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    Clinical Trial Results:
    Randomized Phase III study evaluating the non-inferiority of a treatment adapted to the early response evaluated with 18F-FDG PET compared to a standard treatment, for patients aged from 18 to 80 years with low risk (aa IPI = 0) diffuse large B-cells non hodgkin's lymphoma CD 20+

    Summary
    EudraCT number
    		 2009-017279-77
    Trial protocol
    		 FR   BE  
    Global end of trial date
    23 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Nov 2023
    First version publication date
    24 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LNH2009-1B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01285765
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Nancy – Direction de la Recherche et de l’Innovation
    Sponsor organisation address
    Hôpital Saint Julien – Rue Foller – Case Officielle 60034, Nancy, France,
    Public contact
    Fabienne MORAND - Project Manager, LYSARC, +33 (0)472 66 93 33, lnh09-1b@lysarc.org
    Scientific contact
    Serge Bologna, LYSARC, +33 (0)472 66 93 33, s.bologna@oncog.fr
    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
    23 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate by PFS at 3 years the non-inferiority of a chemotherapy treatment with 4 or 6 cycles of R-CHOP 21, determined according to early response assessed by PET at the end of 2 cycles versus standard chemotherapy of 6 cycles of R-CHOP 21 in patients with DLBCL lymphoma CD20+ with no factors of the IPI age adjusted.
    Protection of trial subjects
    No rescue treatment during this study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2010
    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
    Belgium: 74
    Country: Number of subjects enrolled
    France: 576
    Worldwide total number of subjects
    650
    EEA total number of subjects
    650
    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)
    473
    From 65 to 84 years
    177
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 576 patients were recruited in France between december 2010 and may 2017 74 patients were recruited in Belgium between august 2011 and april 2017

    Pre-assignment
    Screening details
    		 650 patients were randomized. Among them, 646 patients received at least dose of treatment regimen.

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard
    Arm description
    		 6 cycles of R-CHOP 21
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Experimental
    Arm description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R-CHOP 21
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Prednisone 60 mg/m2 Rituximab 375 mg/m2 Doxorubicin 50 mg/m2 Cyclophosphamide 750 mg/m2 Vincristine 1.4 mg/m2 G-CSF (SC) 5 ug/kg/day (optional)

    Number of subjects in period 1
    		Standard Experimental
    Started
    331
    319
    Completed
    289
    275
    Not completed
    42
    44
         Consent withdrawn by subject
    2
    -
         death
    2
    1
         progression
    4
    1
         Other
    4
    8
         concurrent illness
    5
    2
         toxicity of study treatment
    3
    -
         Lack of efficacy
    17
    23
         Protocol deviation
    5
    9
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard
    Arm description
    		 6 cycles of R-CHOP 21
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Experimental
    Arm description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    R-CHOP 21
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Prednisone 60 mg/m2 Rituximab 375 mg/m2 Doxorubicin 50 mg/m2 Cyclophosphamide 750 mg/m2 Vincristine 1.4 mg/m2 G-CSF (SC) 5 ug/kg/day (optional)

    Number of subjects in period 2
    		Standard Experimental
    Started
    289
    275
    Completed
    289
    275

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard
    Reporting group description
    		 6 cycles of R-CHOP 21

    Reporting group title
    Experimental
    Reporting group description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.

    Reporting group values
    		 Standard Experimental Total
    Number of subjects
    		 331 319 650
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 244 229 473
        From 65-84 years
    		 87 90 177
    Gender categorical
    Units: Subjects
        Female
    		 132 137 269
        Male
    		 199 182 381
    Subject analysis sets

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients randomized

    Subject analysis sets values
    		 Intention to treat
    Number of subjects
    650
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    473
        From 65-84 years
    177
    Age continuous
    Units: years
        median
    ( )
    Gender categorical
    Units: Subjects
        Female
    269
        Male
    381

    End points

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    End points reporting groups
    Reporting group title
    Standard
    Reporting group description
    		 6 cycles of R-CHOP 21

    Reporting group title
    Experimental
    Reporting group description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.
    Reporting group title
    Standard
    Reporting group description
    		 6 cycles of R-CHOP 21

    Reporting group title
    Experimental
    Reporting group description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients randomized

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Primary
    End point timeframe
    From the date of randomization to the date of first documented disease progression, relapse or death from any cause, whichever occurs first
    End point values
    		 Standard Experimental
    Number of subjects analysed
    331
    319
    Units: percent
    number (confidence interval 90%)
        3 years
    89.2 (85.3 to 92.2)
    92.0 (88.3 to 94.5)
    Attachments
    		 PFS
    Statistical analysis title
    		 PFS non-inferiority
    Statistical analysis description
    Non-inferiority on PFS
    Comparison groups
    Experimental v Standard
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.724
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.504
         upper limit
    		 1.04
    Notes
    [1] - The trial was designed based on a non-inferiority margin of 10% (corresponding to a 3-year PFS of 80% in the control arm vs >70% in the experimental arm, HR=1.6). If the upper limit of the confidence interval is strictly lower than the non-inferiority margin (HR = 1.6), the non-inferiority of experimental arm vs standard arm will be demonstrated.
    Statistical analysis title
    		 PFS superiority
    Comparison groups
    Standard v Experimental
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0702 [2]
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Superiority of experimental arm

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of randomization to the date of death from any cause
    End point values
    		 Standard Experimental
    Number of subjects analysed
    331
    319
    Units: percent
    number (confidence interval 95%)
        3 years
    95.7 (92.8 to 97.4)
    97.7 (95.3 to 98.9)
    Attachments
    		 OS
    Statistical analysis title
    		 OS
    Comparison groups
    Standard v Experimental
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.127 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.612
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.323
         upper limit
    		 1.157
    Notes
    [3] - Bilateral p-value

    Secondary: Event-free survival

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    End point title
    		 Event-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.
    End point values
    		 Standard Experimental
    Number of subjects analysed
    331
    319
    Units: percent
    number (confidence interval 95%)
        3 years
    82.6 (78.0 to 86.3)
    84.8 (80.3 to 88.3)
    Attachments
    		 EFS
    Statistical analysis title
    		 EFS
    Comparison groups
    Experimental v Standard
    Number of subjects included in analysis
    650
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3412 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.847
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.598
         upper limit
    		 1.198
    Notes
    [4] - Bilateral p-value

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of response will be measured from the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause.
    End point values
    		 Standard Experimental
    Number of subjects analysed
    318 [5]
    303 [6]
    Units: percent
    number (confidence interval 95%)
        3 years
    91.1 (87.4 to 93.8)
    93.6 (90.1 to 95.9)
    Attachments
    		 DoR
    Notes
    [5] - Patients who reached CR or PR during study
    [6] - Patients who reached CR or PR during study
    Statistical analysis title
    		 DoR
    Comparison groups
    Experimental v Standard
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.151 [7]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.709
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.443
         upper limit
    		 1.136
    Notes
    [7] - Bilateral p-value

    Secondary: Complete response rate

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    End point title
    		 Complete response rate
    End point description
    Response was assessed according to Cheson 2007 criteria.
    End point type
    Secondary
    End point timeframe
    End of treatment = 4 or 6 cycles if patient received all planned cycles otherwise at withdrawal
    End point values
    		 Standard Experimental
    Number of subjects analysed
    331
    319
    Units: Percentage
        number (confidence interval 95%)
    86.0 (81.79 to 89.58)
    87.5 (83.32 to 90.89)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after the last study drug administration
    Adverse event reporting additional description
    All events that meet one or more criteria of seriousness occurred after the informed consent up to 30 days after the last study drug administration, regardless the relationship to the study treatment, will be reported as SAE. A SAE that occurs after this time, including during the follow-up period, if considered related to the study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Standard
    Reporting group description
    		 6 cycles of R-CHOP 21

    Reporting group title
    Experimental
    Reporting group description
    		 4 or 6 cycles of R-CHOP 21 The number of cycle to be administered is depending on the results assessed by PET after the cycle 2 and 4 : - If the PET is negative after cycle 2 and cycle 4, 4 cycles will be administered in total. - If the PET is positive after cycle 2 and negative after cycle 4, 6 cycles will be administered in total. - If the PET is positive after cycle 2 and 4 (or negative after cycle 2 and positive after cycle 4), the patient will be withdrawn from the study with a pathological confirmation by biopsy of the lesion if possible. A Salvage treatment will be administered.

    Serious adverse events
    		 Standard Experimental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 330 (14.24%)
    30 / 316 (9.49%)
         number of deaths (all causes)
    26
    15
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm benign, malignant and unspecified
         subjects affected / exposed
    8 / 330 (2.42%)
    7 / 316 (2.22%)
         occurrences causally related to treatment / all
    3 / 9
    4 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    5 / 330 (1.52%)
    3 / 316 (0.95%)
         occurrences causally related to treatment / all
    8 / 8
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    5 / 330 (1.52%)
    4 / 316 (1.27%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    5 / 330 (1.52%)
    1 / 316 (0.32%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    3 / 330 (0.91%)
    1 / 316 (0.32%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    4 / 330 (1.21%)
    1 / 316 (0.32%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye disorders
         subjects affected / exposed
    0 / 330 (0.00%)
    1 / 316 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    6 / 330 (1.82%)
    5 / 316 (1.58%)
         occurrences causally related to treatment / all
    6 / 6
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    1 / 330 (0.30%)
    1 / 316 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    3 / 330 (0.91%)
    0 / 316 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 316 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    10 / 330 (3.03%)
    10 / 316 (3.16%)
         occurrences causally related to treatment / all
    8 / 10
    9 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    4 / 330 (1.21%)
    2 / 316 (0.63%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard Experimental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    327 / 330 (99.09%)
    306 / 316 (96.84%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm benign, malignant and unspecified
         subjects affected / exposed
    6 / 330 (1.82%)
    3 / 316 (0.95%)
         occurrences all number
    6
    3
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    11 / 330 (3.33%)
    4 / 316 (1.27%)
         occurrences all number
    11
    4
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    27 / 330 (8.18%)
    25 / 316 (7.91%)
         occurrences all number
    27
    25
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    9 / 330 (2.73%)
    9 / 316 (2.85%)
         occurrences all number
    9
    9
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    2 / 330 (0.61%)
    3 / 316 (0.95%)
         occurrences all number
    2
    3
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    2 / 330 (0.61%)
    0 / 316 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    82 / 330 (24.85%)
    60 / 316 (18.99%)
         occurrences all number
    82
    60
    Blood and lymphatic system disorders
    Blood & lymphatic system disorders/investigations
         subjects affected / exposed
    310 / 330 (93.94%)
    272 / 316 (86.08%)
         occurrences all number
    310
    272
    Gastrointestinal disorders
    Gastro-intestinal disorders
         subjects affected / exposed
    102 / 330 (30.91%)
    80 / 316 (25.32%)
         occurrences all number
    102
    80
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    16 / 330 (4.85%)
    7 / 316 (2.22%)
         occurrences all number
    16
    7
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    43 / 330 (13.03%)
    44 / 316 (13.92%)
         occurrences all number
    43
    44
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    14 / 330 (4.24%)
    9 / 316 (2.85%)
         occurrences all number
    14
    9
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    12 / 330 (3.64%)
    11 / 316 (3.48%)
         occurrences all number
    12
    11
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    19 / 330 (5.76%)
    17 / 316 (5.38%)
         occurrences all number
    19
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2011
    Addition of Data Safety Monitoring Committee Addition of quality of life questionnaire (QLQ-C30)
    15 May 2012
    Sponsor change (GELARC to CHU de Nancy) “GELARC” replaced by ”LYSARC” ; “GELA” replaced by “LYSA” reflecting change to names of these organizations
    13 Mar 2013
    Addition of neurological examination at each clinical examination Addition of instructions in case of PML suspicion following rituximab intake Updated AE part with addition of complementary information about expected toxicities Lumbar puncture at baseline not mandatory anymore. Optional and at the discretion of the investigator, except in cases of involvement of ovary, testis, breast or ORL and in the absence of clinical neurological signs Extension of inclusion period because of slower recruitment than expected
    08 Jul 2015
    Increase of number of patients to include in the study: addition of 230 patients Extension of recruitment period to reach 650 randomized patients Modification of an exclusion criteria to allow the inclusion of patient with HBV: Positive HIV, HBV and HCV serologies before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative). Patients with positive serology of hepatitis B virus (old disease) should be referred to a hepatologist or gastroenterologist before start of treatment and should be monitored and managed following local standards such as European Association of the Study of the Liver guidelines to prevent hepatitis reactivation. Updated list of PET reviewers Updated description of PET acquisition and reconstruction Modification of SAE reporting rules part to clarify the process Modification of informed consent part to remove the collection of third copy by LYSARC

    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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