Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Freiburger ZNS-NHL Studie: Therapie für Patienten mit primären Non-Hodgkin Lymphomen des ZNS – Sequentielle Hochdosis-Chemotherapie mit autologer peripherer Blutstammzelltransplantation. Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation.

    Summary
    EudraCT number
    		 2005-000615-99
    Trial protocol
    		 DE  
    Global end of trial date
    02 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    00465
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00647049
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trials Register: DRKS00003748
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Breisacher Str. 153, Freiburg, Germany, 79110
    Public contact
    Elvira Burger, Medical Center - University of Freiburg, Clinical Trials Unit, +49 761 270 73780, elvira.burger@uniklinik-freiburg.de
    Scientific contact
    Prof. Dr. med. Gerald Illerhaus (g.illerhaus@klinikum-stuttgart.de), Prof. Dr. med. Jürgen Finke, Medical Center - University of Freiburg, Center for Medicine, Department of Medicine I, +49 761 270 33640, juergen.finke@uniklinik-freiburg.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
    27 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of the efficacy of therapy with respect to the complete response rate 30 days after completion of the blood stem-cell transplantation. The study comprised two separate cohorts: 1. Newly diagnosed PCNSL15 and 2. Relapsed or refractory PCNSL. Here the results of the newly diagnosed cohort are reported. The results of the relapsed or refractory cohort are reported here: Kasenda B, Ihorst G, Schroers R, Korfel A, Schmidt-Wolf I, Egerer G, von Baumgarten L, Röth A, Bloehdorn J, Möhle R, Binder M, Keller U, Lamprecht M, Pfreundschuh M, Valk E, Fricker H, Schorb E, Fritsch K, Finke J, Illerhaus G. High-dose chemotherapy with autologous haematopoietic stem cell support for relapsed or refractory primary CNS lymphoma: a prospective multicentre trial by the German Cooperative PCNSL study group. Leukemia. 2017 Dec;31(12):2623-2629. doi: 10.1038/leu.2017.170. Epub 2017 May 31. PMID: 28559537.
    Protection of trial subjects
    The study conformed to the Declaration of Helsinki. The local ethics committee at Freiburg University and the ethics committees at all participating centres approved the study protocol and all amendments.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 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
    Germany: 79
    Worldwide total number of subjects
    79
    EEA total number of subjects
    79
    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)
    78
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 79
    Number of subjects completed
    		 79

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm study

    Arms
    Arm title
    		 Newly diagnosed primary CNS
    Arm description
    		 First diagnosis of PCNSL: combined chemotherapy with methotrexate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m²: Sequential induction treatment: five courses: 7 days before first high-dose methotrexate course and days 0, 10, 20, and 30 Therapy continuation with AraC/TT (14 days after last treatment with MTX): at day 0 (first cycle) and day 21 (second cycle) Therapy continuation with HD-BCNU/TT (21 days after last treatment with Arac/TT; day 43): at day 7 (first cycle) and day 21 (second cycle)

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four courses of high-dose methotrexate 8000 mg/m² on days 1, 11, 21, and 31 with folinic acid rescue

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Rescue

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Ara-C
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 g/m², days 2 and 3

    Investigational medicinal product name
    Thiotepa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Within first cycle of R-AraC/TT therapy: 40 mg/m² on day 2 Within second cycle of R-AraC/TT therapy: 40 mg/m² on day 23 At day 4 and 5 of therapy continuation: 2x5 mg/kg/die

    Investigational medicinal product name
    Carmustine
    Investigational medicinal product code
    Other name
    BCNU
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² at day 6 of therapy continuation (day 43)

    Investigational medicinal product name
    Granulocyte Colony Stimulating Factor (G-CSF)
    Investigational medicinal product code
    Other name
    Neupogen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Within first cycle of R-AraC/TT: from day 5 on: 5μg/kgKG (>70kg: 480μg, <70kg: 300μg) Within secondy cycle of R-AraC/TT: from day 26 on: G-CSF (Neupogen®) 1x/die s.c. bis WBC > 1000/μl 5μg/kgKG (>70kg: 480μg, <70kg: 300μg)

    Investigational medicinal product name
    Pegfilgrastim
    Investigational medicinal product code
    Other name
    Neulasta
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 mg. s.c. at day 4 of therapy continuation

    Number of subjects in period 1
    		Newly diagnosed primary CNS
    Started
    79
    Completed
    79

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 79 79
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 78 78
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 56 (51 to 62) -
    Gender categorical
    Units: Subjects
        Female
    		 35 35
        Male
    		 44 44

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Newly diagnosed primary CNS
    Reporting group description
    		 First diagnosis of PCNSL: combined chemotherapy with methotrexate

    Primary: Complete response

    		 Close Top of page
    End point title
    		 Complete response [1]
    End point description
    Proportion of patients with complete response: 77.2%; 95% CI: 66.1-86.6
    End point type
    Primary
    End point timeframe
    Best response 30 days after completion of HCT-ASCT
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single-arm study, i. e. no group comparison possible.
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    61
    No statistical analyses for this end point

    Secondary: Complete response achieved during induction

    		 Close Top of page
    End point title
    		 Complete response achieved during induction
    End point description
    Best response achieved during induction
    End point type
    Secondary
    End point timeframe
    during induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    21
    No statistical analyses for this end point

    Secondary: Complete response before entering HCT-ASCT

    		 Close Top of page
    End point title
    		 Complete response before entering HCT-ASCT
    End point description
    Best response before entering HCT-ASCT
    End point type
    Secondary
    End point timeframe
    before entering HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    18
    No statistical analyses for this end point

    Secondary: Partial response achieved during induction

    		 Close Top of page
    End point title
    		 Partial response achieved during induction
    End point description
    End point type
    Secondary
    End point timeframe
    Best response achieved during induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    52
    No statistical analyses for this end point

    Secondary: Partial response before entering HCT-ASCT

    		 Close Top of page
    End point title
    		 Partial response before entering HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    Best response before entering HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    45
    No statistical analyses for this end point

    Secondary: Partial response

    		 Close Top of page
    End point title
    		 Partial response
    End point description
    End point type
    Secondary
    End point timeframe
    Best response 30 days after HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    11
    No statistical analyses for this end point

    Secondary: Stable disease achieved during induction

    		 Close Top of page
    End point title
    		 Stable disease achieved during induction
    End point description
    End point type
    Secondary
    End point timeframe
    Best reponse achieved during induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    3
    No statistical analyses for this end point

    Secondary: Stable disease before entering HCT-ASCT

    		 Close Top of page
    End point title
    		 Stable disease before entering HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    Best response before entering HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    3
    No statistical analyses for this end point

    Secondary: Stable disease

    		 Close Top of page
    End point title
    		 Stable disease
    End point description
    End point type
    Secondary
    End point timeframe
    Best reponse 30 days after HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    0
    No statistical analyses for this end point

    Secondary: Progressive disease achieved during induction

    		 Close Top of page
    End point title
    		 Progressive disease achieved during induction
    End point description
    End point type
    Secondary
    End point timeframe
    Best reponse achieved during induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    0
    No statistical analyses for this end point

    Secondary: Progressive disease before entering HCT-ASCT

    		 Close Top of page
    End point title
    		 Progressive disease before entering HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    Best response before entering HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    7
    No statistical analyses for this end point

    Secondary: Progressive disease

    		 Close Top of page
    End point title
    		 Progressive disease
    End point description
    End point type
    Secondary
    End point timeframe
    Best response 30 days after HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Thrombocytopenia during induction

    		 Close Top of page
    End point title
    		 Toxicity: Thrombocytopenia during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    7
        Grade 3
    12
        Grade 4
    50
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Thrombocytopenia during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Thrombocytopenia during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    1
        Grade 3
    1
        Grade 4
    67
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Leucopenia during induction

    		 Close Top of page
    End point title
    		 Toxicity: Leucopenia during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    10
        Grade 3
    24
        Grade 4
    37
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Leucopenia during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Leucopenia during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    2
        Grade 3
    3
        Grade 4
    68
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Anaemia during induction

    		 Close Top of page
    End point title
    		 Toxicity: Anaemia during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    39
        Grade 3
    37
        Grade 4
    3
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Aneamia during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Aneamia during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    32
        Grade 3
    39
        Grade 4
    2
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: GPT or ALT during induction

    		 Close Top of page
    End point title
    		 Toxicity: GPT or ALT during induction
    End point description
    GPT: glutamic-pyruvic transaminase; ALT: alanine aminotransferase
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    38
        Grade 3
    27
        Grade 4
    7
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: GPT or ALT during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: GPT or ALT during HCT-ASCT
    End point description
    GPT: glutamic-pyruvic transaminase; ALT: alanine aminotransferase
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 3
    3
        Grade 4
    0
        Grade 5
    0
        Grade 1 or 2
    31
    No statistical analyses for this end point

    Secondary: Toxicity: Infections during induction

    		 Close Top of page
    End point title
    		 Toxicity: Infections during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    0
        Grade 3
    30
        Grade 4
    2
        Grade 5
    3
    No statistical analyses for this end point

    Secondary: Toxicity: Infections during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Infections during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    6
        Grade 3
    40
        Grade 4
    2
        Grade 5
    1
    No statistical analyses for this end point

    Secondary: Toxicity: Fever during induction

    		 Close Top of page
    End point title
    		 Toxicity: Fever during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    0
        Grade 3
    15
        Grade 4
    1
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Fever during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Fever during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    5
        Grade 3
    50
        Grade 4
    1
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Hyperbilirubinaemia during induction

    		 Close Top of page
    End point title
    		 Toxicity: Hyperbilirubinaemia during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    8
        Grade 3
    3
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Hyperbilirubinaemia during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Hyperbilirubinaemia during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    14
        Grade 3
    0
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Cardiac dysfunction during induction

    		 Close Top of page
    End point title
    		 Toxicity: Cardiac dysfunction during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    0
        Grade 3
    1
        Grade 4
    1
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Cardiac dysfunction during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Cardiac dysfunction during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    3
        Grade 3
    1
        Grade 4
    1
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Mucositis during induction

    		 Close Top of page
    End point title
    		 Toxicity: Mucositis during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    27
        Grade 3
    2
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Mucositis during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Mucositis during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    22
        Grade 3
    23
        Grade 4
    6
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Renal function (serum creatinine) during induction

    		 Close Top of page
    End point title
    		 Toxicity: Renal function (serum creatinine) during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    24
        Grade 3
    2
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Renal function (serum creatinine) during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Renal function (serum creatinine) during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    12
        Grade 3
    0
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Arrhythmias during induction

    		 Close Top of page
    End point title
    		 Toxicity: Arrhythmias during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    0
        Grade 3
    1
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Arrhythmias during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Arrhythmias during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    6
        Grade 3
    3
        Grade 4
    2
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Emesis during induction

    		 Close Top of page
    End point title
    		 Toxicity: Emesis during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    16
        Grade 3
    1
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Emesis during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Emesis during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    29
        Grade 3
    4
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Nausea during induction

    		 Close Top of page
    End point title
    		 Toxicity: Nausea during induction
    End point description
    End point type
    Secondary
    End point timeframe
    During induction
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    79
    Units: Number of patients
        Grade 1 or 2
    27
        Grade 3
    1
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Secondary: Toxicity: Nausea during HCT-ASCT

    		 Close Top of page
    End point title
    		 Toxicity: Nausea during HCT-ASCT
    End point description
    End point type
    Secondary
    End point timeframe
    During HCT-ASCT
    End point values
    		 Newly diagnosed primary CNS
    Number of subjects analysed
    73
    Units: Number of patients
        Grade 1 or 2
    35
        Grade 3
    12
        Grade 4
    0
        Grade 5
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Final Analysis Population A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    HCT-ASCT
    Reporting group description
    		 Patients received five courses of intravenous rituximab 375 mg/m² (7 days before first high-dose methotrexate course and then every 10 days) and four courses of intravenous high-dose methotrexate 8000 mg/m² (every 10 days) and then two courses of intravenous rituximab 375 mg/m² (day 1), cytarabine 3 g/m² (days 2 and 3), and thiotepa 40 mg/m² (day 3). 3 weeks after the last course, patients commenced intravenous HCT-ASCT (rituximab 375 mg/m² [day 1], carmustine 400 mg/m² [day 2], thiotepa 2 × 5 mg/kg [days 3 and 4], and infusion of stem cells [day 7]), irrespective of response status after induction.

    Serious adverse events
    		 HCT-ASCT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 79 (44.30%)
         number of deaths (all causes)
    13
         number of deaths resulting from adverse events
    4
    Vascular disorders
    hypertensive Krise
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tiefe Beinvenenthrombose
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    mechanische Beatmung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fieber
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Generelle Verschlechterung des physischen Gesundheitszustandes
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Schleimhautentzuendung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ulkus
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    verzoegerte Heilung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lungenembolie
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    respiratorische Insuffizienz
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Substanzbedingte psychotische Stoerung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Wahnstoerung, unbestimmter Typ
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    C-reaktives Protein erhoeht
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia-Test positiv
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Koerpertemperatur erhoeht
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Kreatinin im Blut erhoeht
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fistel nach einem Eingriff
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frakturen von Gesichtsknochen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sturz
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arrhythmie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Koronararterienverschluss
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    akuter Myokardinfarkt
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Ataxie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal Konvulsion
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hemiparese
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hydrozephalus
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kleinhirnsyndrom
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Konvulsion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stammhirnsyndrom
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subarachnoidalblutung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukopenie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombozytopenie
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoe
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erbrechen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uebelkeit
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxisch
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    akute Cholezystitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Ausschlag mit Juckreiz
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nierenversagen akut
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Geraetebedingte Sepsis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Harnwegsinfektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hordeolum
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infektion im Zusammenhang mit einem medizinischen Geraet
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Klebsiella-Sepsis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii-Pneumonie
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    Pneumonie
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonie durch Pseudomonas
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Sepsis durch Staphylokokken
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    akute Tonsillitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    bronchopulmonale Aspergillose
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pulmonale Sepsis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HCT-ASCT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 79 (44.30%)
    Vascular disorders
    Jugularvenenthrombose
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Thrombose
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Varizen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Venenthrombose einer Extremitaet
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Surgical and medical procedures
    Zahnextraktion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenie
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Fieber
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Oedem
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Schmerz
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    generalisierte Oedeme
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    unerwuenschte Arzneimittelwirkung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Immune system disorders
    Immundefekt
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Ueberempfindlichkeit
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Metrorrhagie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dyspnoe
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Lungenembolie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Schluckauf
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Psychiatric disorders
    Angst
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Schlafstoerung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Verwirrtheitszustand
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Investigations
    Bilirubin im Blut erhoeht
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gewicht erhoeht
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Laktatdehydrogenase im Blut erhoeht
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    subkutanes Haematom
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Cardiac disorders
    Sinustachykardie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Nervous system disorders
    Affektion der Meningen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Aufmerksamkeitsstoerungen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hemianopie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Konvulsion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Kopfschmerz
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Paraesthesie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Lagerungsvertigo
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Eye disorders
    Sehen verschwommen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Sehverschlechterung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastrointestinal disorders
    Blutstuhl
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Darmdivertikel haemorrhagisch
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Diarrhoe
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Enterokolitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Erbrechen
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    3
    Gastritis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Ileus spastisch
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Pankreatitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Subileus
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Uebelkeit
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    3
    gastrointestinale Entzuendung
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hepatobiliary disorders
    Steatosis hepatis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythem
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Hautlaesion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Pruritus generalisiert
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Urtikaria
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    makuloeser Ausschlag
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgie
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Bursitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Rueckenschmerzen
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Schmerz in einer Extremitaet
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Schmerzen des Muskel- und Skelettsystems
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Clostridium difficile-Kolitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Erysipel
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastroenteritis durch Norovirus
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastrointestinalinfektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Harnwegsinfektion
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Herpesvirus-Infektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Infektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Pneumonie
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Septischer Schock
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Staphylokokkeninfektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    bakterielle Infektion
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    oraler Herpes
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    pseudomembranoese Kolitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Fluessigkeitsretention
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2008
    In addition to chemotherapy, the monoclonal antibody rituximab is administered to all patients with CD-20 positive primary cerebral lymphomas. The side effects of AraC listed in the introduction were complemented and the side effects of Thiotepa corrected. The timepoint for lumbar puncture were corrected. The remission criteria of Macdonald et al were replaced by the remission criteria established by the International Primary CNS Lymphoma Collaborative Group (IPCG) specifically for PCNSL. The target criteria evaluation is not affected by this.
    29 Jul 2009
    Study population: Number of paticipants was increased from 39 to 80.

    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/27476790
    http://www.ncbi.nlm.nih.gov/pubmed/28559537
    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.

    European Medicines Agency © 1995-Wed Apr 17 01:03:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA