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    Summary
    EudraCT Number:2014-001532-11
    Sponsor's Protocol Code Number:01apr2014
    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:2014-07-28
    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 number2014-001532-11
    A.3Full title of the trial
    MONO-INSTITUTIONAL PHASE II TRIAL ADDRESSING TOLERABILITY AND ACTIVITY OF R-CHOP CHEMOIMMUNOTHERAPY PRECEDED BY BLOOD-BRAIN BARRIER PERMEABILIZATION BY NGR-TUMOR NECROSIS FACTOR IN PATIENTS WITH RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
    STUDIO MONOCENTRICO DI FASE II DI TOLLERABILITA’ ED EFFICACIA DI CHEMIO-IMMUNOTERAPIA CON R-CHOP PRECEDUTA DA PERMEABILIZZAZIONE DELLA BARRIERA EMATO-ENCEFALICA CON NGR-TUMOR NECROSIS FACTOR IN PAZIENTI AFFETTI DA LINFOMA PRIMITIVO CEREBRALE RECIDIVATO O REFRATTARIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACTIVITY OF R-CHOP CHEMOIMMUNOTHERAPY BY NGR-TUMOR NECROSIS FACTOR IN PATIENTS WITH RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
    A.3.2Name or abbreviated title of the trial where available
    Ingrid
    A.4.1Sponsor's protocol code number01apr2014
    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 SponsorOspedale San Raffaele
    B.1.3.4CountryItaly
    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 supportOspedale San Raffaele
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointLymphoid malingnancies Unit Data Ma
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina 60
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number+390226433919
    B.5.5Fax number+390226434760
    B.5.6E-mailferreri.andres@hsr.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 No
    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.3.1Product nameARENEGYR
    D.3.2Product code Ngr-TNF
    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 INNnon disponibile
    D.3.9.1CAS number Not applicab
    D.3.9.2Current sponsor codeNGR-TNF
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.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 non-Hodgkin lymphoma in the central nervous system relapse / refractory
    Linfoma non Hodgkin primitivo del Sistema nervoso centrale in ricaduta/refrattario
    E.1.1.1Medical condition in easily understood language
    cancer of the lymphocytes localized exclusively at the level of the central nervous system unresponsive or relapsed after at least one line of therapy
    tumore dei linfociti localizzato esclusivamente a livello del sistema nervoso centrale non responsivo o ricaduto dopo almeno una linea di terapia
    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
    feasibility of chemo-immunotherapy with standard R-CHOP preceded by Ngr-TNF
    fattibilità di chemio-immunoterapia standard con R-CHOP preceduta da Ngr-TNF
    E.2.2Secondary objectives of the trial
    Tolerability, overall response, duration of response, bioavailability of drugs in the cerebrospinal fluid after permealizzazione membrane of the blood-brain with ngr-TNF, Overall Survival
    Tollerabilità, Risposta globale, Durata della risposta, Biodisponibilità dei farmaci nel liquido cefalorachidiano dopo permealizzazione della membrana emato-encefalica con ngr-TNF, Sopravvivenza globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with primary brain lymphoma in relapsed or refractory after first-line chemotherapy based on high-dose methotrexate
    2. Disease exclusively confined to the central nervous system with the presence of at least one bi-dimensionally measurable lesion
    3. Aged between 18 and 80 years and ECOG performance status <4
    4. Adequate bone marrow function (platelets> 75000/mmc, hemoglobin> 8 g / dL, neutrophils> 1000/mmc), renal (serum creatinine <2.2 mg / dL and creatinine clearance> = 40 mL / min), cardiac (FE> = 50%), hepatic (SGOT / SGPT <3 times the upper normal value, bilirubin and alkaline phosphatase <2 times the upper normal value)
    5. Written informed consent from the patient or a family member if the patient is incapacitated due to disease-related cognitive deficits
    1. pazienti affetti da linfoma cerebrale primitivo in recidiva o refrattari dopo chemioterapia di prima linea a base di methotrexate ad alte dosi
    2. malattia esclusivamente limitata al sistema nervoso centrale con presenza di almeno una lesione misurabile bidimensionalmente
    3. età compresa tra 18 e 80 anni e performance status ECOG < 4
    4. adeguata funzione midollare (piastrine > 75000/mmc, emoglobina > 8 g/dL, neutrofili > 1000/mmc), renale (creatinina sierica < 2.2 mg/dL e clearance creatinina >= 40 mL/min), cardiaca (FE >= 50%), epatica (SGOT/SGPT < 3 volte il valore superiore di normalità, bilirubina e fosfatasi alcalina < 2 volte il valore superiore di normalità)
    5. consenso informato scritto dal paziente o da un familiare in caso il paziente sia incapacitato a causa di deficit cognitivo legato alla malattia
    E.4Principal exclusion criteria
    1. Chronic HIV positive or other immune deficiencies
    2. Comorbidities that might prevent the deadlines set by the study (eg, severe heart disease)
    3. Concomitant treatment with other antineoplastic drugs
    4. Pregnant or breastfeeding. Women of childbearing potential not employing adequate contraception during study participation
    5. Previous or concomitant other malignancies diagnosed or relapsed during the last 3 years, with the exception of in situ cancers treated surgically and basal cell carcinomas of the skin
    6. Whatever the psychosocial, familial, sociological or geographical potentially limiting compliance to the study
    1. HIV positività o altre immunodeficienze croniche
    2. patologie concomitanti che potrebbero impedire il rispetto dei tempi previsti dallo studio (es. gravi cardiopatie)
    3. trattamento concomitante con altri farmaci antineoplastici
    4. stato di gravidanza o allattamento. Donne in età fertile non utilizzanti adeguati metodi contraccettivi durante la partecipazione allo studio
    5. altre neoplasie precedenti o concomitanti diagnosticate o recidivate durante gli ultimi 3 anni, ad eccezione di carcinomi in situ trattati chirurgicamente e carcinomi basocellulari della cute
    6. qualsiasi condizione psicosociale, familiare, sociologica o geografica potenzialmente limitativa della compliance allo studio
    E.5 End points
    E.5.1Primary end point(s)
    feasibility of an experimental treatment consisting of R-CHOP chemoimmunotherapy preceded by Blood Brain Barrier Permeabilization (BBBP) by NGR-Tumor Necrosis Factor (NGR-hTNF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    tolerability, drug bioavailability in CSF, overall response rate, response duration, overall survival
    E.5.2Secondary end point(s)
    end of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of treatment
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    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
    CNS pathology secondary to tumor treatment
    patologia SNC secondaria al tumore in trattamento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    Not applicable
    Non applicabile
    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 Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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