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    Clinical Trial Results:
    Immunochemotherapy in Primary Central Nervous System Lymphoma with Rituximab, HD-MTX, HD-Ara C, cyclophosphamide, ifosfamide, vincristine, vindesine, temozolomide and DepoCyte induction followed by maintenance treatment in elderly patients with temozolomide.

    Summary
    EudraCT number
    		 2006-004772-12
    Trial protocol
    		 DK   SE   FI  
    Global end of trial date
    13 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2023
    First version publication date
    11 Oct 2023
    Other versions
    Summary report(s)
    		 Adverse Events

    Trial information

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    Trial identification
    Sponsor protocol code
    NLGPCNSL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01458730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nordic Lymphoma Group
    Sponsor organisation address
    Tage Hansens Gade 2, Aarhus, Denmark, 8000
    Public contact
    Elisa Pulczynski, Elisa Pulczynski, e.jacobsen@dadlnet.dk
    Scientific contact
    Elisa Pulczynski, Elisa Pulczynski, e.jacobsen@dadlnet.dk
    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
    06 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma 2. To assess the long term outcome concerning neurotoxicity
    Protection of trial subjects
    The study was monitored by the Good Clinical Practice Unit at Aarhus and Aalborg University Hospitals. And the study was conducted according to the Helsinki declaration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2007
    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
    Norway: 24
    Country: Number of subjects enrolled
    Sweden: 27
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    Finland: 7
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    39
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited in clinic and the in- and exclusion criteria checked.

    Pre-assignment
    Screening details
    		 The patients were screened for in- and exclusion criteria.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 18-65 years
    Arm description
    		 Patients in the age group 18-65 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methotrexat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 18-65 years will receive HD-MTX 5g/ m2 four cycles administered intravenously over three hours on weeks 1, 4, 10 and 13.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 18-65 years received Cytarabine 1.5g/m2 two cycles administered intravenously over three hours every 12 hours for two days on weeks 7 and 16.

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 18-65 years received ifosfamide 800 mg/m2 intravenously two cycles administered for four days during the weeks 1 and 10.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 18-65 years received cyclophosphamide 200 mg/m2 intravenously two cycles administered for four days during the weeks 4 and 13.

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    Patients aged 18-65 years received vincristine 2 mg intravenously administered once on week 4 and once on week 13

    Investigational medicinal product name
    Vindesine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    All patients received vindesine 5 mg intravenously administered once on week 7 and once on week 16

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients received dexamethasone orally 10 mg/m2 for four days during the weeks 1, 4, 10 and 13 and 20 mg/m2 for five days during the weeks 7 and 16

    Investigational medicinal product name
    DepoCyte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    All patients received DepoCyte 50 mg four treatments administered intraspinally on weeks 1, 4, 10 and 13

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab (375mg/m2) was administered intravenously prior to the first HD-MTX infusion in case of CD20 + lymphoma

    Arm title
    		 66-75 years
    Arm description
    		 Patients in the age group 66-75 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methotrexat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 66-75 years will receive HD-MTX 3g/m2 four cycles administered intravenously over three hours on weeks 1, 4, 10 and 13.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 66-75 years received Cytarabine 1g/m2 two cycles administered intravenously over three hours every 12 hours for two days on weeks 7 and 16.

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients aged 66-75 years received ifosfamide 800mg/m2 intravenously one cycle administered for four days during week 1.

    Investigational medicinal product name
    Vindesine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    All patients received vindesine 5 mg intravenously administered once on week 7 and once on week 16

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients aged 66-75 years received temozolomide 150mg/m2 orally for five days during the weeks 4, 10 and 13 and thereafter once a month for one year.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients received dexamethasone orally 10 mg/m2 for four days during the weeks 1, 4, 10 and 13 and 20 mg/m2 for five days during the weeks 7 and 16

    Investigational medicinal product name
    DepoCyte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    All patients received DepoCyte 50 mg four treatments administered intraspinally on weeks 1, 4, 10 and 13

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Rituximab (375mg/m2) was administered intravenously prior to the first HD-MTX infusion in case of CD20 + lymphoma

    Number of subjects in period 1
    		18-65 years 66-75 years
    Started
    39
    27
    Completed
    38
    24
    Not completed
    1
    3
         Treatment related deaths
    -
    3
         Treament related deaths
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18-65 years
    Reporting group description
    		 Patients in the age group 18-65 years

    Reporting group title
    66-75 years
    Reporting group description
    		 Patients in the age group 66-75 years

    Reporting group values
    		 18-65 years 66-75 years Total
    Number of subjects
    		 39 27 66
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 39 0 39
        From 65-84 years
    		 0 27 27
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 16 15 31
        Male
    		 23 12 35

    End points

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    End points reporting groups
    Reporting group title
    18-65 years
    Reporting group description
    		 Patients in the age group 18-65 years

    Reporting group title
    66-75 years
    Reporting group description
    		 Patients in the age group 66-75 years

    Primary: Overall survival - complete treatment and follow-up course

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    End point title
    		 Overall survival - complete treatment and follow-up course [1]
    End point description
    End point type
    Primary
    End point timeframe
    10 years after completed therapy.
    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: See article, linked under "More information"
    End point values
    		 18-65 years 66-75 years
    Number of subjects analysed
    39
    27
    Units: percent
        number (not applicable)
    14.1
    22.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events was observed at treatment sites
    Adverse event reporting additional description
    There are 6 treatment cycles in the study. They are called: A1 – B1 – C1 – A2 – B2 and C2. The toxicity (both haematological and infection-related) differs according to the different treatment cycles.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Adverse Events were not possible to report in the schemes, therefore reported in document, uploaded in the index

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2006
    Adding GCSF

    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/25480497
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