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    Clinical Trial Results:
    A PHASE II TRIAL EVALUATING COMBINATION OF ATEZOLIZUMAB, WITH VENETOCLAX AND OBINUTUZUMAB FOR RELAPSED/REFRACTORY LYMPHOMAS

    Summary
    EudraCT number
    		 2016-005061-31
    Trial protocol
    		 FR  
    Global end of trial date
    24 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2025
    First version publication date
    25 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GATA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03276468
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LYSARC
    Sponsor organisation address
    165 chemin du grand revoyet, pierre-bénite, France, 69495
    Public contact
    Project Management , LYSARC, +33 472 66 93 33, gata@lysarc.org
    Scientific contact
    Project Management , LYSARC, +33 472 66 93 33, gata@lysarc.org
    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
    24 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to assess the anti-lymphoma activity of an anti-PD-L1 (atezolizumab) associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: - relapsed/refractory follicular lymphoma (FL) patients - relapsed/refractory aggressive (DLBCL) lymphoma patients - relapsed/refractory other indolent lymphoma patients
    Protection of trial subjects
    Corrective treatments possible
    Background therapy
    		 Prophylaxis and corrective treatments
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2017
    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
    France: 136
    Worldwide total number of subjects
    136
    EEA total number of subjects
    136
    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)
    100
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 58 patients were included in the GATA cohort 1 FL between the 19 February 2018 and the 26 November 2019. 58 patients were included in the GATA cohort 2 DLBCL between the 12 February 2018 and the 14 March 2019. 20 patients were included in the GATA cohort 3 between the 06 December 2018 and the 18 March 2020.

    Pre-assignment
    Screening details
    		 Safety run period: Twelve patients included in cohorts 1 or 2 who achieved 6 weeks (2 cycles) of treatment (4 doses of obinutuzumab, 2 doses of atezolizumab and 5 weeks of venetoclax) or having discontinued treatment were enrolled in their respective cohort for safety profile. If one of these 12 patients prematurely discontinued at least one o

    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
    		 Experimental
    Arm description
    		 Obinutuzumab 1000mg only at induction: Cycle: Day 1, Day 8 and Day 15 and at each Day 1 from cycle 2 to cycle8 Atezolizumab 1200mg at induction and maintenance: At each Day 2 from Cycle 1 to Cycle 24 Venetoclax at induction and maintenance: Given continuously from C1D8 to end of cycle 24 800mg/day for DLBCL and FL cohorts Step-up dose for iNHL cohort (50mg/d to 400mg/d over 4 weeks, then 800mg/d from week 5)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Injection
    Dosage and administration details
    1000mg IV at induction only: Cycle 1: Day 1, 8 and 15 then at each Day 1 from cycle 2 to cycle 8

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Infusion
    Dosage and administration details
    1200mg IV at each Day 2 from cycle 1 to cycle 24 (induction and maintenance phases)

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Given orally from Cycle 1 day 8 until end of cycle 24 (induction and maintenance phases). 800mg/day for DLBCL and FL cohorts. For iNHL cohort: From 50mg/d to 400mg/d over 4 weeks, then 800mg/d from week 5

    Number of subjects in period 1
    		Experimental
    Started
    136
    Completed
    136

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Obinutuzumab 1000mg only at induction: Cycle: Day 1, Day 8 and Day 15 and at each Day 1 from cycle 2 to cycle8 Atezolizumab 1200mg at induction and maintenance: At each Day 2 from Cycle 1 to Cycle 24 Venetoclax at induction and maintenance: Given continuously from C1D8 to end of cycle 24 800mg/day for DLBCL and FL cohorts Step-up dose for iNHL cohort (50mg/d to 400mg/d over 4 weeks, then 800mg/d from week 5)

    Reporting group values
    		 Experimental Total
    Number of subjects
    		 136 136
    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)
    		 100 100
        From 65-84 years
    		 36 36
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 136 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 80 80
    Subject analysis sets

    Subject analysis set title
    FAS FL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 1 is the FL cohort.

    Subject analysis set title
    FAS DLBCL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 2 is the DLBL cohort

    Subject analysis set title
    FAS iNHL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 3 is the iNHL cohort

    Subject analysis sets values
    		 FAS FL cohort FAS DLBCL cohort FAS iNHL cohort
    Number of subjects
    56
    55
    18
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    30
    20
    6
        From 65-84 years
    26
    34
    12
        85 years and over
    0
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.8 ( 10.74 )
    68.1 ( 10.81 )
    68.5 ( 9.48 )
    Gender categorical
    Units: Subjects
        Female
    19
    25
    8
        Male
    37
    30
    10

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Obinutuzumab 1000mg only at induction: Cycle: Day 1, Day 8 and Day 15 and at each Day 1 from cycle 2 to cycle8 Atezolizumab 1200mg at induction and maintenance: At each Day 2 from Cycle 1 to Cycle 24 Venetoclax at induction and maintenance: Given continuously from C1D8 to end of cycle 24 800mg/day for DLBCL and FL cohorts Step-up dose for iNHL cohort (50mg/d to 400mg/d over 4 weeks, then 800mg/d from week 5)

    Subject analysis set title
    FAS FL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 1 is the FL cohort.

    Subject analysis set title
    FAS DLBCL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 2 is the DLBL cohort

    Subject analysis set title
    FAS iNHL cohort
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Full Analysis Set (FAS) includes all patients having signed the informed consent and who received at least one dose of obinutuzumab, atezolizumab and venetoclax. The cohort 3 is the iNHL cohort

    Primary: Overall Response (CR + PR) Rate at End of Induction

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    End point title
    		 Overall Response (CR + PR) Rate at End of Induction
    End point description
    End point type
    Primary
    End point timeframe
    at End of Induction
    End point values
    		 FAS FL cohort FAS DLBCL cohort FAS iNHL cohort
    Number of subjects analysed
    56
    55
    18
    Units: percent
    number (confidence interval 90%)
        ORR
    53.6 (41.78 to 65.07)
    23.6 (14.58 to 34.93)
    66.7 (44.6 to 84.37)
    Statistical analysis title
    		 OMR and CR at end of induction
    Statistical analysis description
    end of induction
    Comparison groups
    FAS FL cohort v FAS DLBCL cohort v FAS iNHL cohort
    Number of subjects included in analysis
    129
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [1]
    P-value
    		 = 1 [2]
    Method
    		 t-test, 1-sided
    Parameter type
    		 Risk ratio (RR)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 70
    Variability estimate
    Standard deviation
    Notes
    [1] - end of induction
    [2] - No

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Immune-related AEs whatever the grade and AEs of grade ≥ 2 for other toxicities regardless relationship to investigational product occurring from the date of informed consent signature to 6 months after Last drug administration of the study for immune-..
    Adverse event reporting additional description
    for immune-related AEs and to 28 days after last drug administration of the study (obinutuzumab, atezolizumab or venetoclax) for other toxicities, will be recorded in the AE pages of the eCRF. During the initial safety analysis, where twelve patients (cohorts 1 & 2) will be enrolled and followed for 6 weeks of treatment, haematological toxicities.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety set C1
    Reporting group description
    		 Final Analysis Cohort 1, Safety set The Safety set includes all patients who received at least one dose of any study drug.

    Reporting group title
    Safety set C2
    Reporting group description
    		 Final Analysis Cohort 2, Safety set The Safety set includes all patients who received at least one dose of any study drug.

    Reporting group title
    Safety set C3
    Reporting group description
    		 Final Analysis Cohort 3, Safety set The Safety set includes all patients who received at least one dose of any study drug.

    Serious adverse events
    		 Safety set C1 Safety set C2 Safety set C3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 58 (29.31%)
    19 / 57 (33.33%)
    7 / 20 (35.00%)
         number of deaths (all causes)
    23
    47
    9
         number of deaths resulting from adverse events
    2
    0
    0
    Investigations
    BLOOD ELECTROLYTE ABNORMAL
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 58 (3.45%)
    2 / 57 (3.51%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 57 (3.51%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety set C1 Safety set C2 Safety set C3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 58 (96.55%)
    56 / 57 (98.25%)
    19 / 20 (95.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    30 / 58 (51.72%)
    24 / 57 (42.11%)
    13 / 20 (65.00%)
         occurrences all number
    78
    70
    45
    Lymphopenia
         subjects affected / exposed
    16 / 58 (27.59%)
    27 / 57 (47.37%)
    3 / 20 (15.00%)
         occurrences all number
    28
    49
    13
    Thrombocytopenia
         subjects affected / exposed
    14 / 58 (24.14%)
    20 / 57 (35.09%)
    6 / 20 (30.00%)
         occurrences all number
    22
    27
    13
    Anaemia
         subjects affected / exposed
    7 / 58 (12.07%)
    22 / 57 (38.60%)
    6 / 20 (30.00%)
         occurrences all number
    8
    37
    14
    Leukopenia
         subjects affected / exposed
    11 / 58 (18.97%)
    19 / 57 (33.33%)
    3 / 20 (15.00%)
         occurrences all number
    32
    47
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    20 / 58 (34.48%)
    6 / 57 (10.53%)
    6 / 20 (30.00%)
         occurrences all number
    22
    12
    8
    Nausea
         subjects affected / exposed
    7 / 58 (12.07%)
    7 / 57 (12.28%)
    3 / 20 (15.00%)
         occurrences all number
    7
    7
    4
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    19 / 58 (32.76%)
    9 / 57 (15.79%)
    1 / 20 (5.00%)
         occurrences all number
    29
    14
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2019
    Protocol amendment with change of the AESI list: addition of hemophagocytic lymphohistiocytosis and macrophage activation syndrome

    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
    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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