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    Clinical Trial Results:
    Freiburger Studie zur Behandlung von Primären ZNS-Lymphomen bei Patienten über 65 Jahre: Methotrexat-basierte Chemo-Immuntherapie mit anschließender Erhaltungstherapie - PRIMAIN-Studie -

    Summary
    EudraCT number
    		 2008-007645-31
    Trial protocol
    		 DE  
    Global end of trial date
    05 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2020
    First version publication date
    10 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    00591
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00989352
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trials Register: DRKS00000582
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Breisacher Str. 153, Freiburg, Germany, 79110
    Public contact
    Elvira Burger-Martin, Medical Center - University of Freiburg, +49 761 27073780, elvira.burger@uniklinik-freiburg.de
    Scientific contact
    Prof. Dr. Gerald Illerhaus, Klinikum Stuttgart, +49 711 27830456, g.illerhaus@klinikum-stuttgart.de
    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
    16 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary end point was the Complete remission rate measured after 3 cycles of R-MPL (rituximab, HD-MTX, procarbazine and lomustine). Secondary end points were toxicity, neurotoxicity as evaluated by the mini-mental status test (MMST), quality of life (QoL) using the European Organization for Research and Treatment of Cancer QoL core questionnaire (EORTC QLQ-C30 Version 3.0)10 and QLQ-BN20 for brain cancer, best response achieved during immuno-chemotherapy, PFS defined as time from the start of treatment until progression or death from any cause whichever occurred first and overall survival (OS) defined as time from the start of treatment until death from any cause.
    Protection of trial subjects
    The study conformed to the tenets of the Declaration of Helsinki and approved by the local ethics committee at Freiburg University and the ethics committees at participating centres.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2009
    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
    Germany: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    107
    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)
    0
    From 65 to 84 years
    106
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 107
    Number of subjects completed
    		 107

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

    Arms
    Arm title
    		 R-MPL / R-MP
    Arm description
    		 One cycle of R-MPL consisted of rituximab 375 mg/m2 infused in 90 min on day − 6 (only at the beginning of treatment), days 1, 15 and 29; HD-MTX 3 g/m2 over 4 h on days 2, 16 and 30; lomustine 110 mg/m2 orally on day 2, and procarbazine 60 mg/m2 orally on days 2–11. started. Cycles were repeated every 42 days with 3 cycles planned in total. Maintenance treatment with procarbazine 100 mg for 5 days (6 cycles repeated on day 29) was started on day 43 of the last R-MPL cycle. After protocol amendment, lomustine was omitted and all patients were treated with R-MP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m2 infused in 90 min on day − 6 (only at the beginning of treatment), days 1, 15 and 29.

    Investigational medicinal product name
    Highdose methotrexate (HD-MTX)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 g/m2 over 4 h on days 2, 16 and 30.

    Investigational medicinal product name
    Lomustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    110 mg/m2 orally on day 2.

    Investigational medicinal product name
    Procarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2 orally on days 2–11.

    Number of subjects in period 1
    		R-MPL / R-MP
    Started
    107
    Completed
    107

    Baseline characteristics

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

    Reporting group values
    		 Overall Total
    Number of subjects
    		 107 107
    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)
    		 0 0
        From 65-84 years
    		 106 106
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 73 (66 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 50 50
        Male
    		 57 57
    Subject analysis sets

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Five patients were excluded because of systemic lymphoma involvement at registration or having a diagnosis of relapsed PCNSL. Finally, 107 eligible patients were included in the ITT population.

    Subject analysis sets values
    		 Intention to treat
    Number of subjects
    107
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    106
        85 years and over
    1
    Age continuous
    Units: years
        median (full range (min-max))
    73 (66 to 85)
    Gender categorical
    Units: Subjects
        Female
    50
        Male
    57

    End points

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    End points reporting groups
    Reporting group title
    R-MPL / R-MP
    Reporting group description
    		 One cycle of R-MPL consisted of rituximab 375 mg/m2 infused in 90 min on day − 6 (only at the beginning of treatment), days 1, 15 and 29; HD-MTX 3 g/m2 over 4 h on days 2, 16 and 30; lomustine 110 mg/m2 orally on day 2, and procarbazine 60 mg/m2 orally on days 2–11. started. Cycles were repeated every 42 days with 3 cycles planned in total. Maintenance treatment with procarbazine 100 mg for 5 days (6 cycles repeated on day 29) was started on day 43 of the last R-MPL cycle. After protocol amendment, lomustine was omitted and all patients were treated with R-MP.

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Five patients were excluded because of systemic lymphoma involvement at registration or having a diagnosis of relapsed PCNSL. Finally, 107 eligible patients were included in the ITT population.

    Primary: Complete remission

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    End point title
    		 Complete remission [1]
    End point description
    End point type
    Primary
    End point timeframe
    after 3 cycles
    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: Single arm study. The primary end point was analysed by calculating the CR rate with the two-sided 95% confidence interval (CI) based on the binomial distribution. Based on 107 evaluable patients, the null hypothesis (CR probability was 0.4 at a significance level alpha = 10%) could be rejected if the number of observed CRs is ⩾50.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    38
    No statistical analyses for this end point

    Secondary: Partial remission

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    End point title
    		 Partial remission
    End point description
    End point type
    Secondary
    End point timeframe
    after 3 cycles
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    15
    No statistical analyses for this end point

    Secondary: Stable disease

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    End point title
    		 Stable disease
    End point description
    End point type
    Secondary
    End point timeframe
    after 3 cycles
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    0
    No statistical analyses for this end point

    Secondary: Progressive disease / relapse

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    End point title
    		 Progressive disease / relapse
    End point description
    End point type
    Secondary
    End point timeframe
    after 3 cycles
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    12
    No statistical analyses for this end point

    Secondary: Complete remission, best response achieved

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    End point title
    		 Complete remission, best response achieved
    End point description
    End point type
    Secondary
    End point timeframe
    Best response achieved during immuno-chemotherapy.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    45
    No statistical analyses for this end point

    Secondary: Partial remission, best response achieved

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    End point title
    		 Partial remission, best response achieved
    End point description
    End point type
    Secondary
    End point timeframe
    Best response achieved during immuno-chemotherapy.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    34
    No statistical analyses for this end point

    Secondary: Stable disease, best response achieved

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    End point title
    		 Stable disease, best response achieved
    End point description
    End point type
    Secondary
    End point timeframe
    Best response achieved during immuno-chemotherapy.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    1
    No statistical analyses for this end point

    Secondary: Progressive disease, best response achieved

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    End point title
    		 Progressive disease, best response achieved
    End point description
    End point type
    Secondary
    End point timeframe
    Best response achieved during immuno-chemotherapy.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    2
    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
    Time from the start of treatment until progression or death from any cause whichever occurred first.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Months
        median (confidence interval 95%)
    10.3 (6.5 to 15.9)
    No statistical analyses for this end point

    Secondary: Progression-free survival, 1-year rate %

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    End point title
    		 Progression-free survival, 1-year rate %
    End point description
    End point type
    Secondary
    End point timeframe
    Time from the start of treatment until progression or death from any cause whichever occurred first.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Rate (%)
        number (confidence interval 95%)
    46.3 (36.8 to 55.8)
    No statistical analyses for this end point

    Secondary: Progressive-free survival, 2-year rate %

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    End point title
    		 Progressive-free survival, 2-year rate %
    End point description
    End point type
    Secondary
    End point timeframe
    time from the start of treatment until progression or death from any cause whichever occurred first.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Rate (%)
        number (confidence interval 95%)
    37.3 (28.0 to 46.6)
    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
    Time from the start of treatment until death from any cause.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Months
        median (confidence interval 95%)
    20.7 (10.7 to 44.8)
    No statistical analyses for this end point

    Secondary: Overall survival, 1-year rate %

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    End point title
    		 Overall survival, 1-year rate %
    End point description
    End point type
    Secondary
    End point timeframe
    Time from the start of treatment until death from any cause.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Rates (%)
        number (confidence interval 95%)
    56.7 (47.2 to 66.1)
    No statistical analyses for this end point

    Secondary: Overall survival, 2-year rate %

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    End point title
    		 Overall survival, 2-year rate %
    End point description
    End point type
    Secondary
    End point timeframe
    Time from the start of treatment until death from any cause.
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Rates (%)
        number (confidence interval 95%)
    47.0 (37.3 to 56.7)
    No statistical analyses for this end point

    Secondary: Toxicity: Leukopenia

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    End point title
    		 Toxicity: Leukopenia
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    10
        Grade 2
    20
        Grade 3
    44
        Grade 4
    15
    No statistical analyses for this end point

    Secondary: Toxicity: Anaemia

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    End point title
    		 Toxicity: Anaemia
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    12
        Grade 2
    51
        Grade 3
    33
        Grade 4
    2
    No statistical analyses for this end point

    Secondary: Toxicity: Thrombocytopenia

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    End point title
    		 Toxicity: Thrombocytopenia
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    21
        Grade 2
    13
        Grade 3
    20
        Grade 4
    11
    No statistical analyses for this end point

    Secondary: Toxicity: Infections

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    End point title
    		 Toxicity: Infections
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    5
        Grade 2
    20
        Grade 3
    32
        Grade 4
    3
    No statistical analyses for this end point

    Secondary: Toxicity: Transaminases

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    End point title
    		 Toxicity: Transaminases
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    34
        Grade 2
    24
        Grade 3
    24
        Grade 4
    3
    No statistical analyses for this end point

    Secondary: Toxicitiy: Hyperbilirubinaemia

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    End point title
    		 Toxicitiy: Hyperbilirubinaemia
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    18
        Grade 2
    2
        Grade 3
    0
        Grade 4
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Renal impairment (serum creatinine)

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    End point title
    		 Toxicity: Renal impairment (serum creatinine)
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    31
        Grade 2
    21
        Grade 3
    6
        Grade 4
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Mucositis

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    End point title
    		 Toxicity: Mucositis
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
        Grade 1
    15
        Grade 2
    14
        Grade 3
    8
        Grade 4
    0
    No statistical analyses for this end point

    Secondary: Toxic deaths

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    End point title
    		 Toxic deaths
    End point description
    End point type
    Secondary
    End point timeframe
    during treatment
    End point values
    		 Intention to treat
    Number of subjects analysed
    107
    Units: Number of patients
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Complete study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    R-MPL
    Reporting group description
    		 Rituximab (375 mg/m², days 1, 15, 29), high-dose methotrexate (3 g/m² days 2, 16, 30), procarbazine (60 mg/m² days 2-11) and lomustine (110 mg/m², day 2)

    Reporting group title
    R-MP
    Reporting group description
    		 Rituximab (375 mg/m², days 1, 15, 29), high-dose methotrexate (3 g/m² days 2, 16, 30), procarbazine (60 mg/m² days 2-11)

    Serious adverse events
    		 R-MPL R-MP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    41 / 69 (59.42%)
    26 / 38 (68.42%)
         number of deaths (all causes)
    41
    18
         number of deaths resulting from adverse events
    10
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Progression einer Neubildung
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Fieber
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generelle Verschlechterung des physischen Gesundheitszustandes
         subjects affected / exposed
    3 / 69 (4.35%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Schleimhautentzuendung
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Versagen mehrerer Organe
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lungenembolie
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Orientierungsstoerung
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wahn
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alaninaminotransferase anomal
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allgemeinzustand nach der Eastern Cooperative Oncology Group verschlechtert
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin erniedrigt
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kreatinin im Blut erhoeht
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nierenfunktionstest anomal
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminasen erhoeht
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fraktur eines Lendenwirbels
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frakturen von Gesichtsknochen
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sturz
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdurales Haematom
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myokardinfarkt
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perikarderguss
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    akuter Myokardinfarkt
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    akutes Koronarsyndrom
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hirnoedem
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hirnstammischaemie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Koma
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Konvulsion
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparese
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transitorische ischaemische Attacke
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    zerebrale Thrombose
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (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 Neutropenie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Analblutung
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoe
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dickdarmperforation
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erbrechen
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Magengeschwuer
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss Syndrom
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uebelkeit
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    akutes Abdomen
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    erosive Duodenitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageale Refluxerkrankung
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Arzneimittelbedingter Leberschaden
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ausschlag
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ausschlag generalisiert
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nierenfunktionsbeeintraechtigung
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nierenversagen
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nierenversagen akut
         subjects affected / exposed
    3 / 69 (4.35%)
    4 / 38 (10.53%)
         occurrences causally related to treatment / all
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bakterielle Harnwegsinfektion
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bakterielle Sepsis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Bronchopneumonie
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candidose des Oesophagus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile-Infektion
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus hepatitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Divertikulitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterokokken-Bakteriaemie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis durch Norovirus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Geraetebedingte Sepsis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Harnwegsinfektion
         subjects affected / exposed
    0 / 69 (0.00%)
    3 / 38 (7.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infektion
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infektion an der Katheterstelle
         subjects affected / exposed
    1 / 69 (1.45%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infektion im Zusammenhang mit einem medizinischen Geraet
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella-Sepsis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsielleninfektion
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii-Pneumonie
         subjects affected / exposed
    3 / 69 (4.35%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonie
         subjects affected / exposed
    8 / 69 (11.59%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    3 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonie durch Klebsiella
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 69 (7.25%)
    3 / 38 (7.89%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 3
         deaths causally related to treatment / all
    2 / 2
    0 / 2
    Sepsis durch Staphylokokken
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septischer Schock
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wundinfektion
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Zystitits escherichia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atypische Pneumonie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile Infektion
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    orale Candidose
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonale Sepsis
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Metabolism and nutrition disorders
    Dehydratation
         subjects affected / exposed
    3 / 69 (4.35%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 R-MPL R-MP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 69 (28.99%)
    13 / 38 (34.21%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    zerebrales Hygrom
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotonie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Venenthrombose einer Extremitaet
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Arzneimittelunvertraeglichkeit
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Fieber
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    grippeaehnliche Erkrankung
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Schlaflosigkeit
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Leukozytenzahl erniedrigt
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Transaminasen erhoeht
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Schilddruesenunterfunktion nach einem Eingriff
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Sturz
         subjects affected / exposed
    3 / 69 (4.35%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Ataxie
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    periphere sensorische Neuropathie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukopenie
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Neutropenie
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Hoersturz
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Eye disorders
    Papillenoedem
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    ischaemische Neuropathie des Nervus opticus
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoe
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Enterokolitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Uebelkeit
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Arzneimittelwirkung mit Eosinophilie und systemischen Symptomen
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Ausschlag
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Ekzem asteatotisch
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Medikamentenausschlag
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Harnverhaltung
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Androgenmangel
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Diabetes insipidus
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Infections and infestations
    Bakteraemie
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis durch Clostridien
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis durch Norovirus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Harnwegsinfektion
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Infektion der oberen Atemwege
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Pneumonie durch Herpes simplex
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Zystitits escherichia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    ophthalmischer Herpes zoster
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    oraler Herpes
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Hyponatriaemie
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2012
    1. Increase of sample size; 2. Dropping Lomustine from the therapy protocol due to several reported adverse and serious adverse events associated with treatment (mainly haematological toxicities and infections).

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/2784313
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