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    Summary
    EudraCT Number:2011-004908-37
    Sponsor's Protocol Code Number:IRIS
    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:2011-12-28
    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 number2011-004908-37
    A.3Full title of the trial
    Phase II study on activity and tolerability of intralesional rituximab in relapsed or refractory patients affected by indolentCD-20 positive lymphoma of conjuntiva; evaluation of activity of adding autologous serum in non-responding patients to ritiximab alone.
    Studio di fase II sull'attivita' e tollerabilita' con Rituximab intralesionale in pazienti affetti da linfomi infolenti CD20 positivi della congiuntiva recidivati o refrattari a trattamenti convenzionali; valutazione dell'attivita' dell'impiego aggiuntivo di siero autologo nei pazienti non responsivi al solo Rituximab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of intraconjuntival treatment with Rituximab in patients affected by NH lymphoma of conjunctiva.
    Valutazione del trattamento con rituximab intracongiuntivale in pazienti affetti da linfoma non Hodgkin della congiuntiva.
    A.4.1Sponsor's protocol code numberIRIS
    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 SponsorFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    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 supportnessun finanziamento previsto
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione San Raffaele del Monte Tabor
    B.5.2Functional name of contact pointUnita' Linfomi
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina,60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02-26437649
    B.5.5Fax number02-26437603
    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 Yes
    D.2.1.1.1Trade name MABTHERA*EV 2F 10ML 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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 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 IMPIntralesional 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.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
    indolent CD-20 positive lymphoma of conjunctiva
    linfomi indolenti CD20 positivi della congiuntiva
    E.1.1.1Medical condition in easily understood language
    lymphoma of conjunctiva
    linfomi della congiuntiva
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's 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
    to evaluate the safety of intralesional rituximab in patients with CD20 + indolent lymphomas of the conjunctiva
    valutare la sicurezza del rituximab intralesionale in pazienti affetti da linfomi indolenti CD20+ della congiuntiva
    E.2.2Secondary objectives of the trial
    -to assess the activity of intralesional rituximab in the treatment of CD20 + indolent lymphomas of the conjunctiva in terms of response and duration of response. -to evaluate the clinical impact of adding rituximab to autologous serum in terms of clinical response in patients unresponsive to intralesional rituximab alone.
    -valutare l’attività del rituximab intralesionale nel trattamento dei linfomi indolenti CD20+ della congiuntiva in termini di risposta e durata della risposta. -valutare l’impatto clinico dell’aggiunta del siero autologo al rituximab in termini di risposta clinica, nei pazienti non responsivi al solo rituximab intralesionale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histological diagnosis of CD20 + B-cell lymphoma subtypes: marginal zone lymphoma, follicular lymphoma grade 1-2, linfoplasmocitico lymphoma, small cell lymphoma-location only conjunctival (stage IEA, unilateral or bilateral). -at least one lesion measurable / configurable. -age > or equal 18 years-ECOG-PS < 3-HIV 1-2 negative -at least one line of previous treatment (considering doxycycline and ceftriaxone when administered as a therapeutic line for more than two consecutive weeks and rituximab administered intravenously over at least 3 doses) -signed written informed consent
    -Diagnosi istologica di linfoma a cellule B CD20+, sottotipi: linfoma della zona marginale, linfoma follicolare grado 1-2, linfoma linfoplasmocitico, linfoma a piccoli linfociti -localizzazione esclusivamente congiuntivale (stadio IEA; mono- o bilaterale). -almeno una lesione misurabile/parametrabile. -età &gt; o uguale a 18 anni -ECOG-PS &lt; 3 -HIV 1-2 negatività -almeno una linea di trattamento precedente (considerando doxiciclina e ceftriaxone come linea terapeutica se somministrati per più di due settimane consecutive e Rituximab somministrato in vena per almeno 3 dosi) -consenso informato scritto firmato
    E.4Principal exclusion criteria
    -Conventional cancer treatments (chemotherapy, radiotherapy, immunotherapy), experimental (antibiotics) or concomitant corticosteroid. -Allergy-Systemic symptoms known to rituximab -Pregnancy or nursing being -Co-diagnosis of pemphigus -Postsurgical conjunctival scarring that may interfere with the administration and evaluation of treatment response (second clinical opinion of a specialist eye doctor) -Diagnosis of other cancers malignancy in the previous 5 years (except basal cell skin squamous cell carcinomas in situ of the skin or cervix)-Presence of any physical or psychological that constraints the patient compliance
    -Trattamenti oncologici convenzionali (chemioterapia, radioterapia, immunoterapia), sperimentali (antibiotici) o corticosteroidei concomitanti. -Allergia nota a rituximab -Sintomi sistemici -Gravidanza/allattamento in corso -Diagnosi concomitante di pemfigo -Esiti cicatriziali congiuntivali postchirurgici che possano interferire con la somministrazione del trattamento e la valutazione della risposta (secondo parere clinico dello specialista oculista) -Diagnosi di altre neoplasie maligne nei 5 anni precedenti (esclusi basalioma cutaneo, carcinomi spinocellulari in situ della cute o della cervice uterina) -Presenza di ogni condizione fisica o psichica che vincoli la compliance del paziente
    E.5 End points
    E.5.1Primary end point(s)
    safety of intralesional rituximab, defined by the incidence of adverse events can > or equal to 4 (NCI CTCAE V.4.3) during the experimental treatment.
    -sicurezza del rituximab intralesionale, definite dall’incidenza d’eventi avversi grado > o uguake a 4 (NCI CTCAE v.4.3) durante il trattamento sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during treatment and during the entire follow-up
    durante il trattamento e per tutto il follow up
    E.5.2Secondary end point(s)
    -Activities of intralesional rituximab (overall response, complete response and duration of response). -Activities of intralesional rituximab in patients with indolent CD20 + conjunctival refractory to previous treatment with systemic rituximab. -Response rate and duration of response with the addition of rituximab to autologous serum in patients unresponsive to rituximab alone.
    -Attività del rituximab intralesionale (risposte globali, risposte complete e durata della risposta). -Attività del rituximab intralesionale in pazienti affetti da linfoma indolente CD20+ della congiuntiva refrattario a trattamenti precedenti con rituximab sistemico. -Tasso di risposte e durata della risposta con l’aggiunta del siero autologo al rituximab, nei pazienti non responsivi al solo rituximab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from the start of the study until the eventual progression
    dall'avvio dello studio fino ad eventuale progressione
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    periodic monitoring until the eventual progression
    controlli periodici fino ad eventuale progressione
    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 Decision2011-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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