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    Clinical Trial Results:
    Single arm NCRI feasibility study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter’s Syndrome

    Summary
    EudraCT number
    		 2009-016459-23
    Trial protocol
    		 GB  
    Global end of trial date
    19 Apr 2016

    Results information
    Results version number
    		 v1
    This version publication date
    10 May 2017
    First version publication date
    10 May 2017
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    OCTO_018
    Additional study identifiers
    ISRCTN number
    		 ISRCTN88860946
    US NCT number
    		 NCT01171378
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Joint Research Office, Block 60, Churchill Hospital, Old Road, Oxford, United Kingdom, OX3 7LE
    Public contact
    Heather House, University of Oxford, +44 1865 572245, ctrg@admin.ox.ac.uk
    Scientific contact
    Heather House, University of Oxford, +44 1865 572245, ctrg@admin.ox.ac.uk
    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
    02 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine objective response to ofatumumab plus CHOP at week 13, week 20 and week 72 as measured from start of treatment according to the Revised Response Criteria for Malignant Lymphoma. In other words, the purpose of the trial is to find out if the addition of Ofatumumab to standard chemotherapy treatment is better (more patients living longer) than the standard chemotherapy alone.
    Protection of trial subjects
    The trial received ethical and regulatory approval, and was run in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, and amendments thereafter, the guidelines for Good Clinical Practice, and the applicable policies of the Sponsor, the University of Oxford. Together, these regulations implement the ethical principles of the Declaration of Helsinki (1996) and the regulatory requirements for clinical trials of an investigational medicinal product as set out in the European Union (EU) Directive.
    Background therapy
    		 As well as Ofatumumab, all patients will be treated with up to a maximum of six three-weekly cycles of CHOP chemotherapy. This consists of: cyclophosphamide 750 mg/m2 intravenous (iv) bolus, doxorubicin 50 mg/m2 iv bolus, vincristine 1.4 mg/m2 (maximum 2 mg or 1 mg in patients over 70 years old) iv infusion in 50 ml sodium chloride 0.9% over 10 minutes, prednisolone 40 mg/m2 orally od, on day one and prednisolone 40 mg/ m2 orally od on days 2–5 of each cycle. CHOP chemotherapy is not regarded as an IMP as it is standard care and all patients will be treated the same.
    Evidence for comparator
    		 No comparator used - single arm study.
    Actual start date of recruitment
    27 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    19
    From 65 to 84 years
    21
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 43 patients were recruited across 10 active sites in UK. The first patient was recruited on 05May2011 and the last patient was recruited on 01Dec2014.

    Pre-assignment
    Screening details
    		 Screened 48 patients. Eligible if >18, ECOG PS 0-3, known diagnosis of B-CLL and newly diagnosed, untreated and biopsy proven DLBCL Richter's transformation according to WHO classification. Not eligible if previously treated with anthracycline-containing treatment for DLBCL within six months, or have central nervous system involvement with RS/B-CLL

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 Baseline period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab will be infused intravenously on day 1 (300 mg), day 8 (1000 mg) and day 15 (1000mg) in the first cycle, followed by infusions every 3 weeks of 1000 mg on the first day of each cycle for a total of 6 cycles.

    Number of subjects in period 1 [1]
    		Baseline
    Started
    37
    Completed
    37
    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: 43 patients were enrolled in the trial, but only 37 patients were found to be evaluable, and hence the number in the baseline period is the number of evaluable patients.
    Period 2
    Period 2 title
    Induction
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ofatumumab + CHOP
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab will be infused intravenously on day 1 (300 mg), day 8 (1000 mg) and day 15 (1000mg) in the first cycle, followed by infusions every 3 weeks of 1000 mg on the first day of each cycle for a total of 6 cycles.

    Number of subjects in period 2
    		Ofatumumab + CHOP
    Started
    37
    Completed
    37
    Period 3
    Period 3 title
    Maintenance
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ofatumumab + CHOP
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab will be infused intravenously on day 1 (300 mg), day 8 (1000 mg) and day 15 (1000mg) in the first cycle, followed by infusions every 3 weeks of 1000 mg on the first day of each cycle for a total of 6 cycles.

    Number of subjects in period 3
    		Ofatumumab + CHOP
    Started
    37
    Completed
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 37 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 16 16
        85 years and over
    		 3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.3 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 26 26
    ECOG Performance Status
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Activity Performance Description
    Units: Subjects
        Score 0
    		 17 17
        Score 1
    		 12 12
        Score 2
    		 4 4
        Score 3
    		 4 4
    Ann Arbour Staging
    Ann Arbour Staging (DBCL criteria)
    Units: Subjects
        Not assessed/documented
    		 1 1
        Stage I
    		 6 6
        Stage II
    		 6 6
        Stage III
    		 15 15
        Stage IV
    		 9 9
    Rai Staging
    Units: Subjects
        Stage 0
    		 11 11
        Stage I
    		 11 11
        Stage II
    		 9 9
        Stage III
    		 3 3
        Stage IV
    		 2 2
        Not assessed/documented
    		 1 1
    Binet Staging
    Units: Subjects
        Clinical stage A
    		 19 19
        Clinical stage B
    		 12 12
        Clinical stage C
    		 6 6
    B-symptoms history
    History of constitutional symptoms (B-symptoms): o Experience of night sweats (without signs of infection) o Unexplained, unintentional weight loss > 10% within the previous 6 months o Experience of extreme fatigue o Recurrent, unexplained fever of greater than 38'C or 100.5'F for 2 weeks
    Units: Subjects
        Yes
    		 22 22
        No
    		 15 15
    Platelet Count
    Units: Subjects
        < 100 x 10^9/l
    		 10 10
        >100 x 10^9/l
    		 27 27
    Bulk in lymph node over 5 cm
    Units: Subjects
        Yes
    		 18 18
        No
    		 19 19
    Previous treatments
    Previous treatments of B-CLL
    Units: Subjects
        None
    		 17 17
        One
    		 12 12
        Two or more
    		 8 8
    Subject analysis sets

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All evaluable patients have baseline characteristics available.

    Subject analysis set title
    Evaluable patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients recruited who received at least one full cycle of CHOP-O and had a response assessment by either clinical examination or CT scan.

    Subject analysis sets values
    		 Baseline Evaluable patients
    Number of subjects
    37
    37
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    ECOG Performance Status
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Activity Performance Description
    Units: Subjects
        Score 0
    17
        Score 1
    12
        Score 2
    4
        Score 3
    4
    Ann Arbour Staging
    Ann Arbour Staging (DBCL criteria)
    Units: Subjects
        Not assessed/documented
    1
        Stage I
    6
        Stage II
    6
        Stage III
    15
        Stage IV
    9
    Rai Staging
    Units: Subjects
        Stage 0
    11
        Stage I
    11
        Stage II
    9
        Stage III
    3
        Stage IV
    2
        Not assessed/documented
    1
    Binet Staging
    Units: Subjects
        Clinical stage A
    19
        Clinical stage B
    12
        Clinical stage C
    6
    B-symptoms history
    History of constitutional symptoms (B-symptoms): o Experience of night sweats (without signs of infection) o Unexplained, unintentional weight loss > 10% within the previous 6 months o Experience of extreme fatigue o Recurrent, unexplained fever of greater than 38'C or 100.5'F for 2 weeks
    Units: Subjects
        Yes
    22
        No
    15
    Platelet Count
    Units: Subjects
        < 100 x 10^9/l
    10
        >100 x 10^9/l
    27
    Bulk in lymph node over 5 cm
    Units: Subjects
        Yes
    18
        No
    19
    Previous treatments
    Previous treatments of B-CLL
    Units: Subjects
        None
    17
        One
    12
        Two or more
    8

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline period
    Reporting group title
    Ofatumumab + CHOP
    Reporting group description
    		 -
    Reporting group title
    Ofatumumab + CHOP
    Reporting group description
    		 -

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All evaluable patients have baseline characteristics available.

    Subject analysis set title
    Evaluable patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients recruited who received at least one full cycle of CHOP-O and had a response assessment by either clinical examination or CT scan.

    Primary: Objective response rate

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    End point title
    		 Objective response rate [1]
    End point description
    The primary objective of the trial is to determine the objective response rate (ORR) of ofatumumab plus CHOP according to the Revised Response Criteria for Malignant Lymphoma (Cheson criteria) as measured after induction. Patients will be classified as responders/non-responders as follows: complete remission (CR), partial remission (PR) or nodular partial remission (nPR) as responders while stable disease (SD) and progressive disease (PD) as non-responders.
    End point type
    Primary
    End point timeframe
    After cycle 6, or if the patient withdraws from treatment earlier than cycle 6, their response recorded at withdrawal will be used. Or if an assessment is not performed at withdrawal, the latest disease response is used (i.e. post cycle 4)
    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: No formal comparison of the primary end point has been made as there is only one treatment arm.
    End point values
    		 Evaluable patients
    Number of subjects analysed
    37
    Units: Patients
        Responders
    17
        Non-responders
    20
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Length of survival is defined in months as the time from entry into the study until death from any cause. Those who are not observed to die during the course of the trial will be censored at their last known follow-up date.
    End point values
    		 Evaluable patients
    Number of subjects analysed
    37
    Units: Months
        median (confidence interval 95%)
    11.4 (6.4 to 25.6)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Length of survival is defined in months as the time from entry into the study until lymphoma progression or death from any cause. Those who are not observed to progress or die during the course of the trial will be censored at their last known progres
    End point values
    		 Evaluable patients
    Number of subjects analysed
    37
    Units: Months
        median (confidence interval 95%)
    6.2 (4.9 to 14)
    No statistical analyses for this end point

    Secondary: Constitutional symptoms (B-symptoms)

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    End point title
    		 Constitutional symptoms (B-symptoms)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline.
    End point values
    		 Evaluable patients
    Number of subjects analysed
    37
    Units: Patients
        Experience of night sweats
    15
        Unexplained weight loss >10% within last 6 months
    9
        Experience of extreme fatigue
    6
        Recurrent, unexplained fever >38 deg's for 2 weeks
    4
    No statistical analyses for this end point

    Secondary: ECOG Performance Status

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    End point title
    		 ECOG Performance Status
    End point description
    End point type
    Secondary
    End point timeframe
    Post cycle 6
    End point values
    		 Evaluable patients
    Number of subjects analysed
    37
    Units: Patients
        Zero
    10
        One
    6
        Two
    0
        Three
    0
        Not assessed/documented
    3
        Withdrew prior to assessment
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Event Monitoring starts from the time the patient gives informed consent, unless specified otherwise, and until they complete the trial.
    Adverse event reporting additional description
    Only AEs of CTCAE grade 3 or grade 4 are reported here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 All patients who received at least one dose of the trial treatment, including those deemed not evaluable for the primary outcome.

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 43 (83.72%)
         number of deaths (all causes)
    28
         number of deaths resulting from adverse events
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Soft tissue mass
    Additional description: Soft tissue paravertebral mass (necrotic tumour)
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma of colon
    Additional description: Adenocarcinoma - Sigmoid Colon
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Ischaemia
    Additional description: Ischaemia cerebrovascular
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    7 / 43 (16.28%)
         occurrences causally related to treatment / all
    8 / 9
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Unwell
    Additional description: Patient looked generally unwell
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    Disease progression
         subjects affected / exposed
    7 / 43 (16.28%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 7
    Infusion related reaction
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion site extravasation
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorder
    Additional description: Patient unwell overnight, D&V, stomach pains.
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonic perforation
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Endocarditis
    Additional description: Endocarditis infective
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    Neutropenic sepsis
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences causally related to treatment / all
    8 / 8
         deaths causally related to treatment / all
    0 / 1
    Skin infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 43 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
    Additional description: Adenocarcinoma of sigmoid colon unrelated to the trial treatment.
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Soft tissue mass
    Additional description: Soft tissue paravertebral mass (necrotic tumor)
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Fever
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    4
    Infusion related reaction
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    Malaise
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Other
    Additional description: Fever and diarrhoa - treated as neutropenic sepsis with antibiotics however was not septic.
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Aspiration
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Pleural effusion
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    10
    Platelet count decreased
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    9 / 43 (20.93%)
         occurrences all number
    14
    Non-Febrile Neutropenia
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Anal pain
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Colonic perforation
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Anorectal infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Endocarditis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    4
    Sepsis
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    7
    Skin infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Feb 2011
    Substantial Amendment 001: Addition of new sites – Kings College Hospital and UCLH
    30 Mar 2011
    Substantial Amendment 002: Addition of new site – Nottingham, Removal of existing site – Queen Elizabeth Hospital
    13 Jun 2011
    Substantial Amendment 003: PIS update
    17 Jun 2011
    Substantial Amendment 004: Addition of a new site – Queen Elizabeth Hospital, Birmingham
    26 Oct 2011
    Substantial Amendment 005: Addition of questionnaire booklets
    24 Apr 2012
    Substantial Amendment 006: Addition of a new site – Royal Marsden Hospital London
    09 Jul 2012
    Substantial Amendment 007: Change of drug distribution centre – from Aptuit to Catalent
    30 Apr 2013
    Substantial Amendment 008: PIS update
    02 Sep 2013
    Substantial Amendment 009: Protocol update: change to exclusion criteria, timing of assessments and SAE criteria.
    22 Jan 2014
    Substantial Amendment 010: Change of PI at Royal Bournemouth Hospital
    16 Jul 2014
    Substantial Amendment 011: PIS update
    31 Oct 2014
    Substantial Amendment 012: Protocol update: addition of list of adverse events, clarification of ‘objective response’, changes to contact information GP Letter update, IB update

    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.
    The data is not compared in a prospective randomized clinical trial. The small number of patients is one limitation, and unfortunately, only limited data of sufficient quality were available for a number of endpoints, meaning no formal analyses.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27378086
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