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    Clinical Trial Results:
    Phase II multicenter clinical trial to evaluate the efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin, and dexamethasone followed by ibrutinib as maintenance treatment in patients with refractory or relapsed non-treatment-resistant diffuse large B-cell lymphoma no candidates to receive a ASCT

    Summary
    EudraCT number
    		 2015-005390-21
    Trial protocol
    		 ES  
    Global end of trial date
    19 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2022
    First version publication date
    13 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IBDCL-GELTAMO-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02692248
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GELTAMO
    Sponsor organisation address
    C. de Fortuny, 51, Madrid, Spain, 28010
    Public contact
    Angel Cedillo, SecretarIa Cientifica GELTAMO, +34 913195780, sc@geltamo.com
    Scientific contact
    Angel Cedillo, SecretarIa Cientifica GELTAMO, +34 913195780, sc@geltamo.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 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of the combination (IR-GEMOX-dexa) as salvage treatment in patients with relapsing or refractory non-GCB-type DLBCL, in terms of overall response rate (ORR).
    Protection of trial subjects
    Study drug administration should be permanently discontinued in the event of toxicity lasting longer than 21 days, unless the center investigators consider that the benefit of continuing ibrutinib treatment outweighs the risk.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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
    Spain: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Initially 72 patients from 15 different hospitals were registered, 8 patients could not be considered analyzable since they were screening failures. Finally the analyzed population has 64 patients

    Pre-assignment
    Screening details
    		 Initially 72 patients from 15 different hospitals were registered, 8 patients could not be considered analyzable since they were screening failures. Finally the analyzed population has 64 patients

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

    Arms
    Arm title
    		 Full data analysis
    Arm description
    		 Subjects will receive Ibrutinib (Ib) with R-GEMOX-Dexa followed by Ib maintenance according to: Induction phase: Rituximab (R) 375 mg/m2 IV day 1 during 4 cycles; Gemcitabine (Gem) 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days; Oxaliplatine (Ox)100 mg/m2 on day 1 or 2 (after Gem adm.) 4 cycles every 14 days; Dex: 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days; Ib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days. Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Responsable person designated by the sponsor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Subjects will receive Ibrutinib (Ib) with R-GEMOX-Dexa followed by Ib maintenance according to: Induction phase: Rituximab (R) 375 mg/m2 IV day 1 during 4 cycles; Gemcitabine (Gem) 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days; Oxaliplatine (Ox)100 mg/m2 on day 1 or 2 (after Gem adm.) 4 cycles every 14 days; Dex: 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days; Ib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days. Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.

    Number of subjects in period 1
    		Full data analysis
    Started
    64
    Completed
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full data analysis
    Reporting group description
    		 -

    Reporting group values
    		 Full data analysis Total
    Number of subjects
    		 64 64
    Age categorical
    Units: Subjects
        >18
    		 64 64
    Age continuous
    Units: years
        median (standard deviation)
    		 62.57 ± 14.56 -
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 38 38
    ECOG-PS
    Units: Subjects
        ECOG 0
    		 23 23
        ECOG 1
    		 31 31
        ECOG 2
    		 10 10
    Diagnosis
    Units: Subjects
        DLBCL without specification
    		 60 60
        DLBCL rich in T lymphocytes
    		 3 3
        Follicular lymphoma
    		 1 1
    International prognostic index (IPI)
    Units: Subjects
        0-1
    		 6 6
        2-3
    		 43 43
        4-5
    		 13 13
        Unk
    		 2 2
    Disease stage at diagnosis
    Units: Subjects
        Stage I
    		 1 1
        Stage II
    		 9 9
        Stage III
    		 5 5
        Stage IV
    		 46 46
        Unk
    		 3 3
    LDH levels
    Units: Subjects
        Normal
    		 20 20
        Elevated
    		 42 42
        Unk
    		 2 2
    Previous lines of treatment
    Units: Previous lines of treatment
        median (full range (min-max))
    		 2 (1 to 5) -
    Subject analysis sets

    Subject analysis set title
    Full data analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects will receive Ibrutinib (Ib) with R-GEMOX-Dexa followed by Ib maintenance according to: Induction phase: Rituximab (R) 375 mg/m2 IV day 1 during 4 cycles; Gemcitabine (Gem) 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days; Oxaliplatine (Ox)100 mg/m2 on day 1 or 2 (after Gem adm.) 4 cycles every 14 days; Dex: 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days; Ib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days. Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.

    Subject analysis sets values
    		 Full data analysis
    Number of subjects
    64
    Age categorical
    Units: Subjects
        >18
    64
    Age continuous
    Units: years
        median (standard deviation)
    62.57 ± 14.56
    Gender categorical
    Units: Subjects
        Female
    26
        Male
    38
    ECOG-PS
    Units: Subjects
        ECOG 0
    23
        ECOG 1
    31
        ECOG 2
    10
    Diagnosis
    Units: Subjects
        DLBCL without specification
    60
        DLBCL rich in T lymphocytes
    3
        Follicular lymphoma
    1
    International prognostic index (IPI)
    Units: Subjects
        0-1
    6
        2-3
    43
        4-5
    13
        Unk
    2
    Disease stage at diagnosis
    Units: Subjects
        Stage I
    1
        Stage II
    9
        Stage III
    5
        Stage IV
    46
        Unk
    3
    LDH levels
    Units: Subjects
        Normal
    20
        Elevated
    42
        Unk
    2
    Previous lines of treatment
    Units: Previous lines of treatment
        median (full range (min-max))
    2 (1 to 5)

    End points

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    End points reporting groups
    Reporting group title
    Full data analysis
    Reporting group description
    		 Subjects will receive Ibrutinib (Ib) with R-GEMOX-Dexa followed by Ib maintenance according to: Induction phase: Rituximab (R) 375 mg/m2 IV day 1 during 4 cycles; Gemcitabine (Gem) 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days; Oxaliplatine (Ox)100 mg/m2 on day 1 or 2 (after Gem adm.) 4 cycles every 14 days; Dex: 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days; Ib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days. Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.

    Subject analysis set title
    Full data analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects will receive Ibrutinib (Ib) with R-GEMOX-Dexa followed by Ib maintenance according to: Induction phase: Rituximab (R) 375 mg/m2 IV day 1 during 4 cycles; Gemcitabine (Gem) 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days; Oxaliplatine (Ox)100 mg/m2 on day 1 or 2 (after Gem adm.) 4 cycles every 14 days; Dex: 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days; Ib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days. Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.

    Primary: Overall Response (OR) Rate (Complete Remission + Partial Response)

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    End point title
    		 Overall Response (OR) Rate (Complete Remission + Partial Response) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment responses will be evaluated 30 days after end of study treatment wich can be ocurred after 2 years and 4 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: this is a single arm trial
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: Percentage of patients presented CR+PR
    36
    No statistical analyses for this end point

    Secondary: CR Rate During Induction and Maintenance Phases.

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    End point title
    		 CR Rate During Induction and Maintenance Phases.
    End point description
    Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: percentage of the patients presented CR
    25
    No statistical analyses for this end point

    Secondary: Response duration

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    End point title
    		 Response duration
    End point description
    Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease.
    End point type
    Secondary
    End point timeframe
    Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months.
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: months
        median (full range (min-max))
    6.5 (0.0 to 38.3)
    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 defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease
    End point type
    Secondary
    End point timeframe
    Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: months
        median (confidence interval 95%)
    4.1 (2.2 to 6.1)
    No statistical analyses for this end point

    Secondary: Event-free Survival

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    End point title
    		 Event-free Survival
    End point description
    Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Full data analysis
    Number of subjects analysed
    63 [2]
    Units: months
        median (confidence interval 95%)
    4.03 (2.5 to 5.6)
    Notes
    [2] - pts with new neoplasia, not required new therapeutic strategy and was not considered as an EFS event
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: months
        median (confidence interval 95%)
    11.67 (7 to 16.3)
    No statistical analyses for this end point

    Secondary: Safety and Tolerability of Ibrutinib in Combination Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone

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    End point title
    		 Safety and Tolerability of Ibrutinib in Combination Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone
    End point description
    Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC. Unist: Percentage of patients that present AE related to the treatment
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Full data analysis
    Number of subjects analysed
    64
    Units: Percentage of patients that present AE
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Deberán registrarse en el CRD todos los acontecimientos adversos ocurridos durante la realización del ensayo clínico (en el caso de AAG desde la firma del consentimiento informado) y hasta 30 días después de la última dosis de la medicación del estudio.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 64 (51.56%)
         number of deaths (all causes)
    46
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal tumor grade 4
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Tumor lysis syndrome - Grade 4
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    fracture grade 3
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Hip fracture grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Patient took expired medication grade Unknown
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Subarachnoid hemorrhage - Grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Heart failure - Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Hypotension grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Pericardial tamponade - Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Pericarditis - Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Akathisia Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Confusion grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Transient ischemic attacks - Grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia - Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia - Grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia - Grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Hematoma - Grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Back pain grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    fatigue grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    fever grade 1
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    fever grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    fever grade 3
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Flu like symptoms grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Clinical deterioration Grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Malaise Grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Pain grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea grade 3
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Dysphagia grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Vomiting grade 2
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Vomiting grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure grade 3
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Partial Respiratory failure grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Herpes zoster grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    candidiasis grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Lung infection grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Lung infection grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Sepsis grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Septic shock grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    upper respiratory infection grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory infection grade 5
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection grade 3
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection grade 4
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 64 (98.44%)
    Nervous system disorders
    Paresthesia
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    0
    Neutrophil count decreased
         subjects affected / exposed
    22 / 64 (34.38%)
         occurrences all number
    0
    Platelet count decreased
         subjects affected / exposed
    39 / 64 (60.94%)
         occurrences all number
    0
    Lymphocyte count decreased
         subjects affected / exposed
    10 / 64 (15.63%)
         occurrences all number
    0
    Hypomagnesemia
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    0
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    0
    Fatigue
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    20 / 64 (31.25%)
         occurrences all number
    0
    Vomiting
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2016
    Modification of the title of the trial due to a typographical error.
    31 Jan 2017
    Modifications corresponding to the Patient Information and Informed Consent, as a result of the update of the safety aspects reflected in the new edition of the IB of IBRUTINIB and the IBRUTINIB data sheet.
    19 Sep 2020
    Change of the principal investigator of the study at a Hospital and safety changes included in the new IB of Ibrutinib that apply to HIP-CI.

    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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