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    Clinical Trial Results:
    A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion

    Summary
    EudraCT number
    		 2013-003314-41
    Trial protocol
    		 AT   GB   PT   HU   IT   BE   CZ   DK   ES   PL  
    Global end of trial date
    17 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2017
    First version publication date
    15 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-312-0133
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02044822
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    17 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Aug 2014
    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
    Poland: 15
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    Australia: 6
    Worldwide total number of subjects
    102
    EEA total number of subjects
    77
    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)
    41
    From 65 to 84 years
    58
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 06 August 2014. The last study visit occurred on 17 May 2016.

    Pre-assignment
    Screening details
    		 130 participants were screened.

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

    Arms
    Arm title
    		 Idelalisib + Rituximab
    Arm description
    		 Idelalisib continuously throughout the study (up to 10 years) + rituximab for 8 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idelalisib
    Investigational medicinal product code
    Other name
    Zydelig®, GS-1101, CAL-101
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg administered twice daily

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Rituxan, Mabthera
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m^2 once weekly

    Number of subjects in period 1
    		Idelalisib + Rituximab
    Started
    102
    Completed
    9
    Not completed
    93
         Withdrew Consent
    3
         Initiation of Anti-Neoplastic Therapy
    2
         Investigator's Discretion
    10
         Study Terminated by Sponsor
    77
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Idelalisib + Rituximab
    Reporting group description
    		 Idelalisib continuously throughout the study (up to 10 years) + rituximab for 8 weeks

    Reporting group values
    		 Idelalisib + Rituximab Total
    Number of subjects
    		 102 102
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 58 58
    Race
    Units: Subjects
        Asian
    		 2 2
        Black or African American
    		 2 2
        White
    		 94 94
        Not Permitted
    		 4 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6 6
        Not Hispanic or Latino
    		 91 91
        Not Permitted
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Idelalisib + Rituximab
    Reporting group description
    		 Idelalisib continuously throughout the study (up to 10 years) + rituximab for 8 weeks

    Primary: Overall Response Rate

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    End point title
    		 Overall Response Rate [1]
    End point description
    Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC). Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Primary
    End point timeframe
    Not applicable
    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: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [2]
    Units: Not applicable
    Notes
    [2] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [3]
    Units: Not applicable
    Notes
    [3] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Nodal Response Rate

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    End point title
    		 Nodal Response Rate
    End point description
    Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC. Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [4]
    Units: Not applicable
    Notes
    [4] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Complete Response Rate

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    End point title
    		 Complete Response Rate
    End point description
    Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC. Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [5]
    Units: Not applicable
    Notes
    [5] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival

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    End point title
    		 Progression-Free Survival
    End point description
    Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC. Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [6]
    Units: Not applicable
    Notes
    [6] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the interval from the start of study treatment to death from any cause. Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [7]
    Units: Not applicable
    Notes
    [7] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Minimal Residual Disease Negativity Rate at Week 36

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    End point title
    		 Minimal Residual Disease Negativity Rate at Week 36
    End point description
    Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab. Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    End point type
    Secondary
    End point timeframe
    Not applicable
    End point values
    		 Idelalisib + Rituximab
    Number of subjects analysed
    0 [8]
    Units: Not applicable
    Notes
    [8] - Analysis was not performed due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 17 months plus 30 days
    Adverse event reporting additional description
    ITT Analysis Set; NOTE: Serious adverse events and deaths causally related to “treatment” refers to events deemed related to idelalisib treatment per investigator assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Idelalisib + Rituximab
    Reporting group description
    		 Idelalisib continuously throughout the study (up to 10 years) + rituximab for 8 weeks

    Serious adverse events
    		 Idelalisib + Rituximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 102 (45.10%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    11 / 102 (10.78%)
         occurrences causally related to treatment / all
    8 / 15
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hiccups
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Laryngeal pain
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Body temperature increased
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transaminases increased
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 102 (2.94%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glossitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral mucosal eruption
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal sepsis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection fungal
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 102 (4.90%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyslipidaemia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    4 / 102 (3.92%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Idelalisib + Rituximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 102 (96.08%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 102 (6.86%)
         occurrences all number
    7
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    15 / 102 (14.71%)
         occurrences all number
    18
    Chills
         subjects affected / exposed
    13 / 102 (12.75%)
         occurrences all number
    13
    Fatigue
         subjects affected / exposed
    16 / 102 (15.69%)
         occurrences all number
    20
    Oedema peripheral
         subjects affected / exposed
    11 / 102 (10.78%)
         occurrences all number
    12
    Pyrexia
         subjects affected / exposed
    24 / 102 (23.53%)
         occurrences all number
    34
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 102 (18.63%)
         occurrences all number
    25
    Dyspnoea
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    9
    Epistaxis
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 102 (6.86%)
         occurrences all number
    7
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    39 / 102 (38.24%)
         occurrences all number
    58
    Aspartate aminotransferase increased
         subjects affected / exposed
    22 / 102 (21.57%)
         occurrences all number
    33
    Transaminases increased
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    11
    Weight decreased
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    9
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    9
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    9
    Headache
         subjects affected / exposed
    10 / 102 (9.80%)
         occurrences all number
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 102 (13.73%)
         occurrences all number
    21
    Neutropenia
         subjects affected / exposed
    24 / 102 (23.53%)
         occurrences all number
    33
    Thrombocytopenia
         subjects affected / exposed
    10 / 102 (9.80%)
         occurrences all number
    13
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    15 / 102 (14.71%)
         occurrences all number
    18
    Diarrhoea
         subjects affected / exposed
    36 / 102 (35.29%)
         occurrences all number
    67
    Dyspepsia
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    8
    Mouth ulceration
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    19 / 102 (18.63%)
         occurrences all number
    23
    Vomiting
         subjects affected / exposed
    17 / 102 (16.67%)
         occurrences all number
    21
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    10
    Rash
         subjects affected / exposed
    28 / 102 (27.45%)
         occurrences all number
    35
    Rash maculo-papular
         subjects affected / exposed
    7 / 102 (6.86%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    9
    Back pain
         subjects affected / exposed
    10 / 102 (9.80%)
         occurrences all number
    10
    Myalgia
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    8
    Pain in extremity
         subjects affected / exposed
    8 / 102 (7.84%)
         occurrences all number
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    6
    Nasopharyngitis
         subjects affected / exposed
    10 / 102 (9.80%)
         occurrences all number
    12
    Oral candidiasis
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    6
    Respiratory tract infection
         subjects affected / exposed
    6 / 102 (5.88%)
         occurrences all number
    6
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 102 (6.86%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 102 (8.82%)
         occurrences all number
    10
    Hypokalaemia
         subjects affected / exposed
    10 / 102 (9.80%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2014
    Revisions made to address VHP concerns with the GS-US-312-0123 protocol and to align with global changes made to all protocols in the idelalisib (IDELA) frontline CLL program.
    07 Nov 2014
    The protocol was revised primarily to align with IDELA Investigator’s Brochure (IB) Edition 11 and to align with global changes made to all protocols in the idelalisib (IDELA) frontline CLL program.
    25 Nov 2014
    The protocol was revised primarily to update the creatinine clearance value required prior to entry into the study. This change is being made to correct an error in Amendment 2, where the value was incorrectly changed. The criteria of ≥ 30 mL/min should not have changed from Amendment 1.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Mar 2016
    An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
    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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