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    Clinical Trial Results:
    A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin and Venetoclax in Patie.nts With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    Summary
    EudraCT number
    		 2016-002480-34
    Trial protocol
    		 DE  
    Global end of trial date
    30 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BH39147
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03135262
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann- La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global-roche-genentech-trials@gene.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
    08 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice (GCP) guidelines according to the regulations and procedures described in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 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
    Australia: 6
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    29
    EEA total number of subjects
    5
    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)
    11
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 29 Subjects (ITT population) were enrolled at 13 sites in the USA, Australia, South Korea, New Zealand and Germany during the dose escalation phase. 1 subject was undefined as the diagnosis at study entry was not provided.

    Pre-assignment
    Screening details
    		 The study was prematurely terminated after Escalation Phase because of the overall modest benefit achieved with MTD during the escalation phase. In each DLBCL and FL arm, subjects are in Safety Cohort, Cohort 1, Cohort 2, Cohort 3 and Cohort 3- Not defined (DLBCL only). All Adverse Events are reported per Cohort rather than per Arm.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose Escalation DLBCL and FL Safety Cohort
    Arm description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation

    Arm title
    		 Dose Escalation DLBCL and FL Cohort 1
    Arm description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation

    Arm title
    		 Dose Escalation DLBCL and FL Cohort 2
    Arm description
    		 Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 150 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation

    Arm title
    		 Dose Escalation DLBCL and FL Cohort 3
    Arm description
    		 Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 milligrams (mg) idasanutlin orally, once daily for 5 days, every 28 days, until treatment discontinuation

    Arm title
    		 Not Defined DLBCL only Cohort 3
    Arm description
    		 Not defined
    Arm type
    		 Experimental

    Investigational medicinal product name
    Not defined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Not defined

    Number of subjects in period 1
    		Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Started
    9
    6
    7
    6
    1
    Completed
    0
    0
    0
    0
    0
    Not completed
    9
    6
    7
    6
    1
         Adverse event, serious fatal
    6
    2
    2
    2
    -
         Consent withdrawn by subject
    -
    -
    1
    -
    1
         Discontinued due to pre-existing medical condition
    1
    -
    -
    -
    -
         Study terminated by sponsor
    2
    4
    4
    3
    -
         Progression of disease
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dose Escalation DLBCL and FL Safety Cohort
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 1
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 2
    Reporting group description
    		 Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 3
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg

    Reporting group title
    Not Defined DLBCL only Cohort 3
    Reporting group description
    		 Not defined

    Reporting group values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3 Total
    Number of subjects
    		 9 6 7 6 1 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 6 2 2 0 1 11
        From 65-84 years
    		 3 4 5 6 0 18
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.6 ( 15.5 ) 68.5 ( 8.7 ) 72.4 ( 8.6 ) 74.3 ( 5.5 ) 25.0 ( 999 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 3 3 3 3 0 12
        Male
    		 6 3 4 3 1 17
    Race (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 9 6 7 6 1 29
        Hispanic or Latino
    		 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Asian
    		 2 0 1 2 0 5
        White
    		 7 5 6 2 1 21
        Black or African American
    		 0 0 0 1 0 1
        Unknown
    		 0 1 0 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Dose Escalation DLBCL and FL Safety Cohort
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 1
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 2
    Reporting group description
    		 Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 3
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg

    Reporting group title
    Not Defined DLBCL only Cohort 3
    Reporting group description
    		 Not defined

    Primary: RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab

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    End point title
    		 RP2D of Idasanutlin When Given in Combination With Obinutuzumab or Rituximab [1]
    End point description
    It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. phases. The study was closed because at escalation doses 100 and 150 mg Idasanutlin, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts. The subpopulations of DLBCL and FL were showed no difference in their genetic subtype make-up, therefore, Cohorts Safety, 1, 2, 3 contain both populations.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)
    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 descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: mg
        number (not applicable)
    0
    0
    150
    100
    0
    No statistical analyses for this end point

    Primary: RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab

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    End point title
    		 RP2D of Venetoclax When Given in Combination With Obinutuzumab or Rituximab [2]
    End point description
    It was planned to be identified in escalation and carried over in expansion phases. However the expansion phase did not take place. The study was closed because at escalation doses 200 and 400 mg Venetoclax, the benefit was mild. The study was terminated at the escalation phase with DLTs showing AEs in all cohorts.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)
    Notes
    [2] - 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 descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: mg
    0
    0
    200
    400
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Dose-Limiting Toxicities (DLTs)

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    End point title
    		 Percentage of Subjects With Dose-Limiting Toxicities (DLTs) [3]
    End point description
    DLT is defined as any one of the following events occurring during first two Cycles of treatment and assessed by the investigator as clearly not related to patient's underlying disease: - Any Grade 5 adverse event (AE) unless unequivocally due to the underlying malignancy or extraneous causes; - AE of any grade that leads to a delay of more than 14 days at the start of next treatment cycle; - Hematologic AEs (neutropenia, thrombocytopenia); - Non-hematologic AE, except IRRs, laboratory TLS without manifestations of clinical TLS, AST or ALT, diarrhea, nausea or vomiting, fatigue, asthenia, anorexia, or constipation, hepatic transaminase.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 up to Cycle 2 Day 28 (each cycle = 28 days)
    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 descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: Percentage of Subjects
        number (not applicable)
    0
    16.7
    28.6
    16.7
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) [4]
    End point description
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a casual relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
    End point type
    Primary
    End point timeframe
    From Baseline up to approximately 48 months
    Notes
    [4] - 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 descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: Percentage of Subjects
        number (not applicable)
    100
    100
    100
    100
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Complete Response (CR), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography-Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With Complete Response (CR), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography-Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria [5]
    End point description
    The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Part II), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Part I). Therefore the result data not derived and not reported.
    End point type
    Primary
    End point timeframe
    At end of Induction (EOI) (within 6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days])
    Notes
    [5] - 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 descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    Units: Percentage of Subjects
        number (not applicable)
    Notes
    [6] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [7] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [8] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [9] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [10] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With CR, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
    End point description
    The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based complete response (CR), which required a complete metabolic response with a score of 1, 2 or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [<=] mediastinum; 3 = uptake greater than [>] mediastinum and <= liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if intermediate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: Percentage of Subjects
        number (confidence interval 90%)
    22.2 (4.10 to 54.96)
    16.7 (0.85 to 58.18)
    28.6 (5.34 to 65.87)
    16.7 (0.85 to 58.18)
    0 (0 to 95.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CR, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With CR, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria
    End point description
    The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required to complete radiologic response with all of the following: target nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion [LDi]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. Therefore the result data not derived and not reported.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    Units: Percentage of Subjects
    Notes
    [11] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [12] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [13] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [14] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [15] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With CR, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With CR, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria
    End point description
    The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimeters in the longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who received at least 2 cycles of Induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. This outcome measure therefore not derived and not reported.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    Units: Percentage of Subjects
    Notes
    [16] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [17] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [18] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [19] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [20] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response, Determined by the IRC on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With Objective Response, Determined by the IRC on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
    End point description
    The IRC was to evaluate responses at the end of induction treatment using Luagno 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2 or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. The study was pre-maturely terminated.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: Percentage of Subjects
    Notes
    [21] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [22] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [23] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [24] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [25] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects with Objective Response, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
    End point description
    The investigator was to evaluate responses at end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. The study was terminated after escalation phase and no result data derived.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: Percentage of Subjects
        number (confidence interval 90%)
    33.3 (9.77 to 65.51)
    16.7 (0.85 to 58.18)
    28.6 (5.34 to 65.87)
    33.3 (6.28 to 72.87)
    0 (0 to 95.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With Objective Response, Determined by the IRC on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria
    End point description
    The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/nomal, regressed, but no increase; and spleen must have regressed by >50% in length. Because of early termination, no result data derived.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    Units: Percentage of Subjects
    Notes
    [26] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [27] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [28] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [29] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [30] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response at EOI, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With Objective Response at EOI, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria
    End point description
    The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. Because of early termination, the result did not derive.
    End point type
    Secondary
    End point timeframe
    At EOI (6 to 8 weeks after Cycle 6 Day 1 [up to approximately 28 weeks] [each cycle = 28 days]
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    Units: Percentage of Subjects
    Notes
    [31] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [32] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [33] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [34] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [35] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria

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    End point title
    		 Percentage of Subjects With Objective Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Modified Lugano 2014 Criteria
    End point description
    The investigator was to evaluate responses during the study treatment using Luagno 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a >=50% decrease in sum of the product of perpendicular diameters up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. Because of early termination, the result did not derive.
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    Units: Percentage of Subjects
    Notes
    [36] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [37] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [38] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [39] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    [40] - The study was terminated after escalation phase due to mile benefit by the sponsor's decision.
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration of Obinutuzumab in Subjects With FL

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    End point title
    		 Observed Serum Concentration of Obinutuzumab in Subjects With FL
    End point description
    Observed Serum Concentration of Obinutuzumab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported. The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study.
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: mg
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration of Obinutuzumab in Subjects With DLBCL

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    End point title
    		 Observed Serum Concentration of Obinutuzumab in Subjects With DLBCL
    End point description
    Observed Serum Concentration of Obinutuzumab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
    End point type
    Secondary
    End point timeframe
    Induction: Pre-dose (any time prior to dose on same day) and 30 min post-dose on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) and 30 min post-dose on Day 1 of Cycles 2, 4 and 6 (each cycle = 28 days)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration of Rituximab in Subjects With FL

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    End point title
    		 Observed Serum Concentration of Rituximab in Subjects With FL
    End point description
    Observed Serum Concentration of Rituximab in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
    End point type
    Secondary
    End point timeframe
    Induction: Pre-dose (any time prior to dose on same day) on Day 1 of Cycle 1; Pre-dose (within 5 hrs prior to dose) on Day 1 of Cycles 2, 4, 6; 30 min post-dose on Day 1 of Cycles 1 and 6 (each cycle = 28 days)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Serum Concentration of Rituximab in Subjects With DLBCL

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    End point title
    		 Observed Serum Concentration of Rituximab in Subjects With DLBCL
    End point description
    Observed Serum Concentration of Rituximab in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived, therefore no result was reported.
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 (cycle length = 28 days) up to approximately 48 months (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Plasma Concentration of Idasanutlin in Subjects With FL

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    End point title
    		 Observed Plasma Concentration of Idasanutlin in Subjects With FL
    End point description
    Observed Plasma Concentration of Idasanutlin in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Plasma Concentration of Idasanutlin in Subjectss With DLBCL

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    End point title
    		 Observed Plasma Concentration of Idasanutlin in Subjectss With DLBCL
    End point description
    Observed Plasma Concentration of Idasanutlin in Participants With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated. No result data was derived therefore no result was reported
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Plasma Concentration of Venetoclax in Subjects With FL

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    End point title
    		 Observed Plasma Concentration of Venetoclax in Subjects With FL
    End point description
    Observed Plasma Concentration of Venetoclax in Participants With FL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated.
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Plasma Concentration of Venetoclax in Subjects With DLBCL

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    End point title
    		 Observed Plasma Concentration of Venetoclax in Subjects With DLBCL
    End point description
    Observed Plasma Concentration of Venetoclax in Subjects With DLBCL was planned to be determined as part of the pharmacokinetics analyses during the expansion phase which did not take place. The study was prematurely terminated because of the overall modest benefit achieved with MTD during the escalation phase (Part 1); Phase II of the study (expansion) was never initiated.
    End point type
    Secondary
    End point timeframe
    From Day 1 of Cycle 1 up to Day 5 of Cycle 4 (each cycle = 28 days) (detailed timeframe is mentioned in outcome measure description)
    End point values
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 Not Defined DLBCL only Cohort 3
    Number of subjects analysed
    9
    6
    7
    6
    1
    Units: pg/ml
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline until after the last dose of study drug treatment
    Adverse event reporting additional description
    Reported: Safety Population. During the Safety Follow-up Period, non-Serious Adverse Events occurred at the 5% frequency threshold. There was no non-SAEs occurred reported in Dose Escalation DLBCL only Cohort 3 Not Defined arm.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Dose Escalation DLBCL and FL Safety Cohort
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 1
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 2
    Reporting group description
    		 Idasanutlin 150 mg + Venetoclax 200 mg + Obinutuzumab 1000 mg

    Reporting group title
    Dose Escalation DLBCL and FL Cohort 3
    Reporting group description
    		 Idasanutlin 100 mg + Venetoclax 400 mg + Obinutuzumab 1000 mg

    Reporting group title
    DLBCL Only Not Defined Cohort
    Reporting group description
    		 Not defines

    Serious adverse events
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 DLBCL Only Not Defined Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 6 (50.00%)
    4 / 7 (57.14%)
    4 / 6 (66.67%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    6
    2
    2
    2
    0
         number of deaths resulting from adverse events
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSAMINASES INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    INFUSION RELATED REACTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    DEVICE RELATED INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dose Escalation DLBCL and FL Safety Cohort Dose Escalation DLBCL and FL Cohort 1 Dose Escalation DLBCL and FL Cohort 2 Dose Escalation DLBCL and FL Cohort 3 DLBCL Only Not Defined Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    6 / 6 (100.00%)
    7 / 7 (100.00%)
    6 / 6 (100.00%)
    0 / 1 (0.00%)
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    FLUSHING
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    HYPOTENSION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    LYMPHATIC FISTULA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    THROMBOPHLEBITIS SUPERFICIAL
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 6 (50.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    CHILLS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    FATIGUE
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 6 (50.00%)
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    1
    3
    3
    1
    0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    OEDEMA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    PYREXIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    UNEVALUABLE EVENT
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    EPISTAXIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    LOWER RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    DELIRIUM
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    DEPRESSION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    INSOMNIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    ALANINE AMINOTRANSFERASE
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    AMYLASE INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    1
    1
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    RESPIROVIRUS TEST POSITIVE
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    SERUM FERRITIN INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    5
    7
    0
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    CONTUSION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    INFUSION RELATED REACTION
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    MEDICATION ERROR
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    PRODUCT ADMINISTRATION ERROR
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    PRODUCT DOSE OMISSION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    SKIN ABRASION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    WOUND COMPLICATION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    1
    0
    0
    HEADACHE
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    5
    2
    2
    1
    0
    NEURALGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    PARAESTHESIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    RADICULAR PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    SYNCOPE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    4 / 9 (44.44%)
    1 / 6 (16.67%)
    4 / 7 (57.14%)
    3 / 6 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    1
    4
    6
    0
    LEUKOPENIA
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 6 (16.67%)
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    8
    1
    0
    LYMPHOPENIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    NEUTROPENIA
         subjects affected / exposed
    7 / 9 (77.78%)
    5 / 6 (83.33%)
    7 / 7 (100.00%)
    5 / 6 (83.33%)
    0 / 1 (0.00%)
         occurrences all number
    13
    8
    20
    21
    0
    THROMBOCYTOPENIA
         subjects affected / exposed
    7 / 9 (77.78%)
    4 / 6 (66.67%)
    7 / 7 (100.00%)
    5 / 6 (83.33%)
    0 / 1 (0.00%)
         occurrences all number
    9
    5
    13
    6
    0
    Eye disorders
    EYE DISORDER
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    EYE PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    PHOTOPHOBIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    VISION BLURRED
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    ANAL INCONTINENCE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    CONSTIPATION
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    2
    0
    DIARRHOEA
         subjects affected / exposed
    5 / 9 (55.56%)
    3 / 6 (50.00%)
    4 / 7 (57.14%)
    4 / 6 (66.67%)
    0 / 1 (0.00%)
         occurrences all number
    9
    3
    6
    10
    0
    DYSPEPSIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    FLATULENCE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    MOUTH ULCERATION
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    NAUSEA
         subjects affected / exposed
    6 / 9 (66.67%)
    4 / 6 (66.67%)
    3 / 7 (42.86%)
    3 / 6 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    14
    6
    3
    8
    0
    ODYNOPHAGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    STOMATITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    TONGUE HAEMATOMA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    VOMITING
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    5
    3
    1
    2
    0
    Skin and subcutaneous tissue disorders
    ERYTHEMA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    ERYTHEMA AB IGNE
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    NIGHT SWEATS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    PAIN OF SKIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    RASH
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    DYSURIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    HAEMATURIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    MICTURITION URGENCY
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    URINARY RETENTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Endocrine disorders
    HYPERTHYROIDISM
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    BACK PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    BONE PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    FLANK PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    JOINT STIFFNESS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    MYALGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    0
    1
    0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    VERTEBRAL FORAMINAL STENOSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    CELLULITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    GASTROENTERITIS NOROVIRUS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    HERPES ZOSTER
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    MUCOSAL INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    SINUSITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    WOUND INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    GOUT
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    HYPERCALCAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    HYPOPHAGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    TUMOUR LYSIS SYNDROME
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    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.
    Dose expansion part of the study did not take place. AEs were not differentiated for DLBCL and FL arms since these are sub mutations of disease which does nor show differences in AEs.
    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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