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    Summary
    EudraCT Number:2016-003116-12
    Sponsor's Protocol Code Number:IELSG45
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003116-12
    A.3Full title of the trial
    Randomized Phase II Trial on Fitness- and Comorbidity- Tailored Treatment in Elderly Patients with Newly Diagnosed Primary CNS Lymphoma (FIORELLA Trial)
    Studio clinico di Fase II randomizzato sul trattamento personalizzato (sulla base di fitness e comorbidità) dei pazienti anziani con linfoma primitivo del sistema nervoso centrale di nuova diagnosi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Phase II Trial on Tailored Treatment in Elderly Patients with Newly Diagnosed Primary CNS Lymphoma (FIORELLA Trial)
    Studio clinico di Fase II randomizzato sul trattamento personalizzato dei pazienti anziani con linfoma primitivo del sistema nervoso centrale di nuova diagnosi.
    A.3.2Name or abbreviated title of the trial where available
    FIORELLA trial / IELSG45
    Studio FIORELLA / IELSG45
    A.4.1Sponsor's protocol code numberIELSG45
    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 SponsorIELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
    B.1.3.4Country
    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 supportCelgene
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE ITALIANA LINFOMI ONLUS
    B.5.2Functional name of contact pointBorgo Elena
    B.5.3 Address:
    B.5.3.1Street AddressVIA DEL POZZO 71
    B.5.3.2Town/ cityMODENA
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225845
    B.5.5Fax number0594223602
    B.5.6E-mailstartup@filinf.it
    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.2.1.1.1Trade name REVLIMID - 25 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberDLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
    D.3 Description of the IMP
    D.3.1Product nameREVLIMID/LENALIDOMIDE
    D.3.2Product code [1]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeLENALIDOMIDE
    D.3.9.3Other descriptive nameLENALIDOMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantineoplastico immunomodulatore
    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.2.1.1.1Trade name REVLIMID - 5 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CASPULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberDLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
    D.3 Description of the IMP
    D.3.1Product nameLENALIDOMIDE/REVLIMID
    D.3.2Product code [2]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenalidomde
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeLenalidomide
    D.3.9.3Other descriptive nameLenalidomide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeANTINEOPLASTICO E IMMUNOMODULATORE
    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.2.1.1.1Trade name REVLIMID - 10 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberDLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
    D.3 Description of the IMP
    D.3.1Product nameLENALIDOMIDE/REVLIMID
    D.3.2Product code [3]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenalidomide
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeLenalidomide
    D.3.9.3Other descriptive nameLenalidomide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeANTINEOPLASTICO E IMMUNOMODULATORE
    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
    Patients with newly diagnosed primary central nervous system lymphoma with age =70 years old
    Pazienti di nuova diagnosi con linfoma primitivo del sistema nervoso centrale con età > uguale a 70 anni
    E.1.1.1Medical condition in easily understood language
    Patients with a diagnosis of primary central nervous system lymphoma with age =70 years old
    Pazienti in cui è stato diagnosticato un linfoma primitivo del sistema nervoso centrale e hanno un età uguale o maggiore di 70 anni
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10007953
    E.1.2Term Central nervous system lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PART A, randomized
    To compare the efficacy of a new maintenance treatment consisting of oral lenalidomide with the oral procarbazine maintenance currently in use, in elderly (=70 years) patients with newly diagnosed PCNSL eligible to receive HD-MTX-based induction chemo-immunotherapy. The primary efficacy endpoint is the 2-year PFS
    Part B, non randomized
    To evaluate the efficacy of concomitant chemo-immuno-radiotherapy administered as induction treatment, followed by temozolomide maintenance in elderly (=70 years) patients with newly diagnosed PCNSL ineligible to receive HD-MTXbased induction chemo-immunotherapy.The primary efficacy endpoint is the 2-year PFS
    PARTE A, Randomizzata
    È quello di confrontare l'efficacia di un nuovo trattamento di mantenimento costituito da lenalidomide o procarbazina (attualmente in uso), somministrate per via orale, in pazienti anziani (= 70 anni) con nuova diagnosi di PCNSL, idonei a ricevere alte dosi di metotressato durante la fase di induzione.
    L'obiettivo primario di efficacia è la percentuale di PFS a 2 anni.
    PARTE B, non randomizzara
    è quello di valutare l'efficacia della chemio-immunoradioterapia somministrata come trattamento di induzione, seguita da una fase di mantenimento con temozolomide in pazienti anziani (= 70 anni) con nuova diagnosi di PCNSL, non idonei a ricevere durante la fase di induzione alte dosi di metotressato.
    L'endpoint primario di efficacia è la PFS a 2 anni.
    E.2.2Secondary objectives of the trial
    PART A, Randomized:
    To evaluate: The ability of the induction and maintenance treatment to induce
    objective tumor responses; Duration of response; Relapse rates and patterns; Overall survival, Incidence and severity of adverse events and adverse reactions.
    Prognostic role of geriatric assessments: CIRS, IADL, ADL, and G8.

    Part B, non randomized:
    To evaluate: The ability of the induction and maintenance treatment to induce objective tumor responses; Duration of response; Relapse rates and patterns; Overall survival, Incidence and severity of adverse events and adverse reactions.
    Prognostic role of geriatric assessments: CIRS, IADL, ADL, and G8.
    PARTE A; randomizzata:
    sono confrontare l'effetto di lenalidomide e procarbazina durante il mantenimento in termini di: Durata della risposta (remissione parziale [PR] e remissione completa [CR]); Sopravvivenza globale; Percentuale di Profilo di sicurezza, Neurotossicità precoce e tardiva, incidenza e gravità degli eventi avversi
    Ruolo prognostico della valutazione Geritatrica: CIRS, IADL, ADL e G8

    Parte B non randomizzata:
    Capacità da parte del trattamento di induzione e di mantenimento a indurre risposte tumorali obiettive; Durata della risposta; Percentuale e tipo di ricaduta; Sopravvivenza globale, Neurotossicità precoce e tardiva; incidenza e gravità degli eventi avversi
    Ruolo prognostico della valutazione Geritatrica: CIRS, IADL, ADL e G8
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Life quality
    Version: 3.0
    Date: 01/09/2017
    Title: Quality of life
    Objectives: questionnaire to assess the quality of life

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: translational study protocol V2 17.08.18 to evaluate the cell of origin (COO)

    Qualita' della vita
    Versione: 3.0
    Data: 01/09/2017
    Titolo: EORTC QLQ-C30
    Obiettivi: questionario qualità della vita

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: studi traslazionali protocollo V2 17.08.18 per determinare la cell of origin (COO)
    E.3Principal inclusion criteria
    - Histologically or cytologically assessed diagnosis of CD20+ diffuse large B-cell lymphoma.
    - Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
    - Lymphoma exclusively localized in the central nervous system (brain parenchyma and/or meningeal/CSF dissemination and/or eyes and/or cranial nerves).
    - Previously untreated patients (previous or ongoing steroid therapy admitted).
    - Age =70 years
    - Patients not eligible for high-dose chemotherapy supported by autologous stem cell transplant
    - ECOG PS =3.
    - Adequate bone marrow, cardiac, renal, and hepatic function
    - No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least for 3 years (patients with a previous lymphoma at any time are NOT eligible).
    - Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    - No concurrent treatment with other experimental drugs.
    - Patients receiving oral lenalidomide or procarbazine must agree to avoid sharing the study medication with another person and to return all unused study drug to the investigator.
    - Male patients must agree to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide, during dose interruptions and for up to 7 days after treatment discontinuation, even if they have undergone a successful vasectomy.
    - Informed consent from the patient, or legal representative, obtained before registration.
    - Diagnosi istologica o citologica di linfoma diffuso a grandi cellule B CD20+.
    - Campione diagnostico ottenuto mediante biopsia stereotassica o chirurgica, esame citologico del liquido cerebrospinale o vitrectomia.
    - Linfoma esclusivamente localizzato nel sistema nervoso centrale (parenchima cerebrale e/o meningeo e/o diffusione nel liquido cerebrospinale e/o occhi e/o nervi cranici).
    - Pazienti non trattati precedentemente (precedente o attuale terapia steroidea ammessa).
    - Età =70 anni
    - Pazienti non eleggibili ad alte dosi di chemioterapico supportati da trapianto di cellule staminali autologhe.
    - ECOG PS =3.
    - Funzionalità midollare, cardiaca, renale ed epatica adeguate
    - Nessuna neoplasia precedente o concomitante ad eccezione del carcinoma della cervice chirurgicamente curato in-situ, carcinoma della pelle o altri tipi di tumore, senza evidenza di malattia per almeno 3 anni (pazienti con un precedente linfoma NON sono ammissibili).
    - Assenza di qualsiasi condizione familiare, sociologica o geografica potenzialmente ostacolante in accordo con il protocollo di studio e il programma di follow-up.
    - Nessun trattamento concomitante con altri farmaci sperimentali.
    - Pazienti che ricevono lenalidomide o procarbazina per via orale devono accettare di evitare di condividere il farmaco in studio con un’altra persona e devono restituire tutto il farmaco inutilizzato al medico di studio
    - I pazienti di sesso maschile devono accettare di usare sempre il preservativo durante qualsiasi rapporto sessuale con donne potenzialmente fertili mentre assumono lenalidomide e durante le interruzioni di dose, per un massimo di 7 giorni dopo la sospensione del trattamento, anche se hanno subito una vasectomia.
    - Il consenso informato deve essere ottenuto dal paziente o legale rappresentativo prima della registrazione
    E.4Principal exclusion criteria
    - Lymphoma entity other than diffuse large B-cell lymphoma.
    - Extra-CNS disease.
    - Lymphoma exclusively localized in the eyes
    - Lymphoma infiltration of the cranial nerves as exclusive site of disease
    - Previous antineoplastic treatment for the PCNSL.
    - Patients eligible for ASCT.
    - HBsAg- and HCV-positive patients; HBsAg- and HCV-positive patients. HBcAb+ is not exclusion criteria in the absence of detectable levels HBVDNA.
    - HIV disease or immunodeficiency.
    - Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus despite optimal medical management).
    - Active infectious disease.
    - Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the Summary of Product Characteristics (SmPCs) of the anticancer drugs used in the study
    - Linfoma diverso da quello diffuso a grandi cellule B
    - Malattie extra-SNC
    - Linfoma localizzato esclusivamente agli occhi
    - Infiltrazione del linfoma nei nervi cranici come luogo esclusivo di malattia
    - Precedente trattamento antineoplastico per il PCNSL
    - Pazienti che possono beneficiare di ASCT
    - Pazienti HBsAg- e HCV- positivi; pazienti HBsAg- e HCV- positivi; HBcAb+ non è da considerarsi un criterio di esclusione se in assenza di livelli rilevabili di HBVDNA
    - HIV o immunodeficienza
    - Gravi malattie concomitanti/condizioni mediche (ad esempio attività respiratoria compromessa e/o funzione cardiaca, diabete mellito non controllato nonostante terapia medica).
    - Malattia infettiva attiva
    - Ipersensibilità a qualsiasi principio attivo e/o qualsiasi eccipiente secondo le controindicazioni riportate nel Riassunto delle Caratteristiche del Prodotto (RCP) dei farmaci antitumorali utilizzati nello studio
    E.5 End points
    E.5.1Primary end point(s)
    It is the 2-year progression-free survival rate. Progression-free survival will be calculated from maintenance treatment start to relapse/progression or death due to any cause, whichever occurs earlier.
    é la percentuale di sopravvivenza libera da progressione a 2 anni. La sopravvivenza libera da progressione sarà calcolata dall’inizio del trattamento di mantenimento alla ricaduta/progressione o alla morte per qualsiasi causa, a seconda di cosa si verifichi prima
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    E.5.2Secondary end point(s)
    1. Duration of response (Partial remission [PR] and Complete Remission [CR])
    2. Overall survival
    3. Relapse rates and patterns
    4. Safety profile
    5. Early and late neurotoxicity; Prognostic Role of geriatric assessments: CIRS, IADL, ADL and G8.
    1. Durata della risposta (remissione parziale [PR] e remissione completa
    [CR])
    2. Sopravvivenza globale
    3. Percentuale di ricaduta
    4. Profilo di sicurezza
    5. Neurotossicità precoce e tardiva
    ; Ruolo prognostico della valutazione Geriatrica: CIRS, IADL, ADL, e G8
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months; Before the treatment
    30 mesi; Prima del trattamento
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 90
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 208
    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)
    The clinical trial has not providet treatments after it. Tharapy will be continueld by physician discrection following the the standard therapies
    il protocollo non prevede specifici programmi. Si proseguirà a descrizione del medico curante e secondo pratica clinica
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Istituto San Raffaele
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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