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    Clinical Trial Results:
    A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL)

    Summary
    EudraCT number
    		 2019-001381-14
    Trial protocol
    		 CZ   GB   IT  
    Global end of trial date
    24 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2024
    First version publication date
    09 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VS-0145-229
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04038359
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Secura Bio, Inc.
    Sponsor organisation address
    1995 Village Center Circle, Suite 128, Las Vegas, NV, United States, 89134
    Public contact
    Ohad Bentur, MD, MHA, MSc/Senior Medical Director, Secura Bio, Inc., 1 702-254-0011, obentur@securabio.com
    Scientific contact
    Ohad Bentur, MD, MHA, MSc/Senior Medical Director, Secura Bio, Inc., 1 702-254-0011, obentur@securabio.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
    24 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of duvelisib administered with prescribed drug holidays in participants with iNHL, according to the 2007 revised International Working Group (IWG) Criteria.
    Protection of trial subjects
    This study was conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2019
    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
    Korea, Republic of: 23
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 15
    Worldwide total number of subjects
    103
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    57
    From 65 to 84 years
    45
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 One participant withdrew consent prior to receiving any study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duvelisib, Continuous and Intermittent Dosing
    Arm description
    		 Duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by 25 milligrams twice daily dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duvelisib
    Investigational medicinal product code
    Other name
    Copiktra, VS-0145, IPI-145
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Duvelisib was administered orally as a capsule at the dose and frequency described in the arm description.

    Arm title
    		 Duvelisib, Intermittent Dosing
    Arm description
    		 Duvelisib 25 milligrams twice daily dosed 2 weeks on and 2 weeks off.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duvelisib
    Investigational medicinal product code
    Other name
    Copiktra, VS-0145, IPI-145
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Duvelisib was administered orally as a capsule at the dose and frequency described in the arm description.

    Number of subjects in period 1 [1]
    		Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Started
    51
    51
    Received At Least 1 Dose of Study Drug
    51
    51
    Completed
    32
    36
    Not completed
    19
    15
         Participant moved
    1
    -
         Physician decision
    3
    2
         Consent withdrawn by subject
    4
    3
         Adverse event, non-fatal
    -
    2
         Death
    8
    7
         Lost to follow-up
    3
    -
         Progressive disease
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant in the 'Duvelisib, Continuous and Intermittent Dosing' study arm withdrew consent prior to receiving any study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Duvelisib, Continuous and Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by 25 milligrams twice daily dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.

    Reporting group title
    Duvelisib, Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily dosed 2 weeks on and 2 weeks off.

    Reporting group values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing Total
    Number of subjects
    		 51 51 102
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.5 ( 12.15 ) 63.9 ( 11.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 27 55
        Male
    		 23 24 47
    Race
    Units: Subjects
        Asian
    		 14 9 23
        White
    		 36 42 78
        Black or African American
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 48 50 98
        Not Reported
    		 2 0 2
        Unknown
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Duvelisib, Continuous and Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by 25 milligrams twice daily dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.

    Reporting group title
    Duvelisib, Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily dosed 2 weeks on and 2 weeks off.

    Subject analysis set title
    Modified Intent-to-treat (mITT)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All participants who receive at least 1 dose of duvelisib.

    Subject analysis set title
    All-treated (AT) Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who received at least 1 dose of study drug.

    Primary: Overall Response Rate (ORR) According to the 2007 Revised IWG Criteria

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    End point title
    		 Overall Response Rate (ORR) According to the 2007 Revised IWG Criteria [1]
    End point description
    ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Up to 14 months
    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 (percentage of participants plus confidence interval) are reported for this primary end point, as pre-specified in the statistical analysis plan.
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [2]
    51 [3]
    Units: percentage of participants
    number (confidence interval 95%)
        mITT
    65.3 (50.4 to 78.3)
    52.9 (38.5 to 67.1)
        PP
    62.2 (46.5 to 76.2)
    54.3 (39.0 to 69.1)
    Notes
    [2] - mITT (N=49); PP (N=45)
    [3] - mITT (N=51); PP (N=46)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date – treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography [PET-CT]) and progressive disease (according to computed tomography [CT]). Results reported as months. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [4]
    51 [5]
    Units: months
    median (confidence interval 95%)
        2007 Revised IWG Criteria
    16.0 (8.5 to 27.2)
    23.0 (12.5 to 34.3)
        2014 Lugano Criteria
    16.0 (8.5 to 27.2)
    23.0 (12.5 to 34.3)
    Notes
    [4] - mITT
    [5] - mITT
    No statistical analyses for this end point

    Secondary: ORR at Specific Timepoints

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    End point title
    		 ORR at Specific Timepoints
    End point description
    ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    6, 12, 18, and 24 months after first dose of study intervention
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [6]
    51 [7]
    Units: percentage of participants
    number (confidence interval 95%)
        6 months: 2007 Revised IWG Criteria
    63.3 (48.3 to 76.6)
    49.0 (34.8 to 63.4)
        12 months: 2007 Revised IWG Criteria
    65.3 (50.4 to 78.3)
    52.9 (38.5 to 67.1)
        18 months: 2007 Revised IWG Criteria
    65.3 (50.4 to 78.3)
    52.9 (38.5 to 67.1)
        24 months: 2007 Revised IWG Criteria
    65.3 (50.4 to 78.3)
    52.9 (38.5 to 67.1)
        6 months: 2014 Lugano Criteria
    63.3 (48.3 to 76.6)
    47.1 (32.9 to 61.5)
        12 months: 2014 Lugano Criteria
    65.3 (50.4 to 78.3)
    51.0 (36.6 to 65.2)
        18 months: 2014 Lugano Criteria
    65.3 (50.4 to 78.3)
    51.0 (36.6 to 65.2)
        24 months: 2014 Lugano Criteria
    65.3 (50.4 to 78.3)
    51.0 (36.6 to 65.2)
    Notes
    [6] - mITT
    [7] - mITT
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months. 9999=insufficient data available to generate summary-level data using prespecified method of analysis. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [8]
    51 [9]
    Units: months
    median (confidence interval 95%)
        2007 Revised IWG Criteria
    21.4 (13.7 to 9999)
    32.2 (17.5 to 9999)
        2014 Lugano Criteria
    21.4 (13.7 to 9999)
    32.2 (13.8 to 9999)
    Notes
    [8] - mITT
    [9] - mITT
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months. 9999=insufficient data available to generate summary-level data using prespecified method of analysis. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [10]
    51 [11]
    Units: months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Notes
    [10] - mITT
    [11] - mITT
    No statistical analyses for this end point

    Secondary: Lymph Node Response Rate (LNRR)

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    End point title
    		 Lymph Node Response Rate (LNRR)
    End point description
    LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    14 months
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [12]
    51 [13]
    Units: percentage of participants
        number (confidence interval 95%)
    64.3 (48.0 to 78.4)
    60.9 (45.4 to 74.9)
    Notes
    [12] - mITT
    [13] - mITT
    No statistical analyses for this end point

    Secondary: Time To First Response (TTFR)

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    End point title
    		 Time To First Response (TTFR)
    End point description
    For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR – randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 months
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    32 [14]
    27 [15]
    Units: months
    median (full range (min-max))
        2007 Revised IWG Criteria
    2.30 (2.1 to 12.9)
    2.30 (2.1 to 12.5)
        2014 Lugano Criteria
    2.30 (2.1 to 12.9)
    2.30 (2.1 to 12.5)
    Notes
    [14] - 2007 Revised IWG Criteria and 2014 Lugano Criteria: mITT (N=32)
    [15] - 2007 Revised IWG Criteria: mITT (N=27); 2014 Lugano Criteria: mITT (N=26)
    No statistical analyses for this end point

    Secondary: Time To Treatment Failure (TTF)

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    End point title
    		 Time To Treatment Failure (TTF)
    End point description
    TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months. Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [16]
    51 [17]
    Units: months
        median (confidence interval 95%)
    12.6 (6.2 to 17.1)
    14.3 (8.0 to 23.0)
    Notes
    [16] - mITT
    [17] - mITT
    No statistical analyses for this end point

    Secondary: ORR According to 2014 Lugano Criteria

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    End point title
    		 ORR According to 2014 Lugano Criteria
    End point description
    ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Here, ‘Number of subjects analyzed’ signifies those participants who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 months
    End point values
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Number of subjects analysed
    49 [18]
    51 [19]
    Units: percentage of participants
    number (confidence interval 95%)
        mITT
    65.3 (50.4 to 78.3)
    51.0 (36.6 to 65.2)
        PP
    62.2 (46.5 to 76.2)
    52.2 (36.9 to 67.1)
    Notes
    [18] - mITT (N=49); PP (N=45)
    [19] - mITT (N=51); PP (N=46)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 37 months
    Adverse event reporting additional description
    All reported safety data based upon All-treated (AT) Analysis Set: all participants who received at least 1 dose of duvelisib.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Duvelisib, Continuous and Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily continuously for 10 weeks, followed by 25 milligrams twice daily dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.

    Reporting group title
    Duvelisib, Intermittent Dosing
    Reporting group description
    		 Duvelisib 25 milligrams twice daily dosed 2 weeks on and 2 weeks off.

    Serious adverse events
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 51 (25.49%)
    16 / 51 (31.37%)
         number of deaths (all causes)
    8
    7
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pylorospasm
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COVID-19
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Duvelisib, Continuous and Intermittent Dosing Duvelisib, Intermittent Dosing
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 51 (96.08%)
    50 / 51 (98.04%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 51 (29.41%)
    8 / 51 (15.69%)
         occurrences all number
    61
    15
    Aspartate aminotransferase increased
         subjects affected / exposed
    15 / 51 (29.41%)
    6 / 51 (11.76%)
         occurrences all number
    55
    13
    Neutrophil count decreased
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 51 (3.92%)
         occurrences all number
    16
    4
    Platelet count decreased
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2
    Weight decreased
         subjects affected / exposed
    3 / 51 (5.88%)
    4 / 51 (7.84%)
         occurrences all number
    3
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    6 / 51 (11.76%)
         occurrences all number
    0
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    2
    4
    Headache
         subjects affected / exposed
    8 / 51 (15.69%)
    1 / 51 (1.96%)
         occurrences all number
    13
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 51 (7.84%)
    5 / 51 (9.80%)
         occurrences all number
    5
    7
    Neutropenia
         subjects affected / exposed
    10 / 51 (19.61%)
    17 / 51 (33.33%)
         occurrences all number
    19
    42
    Thrombocytopenia
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    3
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 51 (11.76%)
    1 / 51 (1.96%)
         occurrences all number
    12
    1
    Fatigue
         subjects affected / exposed
    7 / 51 (13.73%)
    5 / 51 (9.80%)
         occurrences all number
    11
    6
    Pyrexia
         subjects affected / exposed
    9 / 51 (17.65%)
    9 / 51 (17.65%)
         occurrences all number
    22
    11
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    4
    3
    Constipation
         subjects affected / exposed
    6 / 51 (11.76%)
    3 / 51 (5.88%)
         occurrences all number
    9
    3
    Diarrhoea
         subjects affected / exposed
    17 / 51 (33.33%)
    10 / 51 (19.61%)
         occurrences all number
    33
    16
    Nausea
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 51 (15.69%)
         occurrences all number
    10
    12
    Stomatitis
         subjects affected / exposed
    3 / 51 (5.88%)
    4 / 51 (7.84%)
         occurrences all number
    4
    4
    Vomiting
         subjects affected / exposed
    5 / 51 (9.80%)
    1 / 51 (1.96%)
         occurrences all number
    31
    1
    Dyspepsia
         subjects affected / exposed
    5 / 51 (9.80%)
    3 / 51 (5.88%)
         occurrences all number
    7
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 51 (5.88%)
         occurrences all number
    6
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 51 (7.84%)
    4 / 51 (7.84%)
         occurrences all number
    10
    4
    Rash
         subjects affected / exposed
    4 / 51 (7.84%)
    6 / 51 (11.76%)
         occurrences all number
    4
    7
    Rash maculo-papular
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Urticaria
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    6
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 51 (9.80%)
    0 / 51 (0.00%)
         occurrences all number
    5
    0
    Pain in extremity
         subjects affected / exposed
    4 / 51 (7.84%)
    4 / 51 (7.84%)
         occurrences all number
    4
    4
    Spinal pain
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 51 (15.69%)
    10 / 51 (19.61%)
         occurrences all number
    9
    11
    Pneumonia
         subjects affected / exposed
    2 / 51 (3.92%)
    5 / 51 (9.80%)
         occurrences all number
    4
    5
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 51 (5.88%)
         occurrences all number
    4
    4
    Urinary tract infection
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 51 (3.92%)
         occurrences all number
    6
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    5
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 51 (7.84%)
         occurrences all number
    1
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jan 2020
    • Added an optional tumor biopsy at Screening • Added Cycle 1, Day 43 visit, with hematology, concomitant medications, focused physical examination, vitals, adverse events, drug diary, and self-admin of drug • Clarified that only cases of overdose that cause a serious adverse event are required to be reported within 24 hours, and that Investigator will determine if and when dosing should resume • Modified inclusion/exclusion criteria
    18 May 2021
    • Removed Long-Term and Survival Follow Up visits, and revised study end date to be 2 years after last participant randomized • Removed all Progressive Disease/Biomarker sampling after Cycle 2

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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