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    Clinical Trial Results:
    A Randomised Study to Investigate the Efficacy of Bendamustine in Subjects with Indolent Non-Hodgkin’s Lymphoma (NHL) Refractory to Rituximab

    Summary
    EudraCT number
    		 2010-022102-41
    Trial protocol
    		 SK   ES   IT   PT   PL  
    Global end of trial date
    31 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2019
    First version publication date
    07 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BDM3502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mundipharma Research Ltd.
    Sponsor organisation address
    194-198 Cambridge Science Park, Cambridge, United Kingdom, CB4 0AB
    Public contact
    Clinical Operations, Mundipharma Research Ltd., +44 1223 424900, info@contact-clinical-trials.com
    Scientific contact
    Clinical Operations, Mundipharma Research Ltd., +44 1223 424900, info@contact-clinical-trials.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
    31 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to compare the efficacy of bendamustine against treatment of physician’s choice (TPC) on progression free survival (PFS) in subjects with indolent B-cell in Non-Hodgkin’s Lymphoma (NHL) that did not respond (stable disease [SD] or progressive disease [PD]) to rituximab or a rituximab containing regimen during or within 6 months of the previous rituximab treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 Medications to treat nausea and vomiting or acquired infections during the study were allowed. Blood products and growth factors were allowed at the discretion of the Investigator.
    Evidence for comparator
    		 Treatment in the reference arm was Treatment of Physician’s Choice (TPC) which was defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was experimental in nature. The use of bendamustine was not permitted during the Treatment Phase.
    Actual start date of recruitment
    04 Nov 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
    Poland: 3
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Australia: 91
    Worldwide total number of subjects
    109
    EEA total number of subjects
    18
    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)
    48
    From 65 to 84 years
    59
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 25 centers in 5 countries.

    Pre-assignment
    Screening details
    		 A total of 109 subjects were enrolled into this study, of which 21 subjects were screen failures (21 due to Non-compliance; 1 due to Subject's choice and 2 due to Other reason). Out of the 88 subjects randomised, 54 subjects completed and 31 subjects discontinued the study due to Adverse Events (21), Administrative (1) and Disease Progression (9).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bendamustine
    Arm description
    		 Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenously bendamustine 120 mg/m^2

    Arm title
    		 Treatment of Physician’s Choice (TPC)
    Arm description
    		 Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase.
    Arm type
    		 TPC

    Investigational medicinal product name
    Multiple cancer specific therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Variable treatment was given according to the label and based upon local institutional medical practice and clinical judgement.

    Number of subjects in period 1 [1]
    		Bendamustine Treatment of Physician’s Choice (TPC)
    Started
    58
    30
    Completed
    39
    15
    Not completed
    19
    15
         Never Treated
    -
    3
         Administrative
    1
    -
         Adverse event, non-fatal
    14
    7
         Disease Progression
    4
    5
    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: A total of 109 subjects were enrolled into this study, of which 21 subjects were screen failures and only 88 subjects randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bendamustine
    Reporting group description
    		 Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered.

    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase.

    Reporting group values
    		 Bendamustine Treatment of Physician’s Choice (TPC) Total
    Number of subjects
    		 58 30 88
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.8 ( 11.75 ) 65.4 ( 9.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 18 42
        Male
    		 34 12 46

    End points

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    End points reporting groups
    Reporting group title
    Bendamustine
    Reporting group description
    		 Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered.

    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as time from randomization until disease progression or death due to any cause. For subjects who did not have an event (that is those who were lost to follow-up or who had not progressed at the date of data cut-off), PFS was censored. That is: PFS (days) = Date of progression/death/censoring – Date of randomization + 1. Subjects who did not progress in their disease were censored on the date of their last confirmed assessment. The Intent-to treat (ITT) population included all the subjects who were randomized irrespective of whether or not they actually received medication.
    End point type
    Primary
    End point timeframe
    From Day 1 up to end of the study (Approximately up to 7.5 years); Follow up was done every 6 months and 3 months for subjects with and without disease progression respectively.
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: months
        median (confidence interval 95%)
    18.5 (10.2 to 27.2)
    11.2 (7.1 to 18.7)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Bendamustine v Treatment of Physician’s Choice (TPC)
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.297
    Method
    		 Log-Rank test
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.752
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.403
         upper limit
    		 1.403

    Secondary: Percentage of Subjects with Overall Response Rate (ORR)

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    End point title
    		 Percentage of Subjects with Overall Response Rate (ORR)
    End point description
    ORR is defined as Percentage of subjects who confirmed Complete Remission (CR) or Partial Remission (PR) called as responders. Non-responders included subjects with stable disease (SD) or progressive disease (PD). CR is defined as complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy; all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (less than or equal to [<=] 1.5 centimeter [cm] in their greatest transverse diameter for nodes greater than [>] 1.5 cm before therapy). PR is defined as least a 50% decrease in the sum of product of the diameters (SPD) of up to six of largest dominant nodes or nodal masses. A subject was considered to have SD when he or she failed to attain the criteria needed for a CR or PR, but did not fulfill those for PD. The ITT population comprised of all subjects who were randomised irrespective of whether or not they actually received medication.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of the study (Approximately up to 7.5 years)
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: Percentage of subjects
    number (not applicable)
        ORR
    77.6
    56.7
        CR
    25.9
    10.0
        PR
    51.7
    46.7
        SD
    12.1
    20.0
        PD
    1.7
    13.3
    No statistical analyses for this end point

    Secondary: Duration of Response (DR)

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    End point title
    		 Duration of Response (DR)
    End point description
    DR is defined as time from initial response (CR/PR) to progression or death. Where CR is defined as complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy; all lymph nodes and nodal masses must have regressed on CT to normal size (<= 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). PR is defined as least a 50% decrease in the sum of product of the diameters of up to six of largest dominant nodes or nodal masses. A subject was considered to have SD when he or she failed to attain the criteria needed for a CR or PR, but did not fulfill those for PD. The ITT population comprised of all subjects who were randomised irrespective of whether or not they actually received medication. Here '99999' signifies not estimable as upper bound not reached.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of the study (Approximately up to 7.5 years)
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: months
        median (confidence interval 95%)
    17.5 (8.0 to 21.2)
    10.2 (5.0 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as time from randomization to death. The ITT population comprised of all subjects who were randomized irrespective of whether or not they actually received medication. Here '99999' in median signifies not estimable median survival time cannot be estimated because this group did not reached at the analysis cut off (survival was greater than 50% in the TPC group at the time of the last analysis), while '99999' in upper bound signifies not estimable as upper bound not reached.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of the study (Approximately up to 7.5 years)
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: months
        median (confidence interval 95%)
    38.4 (23.3 to 99999)
    99999 (19.6 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events

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    End point title
    		 Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, including placebo, and which did not necessarily have to have had a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. TEAEs are defined as new or worsening adverse events with an onset date occurring on or after first dose date of study medication inclusive to 30 days post-last dose. The Safety Population included all subjects who were randomized and who received at least 1 dose of study treatment. Here, 'Number of subjects analysed' signifies the subjects evaluable for this population.
    End point type
    Secondary
    End point timeframe
    From Day 1 of treatment administration up to 30 days after last treatment
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    27
    Units: Subjects
        TEAE
    58
    27
        TEAE of CTC grade 3 or 4
    44
    18
        Serious TEAE
    27
    7
        TEAE Leading to Death
    1
    0
        TEAE Leading to Discontinuation of study drug
    13
    3
        TEAE Leading to Dose Reduction
    20
    6
        TEAE Leading to Dose Withheld
    32
    10
    No statistical analyses for this end point

    Secondary: Change from Baseline in Health Related Quality of Life (HRQL) as Assessed by EuroQol Group (EQ-5D)

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    End point title
    		 Change from Baseline in Health Related Quality of Life (HRQL) as Assessed by EuroQol Group (EQ-5D)
    End point description
    EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a visual analog scale (VAS). Each dimension has 3 levels: No problems, Some problems, Severe problems. Responses to the single dimensions will be coded numerically 1 to 3 in order of decreasing health status. Responses to the EQ-5D will be converted into an EQ-5D index, which provides a single summary by weighting the response levels in each dimension . The weighted index constitutes a measure of utility and represents a health state from 0 to 1, where 1 is fullest health. This index will be derived only from patients who have provided a complete 5- response profile. The EQ VAS records the subject’s self–rated health where the endpoints are worst imaginable health (score=0) to best imaginable health (score =100). Here 'n' signifies number of subjects analysed for category at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 63 and Day 126
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: Units on a scale
    least squares mean (standard error)
        Day 63: EQ-5D Index (n=44, 17)
    0.748 ( 0.0358 )
    0.761 ( 0.0552 )
        Day 126: EQ-5D Index (n=29, 9)
    0.738 ( 0.0305 )
    0.847 ( 0.0511 )
        Day 63: EQ-5D VAS (n= 44, 17)
    62.5 ( 2.91 )
    58.5 ( 4.50 )
        Day 126: EQ-5D VAS (n=28, 9)
    60.9 ( 3.81 )
    63.2 ( 6.22 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Health Related Quality of Life as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Version 3.0

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    End point title
    		 Change from Baseline in Health Related Quality of Life as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Version 3.0
    End point description
    EORTC QLQ-C30 v3 is composed of 2 multi-item scales and single-item measures,: 1) Global scale: health status/quality of life (QoL) 2) Functional scales: physical/role/emotional/cognitive/social; 3) Symptom scales: fatigue/nausea/vomiting/pain/dyspnoea/insomnia/appetite loss/constipation/diarrhoea/financial impact. Global health status/ QoL questions are rated from very poor - excellent on scale of 1-7. All other questions are rated as not at all/a little/quite a bit/very much, coded from 1-4 in decreasing order health status. Each multi-item scales includes a different set of items - with no item repetition. All scales are transformed to have scores ranging from 0-100. High score for functional scale represents high/healthy functioning level, high score for global health status /QoL represents high QoL but high score for a symptom scale/item represents a high level of symptomatology/ problem. Here 'n' signifies number of subjects analysed for category at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 63 and Day 126
    End point values
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Number of subjects analysed
    58
    30
    Units: Units on a scale
    least squares mean (standard error)
        Day 63: Global health status/QoL (n= 44, 17)
    56.73 ( 3.569 )
    58.69 ( 5.610 )
        Day 126: Global health status/QoL (n= 29, 9)
    55.68 ( 3.894 )
    64.31 ( 6.558 )
        Day 63: Physical functioning (n= 45, 17)
    67.13 ( 3.427 )
    70.14 ( 5.401 )
        Day 126: Physical functioning (n= 30, 9)
    68.1 ( 3.449 )
    83.58 ( 5.866 )
        Day 63: Role functioning (n= 45, 17)
    59.55 ( 4.875 )
    62.26 ( 7.683 )
        Day 126: Role functioning (n= 30, 9)
    55.73 ( 5.461 )
    77.24 ( 9.268 )
        Day 63: Emotional functioning (n= 45, 17)
    75.42 ( 2.715 )
    78.06 ( 4.285 )
        Day 126: Emotional functioning (n= 30, 9)
    80.80 ( 3.340 )
    77.01 ( 5.690 )
        Day 63: Cognitive functioning (n= 45, 17)
    74.03 ( 3.501 )
    78.53 ( 5.518 )
        Day 126: Cognitive functioning (n= 30, 9)
    77.77 ( 4.112 )
    85.58 ( 7.023 )
        Day 63: Social functioning (n= 44, 17)
    61.90 ( 4.787 )
    63.61 ( 7.773 )
        Day 126: Social functioning (n= 30, 9)
    66.28 ( 5.108 )
    79.83 ( 9.291 )
        Day 63: Fatigue (n= 45, 17)
    51.09 ( 4.294 )
    39.86 ( 6.770 )
        Day 126: Fatigue (n= 30, 9)
    50.61 ( 4.389 )
    26.09 ( 7.487 )
        Day 63: Nausea and vomiting (n= 45, 17)
    17.61 ( 2.471 )
    10.92 ( 3.893 )
        Day 126: Nausea and vomiting (n= 30, 9)
    8.63 ( 3.005 )
    5.13 ( 5.094 )
        Day 63: Pain (n= 45, 17)
    21.89 ( 3.834 )
    25.24 ( 6.087 )
        Day 126: Pain (n= 30, 9)
    14.06 ( 4.322 )
    15.4 ( 7.429 )
        Day 63: Dyspnoea (n= 45, 17)
    22.01 ( 3.676 )
    14.09 ( 5.816 )
        Day 126: Dyspnoea (n= 30, 9)
    25.68 ( 4.689 )
    7.79 ( 7.991 )
        Day 63: Insomnia (n= 45, 17)
    33.51 ( 3.996 )
    41.10 ( 6.299 )
        Day 126: Insomnia (n= 30, 9)
    38.49 ( 6.813 )
    26.63 ( 11.571 )
        Day 63: Appetite loss (n= 45, 17)
    30.51 ( 4.398 )
    27.36 ( 6.936 )
        Day 126: Appetite loss (n= 30, 9)
    27.51 ( 5.24 )
    11.59 ( 9.057 )
        Day 63: Constipation (n= 45, 17)
    29.58 ( 3.671 )
    20.67 ( 5.797 )
        Day 126: Constipation (n= 30, 9)
    11.12 ( 3.523 )
    7.04 ( 5.971 )
        Day 63: Diarrhoea (n= 45, 17)
    17.75 ( 3.680 )
    7.20 ( 5.791 )
        Day 126: Diarrhoea (n= 30, 9)
    12.6 ( 3.893 )
    8.24 ( 6.591 )
        Day 63: Financial difficulties (n= 44, 17)
    21.21 ( 3.173 )
    23.59 ( 4.988 )
        Day 126: Financial difficulties (n= 30, 9)
    18.89 ( 4.068 )
    32.07 ( 6.867 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 of treatment administration up to 30 days after last treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Bendamustine
    Reporting group description
    		 Subjects received intravenously (IV) bendamustine 120 milligram per meter square (mg/m^2) on Days 1 and 2, every 21 days up to 6 cycles. However, if a subject was receiving clinical benefit after 6 cycles then a further 2 cycles of bendamustine were administered.

    Reporting group title
    Treatment of Physician’s Choice (TPC)
    Reporting group description
    		 Subjects received treatment of physician’s choice which is defined as any cancer specific therapy, or best supportive care. Treatment was given according to the label and based upon local institutional medical practice and clinical judgement. Treatment was not experimental in nature. Bendamustine treatment was not permitted as TPC in the treatment phase.

    Serious adverse events
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 58 (46.55%)
    7 / 27 (25.93%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 58 (17.24%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    7 / 11
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    5 / 58 (8.62%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bendamustine Treatment of Physician’s Choice (TPC)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 58 (100.00%)
    27 / 27 (100.00%)
    Investigations
    Platelet count decreased
         subjects affected / exposed
    10 / 58 (17.24%)
    3 / 27 (11.11%)
         occurrences all number
    23
    7
    Neutrophil count decreased
         subjects affected / exposed
    11 / 58 (18.97%)
    1 / 27 (3.70%)
         occurrences all number
    34
    1
    Weight decreased
         subjects affected / exposed
    6 / 58 (10.34%)
    1 / 27 (3.70%)
         occurrences all number
    8
    1
    White blood cell count decreased
         subjects affected / exposed
    5 / 58 (8.62%)
    2 / 27 (7.41%)
         occurrences all number
    13
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 58 (12.07%)
    2 / 27 (7.41%)
         occurrences all number
    8
    3
    Dysgeusia
         subjects affected / exposed
    6 / 58 (10.34%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    Lethargy
         subjects affected / exposed
    4 / 58 (6.90%)
    3 / 27 (11.11%)
         occurrences all number
    5
    3
    Neuropathy peripheral
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    Dizziness
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences all number
    5
    0
    Presyncope
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    27 / 58 (46.55%)
    8 / 27 (29.63%)
         occurrences all number
    40
    10
    Pyrexia
         subjects affected / exposed
    5 / 58 (8.62%)
    2 / 27 (7.41%)
         occurrences all number
    15
    2
    Oedema peripheral
         subjects affected / exposed
    8 / 58 (13.79%)
    1 / 27 (3.70%)
         occurrences all number
    9
    2
    Asthenia
         subjects affected / exposed
    7 / 58 (12.07%)
    0 / 27 (0.00%)
         occurrences all number
    10
    0
    Chills
         subjects affected / exposed
    5 / 58 (8.62%)
    0 / 27 (0.00%)
         occurrences all number
    7
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    19 / 58 (32.76%)
    8 / 27 (29.63%)
         occurrences all number
    45
    13
    Anaemia
         subjects affected / exposed
    13 / 58 (22.41%)
    5 / 27 (18.52%)
         occurrences all number
    31
    12
    Thrombocytopenia
         subjects affected / exposed
    13 / 58 (22.41%)
    4 / 27 (14.81%)
         occurrences all number
    36
    6
    Leukopenia
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    33 / 58 (56.90%)
    9 / 27 (33.33%)
         occurrences all number
    50
    9
    Constipation
         subjects affected / exposed
    27 / 58 (46.55%)
    4 / 27 (14.81%)
         occurrences all number
    31
    4
    Diarrhoea
         subjects affected / exposed
    18 / 58 (31.03%)
    5 / 27 (18.52%)
         occurrences all number
    29
    7
    Vomiting
         subjects affected / exposed
    14 / 58 (24.14%)
    5 / 27 (18.52%)
         occurrences all number
    22
    5
    Mouth ulceration
         subjects affected / exposed
    9 / 58 (15.52%)
    1 / 27 (3.70%)
         occurrences all number
    10
    1
    Abdominal pain
         subjects affected / exposed
    4 / 58 (6.90%)
    2 / 27 (7.41%)
         occurrences all number
    5
    2
    Dry mouth
         subjects affected / exposed
    5 / 58 (8.62%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 58 (10.34%)
    0 / 27 (0.00%)
         occurrences all number
    6
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Stomatitis
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 27 (7.41%)
         occurrences all number
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 58 (20.69%)
    5 / 27 (18.52%)
         occurrences all number
    15
    7
    Dyspnoea
         subjects affected / exposed
    7 / 58 (12.07%)
    0 / 27 (0.00%)
         occurrences all number
    8
    0
    Rhinitis allergic
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 58 (12.07%)
    2 / 27 (7.41%)
         occurrences all number
    8
    2
    Dry skin
         subjects affected / exposed
    5 / 58 (8.62%)
    1 / 27 (3.70%)
         occurrences all number
    5
    1
    Pruritus
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 58 (8.62%)
    2 / 27 (7.41%)
         occurrences all number
    5
    2
    Anxiety
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 27 (3.70%)
         occurrences all number
    4
    1
    Depression
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    7 / 58 (12.07%)
    1 / 27 (3.70%)
         occurrences all number
    7
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    8 / 58 (13.79%)
    0 / 27 (0.00%)
         occurrences all number
    8
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 27 (7.41%)
         occurrences all number
    3
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 58 (24.14%)
    3 / 27 (11.11%)
         occurrences all number
    16
    3
    Hypokalaemia
         subjects affected / exposed
    8 / 58 (13.79%)
    2 / 27 (7.41%)
         occurrences all number
    12
    2
    Hypomagnesaemia
         subjects affected / exposed
    6 / 58 (10.34%)
    1 / 27 (3.70%)
         occurrences all number
    7
    1
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 27 (0.00%)
         occurrences all number
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2011
    The overall reason of this amendment was to update study design methodology.

    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 study did not achieve the recruitment goal and was therefore terminated early.
    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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