe
    5 months of treatment
    Notes
    [3] - 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 one patient was enrolled, the study is officially closed by 17/2/2017. Analyzes not carried out.
    End point values
    		 Single arm
    Number of subjects analysed
    0 [4]
    Units: Subject
    Notes
    [4] - Only one patient was enrolled,the study is officially closed by 17/2/2017. Analyzes not carried out.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 -

    Serious adverse events
    		 Single arm
    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
    		 Single arm
    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
    2
    General disorders and administration site conditions
    Fever
         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? Yes
    Date
    Interruption
    Restart date
    17 Feb 2017
    The reasons for the early closure are as follows. The association Obinutuzamab - CHOP, investigated by the study, cannot have clinical development in large B lymphomas cells in the forefront. The results of the study were reported at the ASH 2016 meeting Randomized Goya (Rituximab -CHOP versus Obinutuzumab-CHOP), conducted on 1418 patients. The study results showed no significant survival advantage disease-free (PFS) and overall survival (OS) by the replacement of Rituximab with Obinutuzumab (Vitolo et al. - "Obinutuzumab or Rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymhoma: final results from an open-label, randomized phase 3 study (GOYA) "- 58th ASH Meeting San Diego 2016 - Abstract 470). Therefore, there not will be expected neither experimental developments nor further approvals by the competent authorities for the use of the association Obinutuzumab-CHOP in large-cell B lymphomas. For this reason, the addition of the drug Ibrutinib to the Obinutuzumab-CHOP association no longer has any logic and interest in the future clinical practice. The study is officially closed starting from 17/2/2017. Only 1 patient was enrolled in the study (coordinating center), and the data collection and follow-up analysis will be guaranteed.
    -

    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
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