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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35236   clinical trials with a EudraCT protocol, of which   5759   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).
     
    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

    Print Download

    Summary
    EudraCT Number:2016-001628-72
    Sponsor's Protocol Code Number:P001317
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2017-04-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-001628-72
    A.3Full title of the trial
    Age-adjusted high-dose chemotherapy and autologous stem cell transplant in elderly and fit primary CNS lymphoma patients
    Altersadaptierte Hochdosistherapie gefolgt von autologer Stammzelltransplantation bei fitten älteren Patienten mit Erstdiagnose eines primär zerebralen Lymphoms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The principal objective of the study is to investigate tolerability of highdose
    chemotherapy and autologous stem cell transplant in elderly patients
    older than 65 years with newly-diagnosed or relapsed primary lymphomas
    of the central nervous system.
    Die geplante klinische Studie beschäftigt sich mit der Verträglichkeit einer
    Hochdosischemotherapie und autologer Stammzelltransplantation bei
    älteren Patienten über 65 Jahre mit neu diagnostizierten oder Rückfällen
    von bösartigen primären Lymphomen des zentralen Nervensystems.
    A.3.2Name or abbreviated title of the trial where available
    MARTA
    MARTA
    A.4.1Sponsor's protocol code numberP001317
    A.5.4Other Identifiers
    Name:DRKSNumber:00011932
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical Center - University of Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportElse Kröner-Fresenius-Stiftung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg, Abt. Med I
    B.5.2Functional name of contact pointDr. med. Elisabeth Schorb
    B.5.3 Address:
    B.5.3.1Street AddressHugstetter Straße 55
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79110
    B.5.3.4CountryGermany
    B.5.4Telephone number0049761270-35360
    B.5.5Fax number0049761270-33110
    B.5.6E-mailelisabeth.schorb@uniklinik-freiburg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.9.1CAS number 59-05-2
    D.3.9.3Other descriptive nameMTX, IUPAC: (2S)-2-[(4-{[(2,4-Diaminopteridin-6-yl)methyl](methyl)amino}benzoyl)amino]pentanedioic acid
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCytarabine
    D.3.9.1CAS number 147-94-4
    D.3.9.3Other descriptive nameCytosine Arabinoside, Arabinofuranosylcytosin, Ara-C, IUPAC: 4-amino-1- [(2R,3S,4R,5R)-3,4-dihydroxy-5- (hydroxymethyl)oxolan-2-yl] pyrimidin-2-one
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHIOTEPA
    D.3.9.1CAS number 52-24-4
    D.3.9.3Other descriptive nameIUPAC: 1,1',1''-phosphorothioyltriaziridine
    D.3.9.4EV Substance CodeSUB10985MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUSULFAN
    D.3.9.1CAS number 55-98-1
    D.3.9.3Other descriptive nameBU, IUPAC: Butane-1,4-diyl dimethanesulfonate
    D.3.9.4EV Substance CodeSUB05993MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary central nervous system lymphoma (PCNSL) is an aggressive
    Non-Hodgkin Lymphoma (NHL) mostly of B-cell origin, which exclusively
    invades the central nervous system compartment. It accounts for 3% to
    4% of all primary brain tumours and 4% to 6% of extra-nodal
    lymphomas. The incidence of PCNSL in immunocompetent patients has
    been steadily increasing over the last 30 years. Patients older than 60
    years account for more than 50% of all PCNSL cases.
    Das primär zerebrale Non-Hodgkin-Lymphom (PCNSL) tritt überwiegend
    bei Patienten > 60 Jahre auf und zeichnet sich biologisch als hochaggressiv wachsender Tumor entsprechend dem systemischen hochmalignen Non-Hodgkin-Lymphom (NHL) mit einem medianen Überleben von nur wenigen Monaten aus. Die Inzidenz ist sowohl bei immunsuppremierten als auch bei immunkompetenten Patienten in den
    letzten Jahren steigend.
    E.1.1.1Medical condition in easily understood language
    Primary central nervous system lymphoma is an aggressive Non-Hodgkin
    Lymphoma, which exclusively invades the central nervous system
    compartment.
    Es handelt sich hier um eine bösartige Erkrankung des lymphatischen
    Systems im Bereich des Gehirns und/oder des Rückenmarks. Ein
    sogenanntes malignes Non-Hodgkin-Lymphom des
    Zentralnervensystems.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to investigate the efficacy of age-adapted induction treatment followed by high-dose chemotherapy and autologous stem cell transplantation regarding 1-year PFS in elderly and fit patients with primary CNS lymphoma.
    Das primäre Studienziel ist die Beurteilung der Wirksamkeit der altersadaptierten Hochdosistherapie gefolgt von autologer Stammzelltransplantation bei fitten älteren Patienten mit Erstdiagnose eines primär zerebralen Lymphoms, an Hand des Progressionsfreien Überlebens nach einem Jahr.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the investigation of OS, treatment response (rate of complete responses on day 30 after HDT-ASCT) and treatment related morbidities (neurotoxicity and adverse advents).
    Sekundäre Studienziele sind: Bewertung der Progressionsfreien Überlebenszeit im Verlauf, Bewertung des Gesamtüberlebens, Bewertung der Rate kompletter Remissionen am Tag +30 nach HDT-ASZT, Bewertung der Neurotoxizitätsraten, Bewertung der Toxizitätsraten, Bewertung der Raten von Unerwünschten Ereignissen und Schweren Unerwünschten Ereignissen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma.
    2. Age > 65 years not eligible for treatment within the MATRix/IELSG43 trial.
    3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
    4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
    5. Disease exclusively located in the CNS.
    6. At least one measurable lesion.
    7. ECOG-Performance Status ≤ 2.
    8. Patients eligible for intensive treatment according to physician´s choice.
    9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease.
    1. Immunkompetente Patienten mit Erstdiagnose oder zentralem Rezidiv eines primären
    B-Zell-Lymphoms des zentralen Nervensystems.
    2. Alter > 65 Jahre sowie Patienten zwischen 65 und 70 Jahren, die nicht für eine
    Behandlung innerhalb der MATRix/IELSG32-Studie in Frage kommen.
    3. Histologisch oder zytologisch gesicherte Diagnose eines primären B-Zell-Lymphoms des zentralen Nervensystems durch die lokale Pathologie.
    4. Diagnosensicherung mittels stereotaktischer oder offener Biopsie, Liquorzytologie oder Vitrektomie.
    5. Krankheitslokalisation ausschließlich in ZNS
    6. Mindestens eine messbare Läsion.
    7. ECOG-Performance Status ≤ 2.
    8. Patienten, die sich nach Einschätzung des Prüfarztes für die intensive Therapie qualifizieren
    9. Unterzeichnung der Einwilligungserklärung entsprechend internationaler Richtlinien und nationaler Gesetzgebung durch den Patienten oder – für den Fall, dass der Patient dazu krankheitsbedingt nicht in der Lage ist - einen autorisierten gesetzlichen Vertreter.
    E.4Principal exclusion criteria
    1. Congenital or acquired immunodeficiency.
    2. Systemic lymphoma manifestation (outside the CNS).
    3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord.
    4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years.
    5. Previous systemic Non-Hodgkin lymphoma at any time.
    6. Inadequate renal function (creatinine clearance <60 ml/min).
    7. Inadequate hepatic, cardiac or pulmonary function according to physician`s decision.
    8. Active hepatitis B or C disease.
    9. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency.
    10. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study.
    11. Third space fluid accumulation >500 ml.
    12. Hypersensitivity to study treatment or any component of the formulation.
    13. Taking any medications likely to cause interactions with the study medication.
    14. Known or persistent abuse of medication, drugs or alcohol.
    15. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative.
    16. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator.
    17. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    1. Kongenitale oder erworbene Immunschwäche.
    2. Systemische Lymphom-Manifestation (außerhalb des ZNS).
    3. Isoliertes okuläres Lymphom ohne Manifestation im Hirnparenchym oder im
    Rückenmark.
    4. Andere bösartige Erkrankungen; ausgenommen sind chirurgisch entfernte Karzinome in situ der Zervix, Karzinome der Haut und andere bösartige Tumoren, die sich seit mindestens 5 Jahren in kompletter Remission befinden.
    5. Systemisches Non-Hodgkin Lymphom in der Vergangenheit.
    6. Inadäquate Nierenfunktion (Kreatinin-Clearance < 60 ml/min).
    7. Inadäquate Leber-, Herz- oder Lungenfunktion entsprechend der Einschätzung des Prüfarztes
    8. Aktive Hepatitis B oder C Erkrankung.
    9. HIV Infektion, frühere Organtransplantation oder andere klinisch evidente Formen der Immunschwäche.
    10. Laufende Behandlung mit anderen Studienmedikamenten oder Teilnahme an einer klinischen Studie innerhalb der letzten 30 Tage vor Beginn dieser Studie.
    11. Flüssigkeitsansammlung im 3. Raum > 500 ml.
    12.Überempfindlichkeit gegenüber der Studienmedikation oder einem anderen
    Bestandteil der Behandlung.
    13. Einnahme von Medikamenten, die mit großer Wahrscheinlichkeit zu
    Wechselwirkungen mit der Studienmedikation führen.
    14. Bekannter oder anhaltender Missbrauch von Arzneimitteln, Drogen oder Alkohol.
    15. Nicht geschäftsfähiger Patient, der Art, Bedeutung und Konsequenzen der Studie nicht erfassen kann und keinen gesetzlichen Betreuer hat.
    16. Personen, die sich in einem Abhängigkeitsverhältnis zum Sponsor und/oder Prüfarzt befinden.
    17. Jeglicher familiärer, soziologischer oder geographischer Umstand, der potentiell die ordnungsgemäße und protokollgerechte Durchführung der Studie und der Nachbeobachtung gefährdet.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: progression free survival (PFS) at 1 year
    Primärer Endpunkt: 1 Jahres-Rate des Progressionsfreies Überleben (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from start of treatment until disease progression or death from any cause, whichever occurs first.
    Ab dem Zeitpunkt des Therapiestarts bis zum Progress, Rezidiv oder Tod
    E.5.2Secondary end point(s)
    Key secondary endpoint(s):
    • Rate of complete responses (CR)
    • Progression-free survival (PFS)
    • Overall survival (OS)
    • Rate of neurotoxicity
    • Non relapse mortality (NRM)
    • (Serious) adverse events ([S]AEs)
    • Toxicity
    Sekundäre Endpunkte:
    • Komplette Remission (CR)
    • Progressionsfreies Überleben (PFS)
    • Gesamtüberleben (OS)
    • Neurotoxizitätsrate
    • Non relapse mortality (NRM)
    • (Schwerwiegende) unerwünschte Ereignisse (SUEs)
    • Toxizität
    E.5.2.1Timepoint(s) of evaluation of this end point
    CR: on day +30 after HDT-ASCT
    PFS: as time from start of treatment until progression, relapse or death from any cause, whatever happens first
    OS: as time from start of treatment until death from any cause
    Rate of Neurotoxocity: on day + 30 after HDT-ASCT and continuously thereafter
    Non relapse mortality (NRM): coutinously
    SAEs: from the first administration of the study medication until day 30 after HDT-ASCT
    Toxicity: continously
    CR: am Tag +30 nach HDT-ASZT
    Progressionfreies Überleben (PFS): ab dem Zeitpunkt des Therapiestarts bis zum Progress, Rezidiv oder Tod
    Gesamtüberleben (OS): ab dem Zeitpunkt des Therapiestarts bis zum Tod
    Neurotoxizitätsrate: an Tag + 30 nach HDT-ASZT und danach in regelmäßigen Abständen
    Non relapse mortality (NRM)
    SUEs: von der ersten Medikamentengabe bis Tag 30 nach HDT-ASZT
    Toxizität: in regelmäßigen Abständen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to PCNSL some patients might be temporarily incapable of giving
    consent personally. In this case a legal representative signs the PIC. In
    the course of the treatment the patients usually regain their
    intellectual capabilities and sign the PIC.
    Bedingt durch das ZNS-Lymphom kann es sein, dass Patienten
    vorübergehend kognitiv eingeschränkt sind und eine Geschäftsfähigkeit
    zeitweilig nicht besteht. In diesem Fall unterschreibt ein gesetzlicher
    Vertreter die Patienteninformation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 51
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Follow up per patient: 1 year; thereafter annual control examinations are strongly recommended
    Nachbeobachtungszeit (Follow Up): 12 Monate, danach wird die jährliche Nachbeobachtung dringend empfohlen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA