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    Summary
    EudraCT Number:2012-000735-27
    Sponsor's Protocol Code Number:FIL_SGN01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-20
    Trial results View 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 number2012-000735-27
    A.3Full title of the trial
    A phase II study of SGN-35 (brentuximab vedotin) of patients with relapsed or refractory Primary mediastinal large B-cell lymphoma (PMLBCL).
    Studio di fase II con SGN-35 (Brentuximab vedotin) nei pazienti affetti da Linfoma a grandi cellule B primitivo del mediastino recidivante o refrattario (PMLBCL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of SGN-35 (brentuximab vedotin) of patients with relapsed or refractory Primary mediastinal large B-cell lymphoma (PMLBCL).
    Studio di fase II con SGN-35 (Brentuximab vedotin) nei pazienti affetti da Linfoma a grandi cellule B primitivo del mediastino recidivante o refrattario (PMLBCL)
    A.4.1Sponsor's protocol code numberFIL_SGN01
    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 ITALIANA LINFOMI ONLUS
    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 supportMillennium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    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 pointSecretary
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia, 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390131206132
    B.5.5Fax number00390131263455
    B.5.6E-mailsegreteria@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 Brentuximab Vedotin
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Global Research and Development Centre (Europe) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameBrentuximab Vedotin
    D.3.2Product code NA
    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.3.11 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) 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
    Relapsed or refractory Primary mediastinal large B-cell lymphoma (PMLBCL)
    Linfoma a grandi cellule B primitivo del mediastino recidivante o refrattario (PMLBCL)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory Primary mediastinal large B-cell lymphoma (PMLBCL)
    Linfoma a grandi cellule B primitivo del mediastino recidivante o refrattario (PMLBCL).
    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
    To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
    Stabilire l’efficacia antitumorale del Brentuximab vedotin come agente singolo (1.8 mg/kg somministrato per via endovenosa ogni 3 settimane) misurata in base alla risposta obiettiva complessiva nei pazienti affetti da linfoma a grandi cellule B primitivo del mediastino recidivato o refrattario.
    E.2.2Secondary objectives of the trial
    • To assess duration of tumor control, including duration of response and progression-free survival
    • To assess survival
    • To assess the safety and tolerability of Brentuximab vedotin
    • Valutare la durata del controllo tumorale, compresa la durata della risposta e la sopravvivenza libera da progressione
    • Valutare la sopravvivenza
    • Valutare la sicurezza e la tollerabilità di Brentuximab vedotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for this study:
    1) Patients with relapsed or refractory PMLBCL who have previously received at least 1 line of treatment. Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of Brentuximab vedotin.
    2) Histologically-confirmed CD30-positive disease.
    3) Age greater than or equal to 18 years.
    4) Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
    5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6) The following required baseline laboratory data: absolute neutrophil count (ANC) ≥1500/μL, unless known marrow involvement due to disease, platelets ≥75,000/μL, unless known marrow involvement due to disease, bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilbert’s disease, serum creatinine ≤1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN.
    7) Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of Brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
    8) Both females of childbearing potential and males who have partners of childbearing potential must agree to use two effective contraceptive methods during the study and for 30 days following the last dose of study drug.
    9) Male patients, even if surgically sterilized (i.e., post vasectomy), who:
    • Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of the study drug, or
    • Agree to completely abstain from heterosexual intercourse
    10) Patients or their legally authorized representative must provide written informed consent.
    I pazienti devono presentare tutti i seguenti criteri di inclusione per essere arruolati in questo studio:
    1. Pazienti affetti da linfoma PMLBCL recidivato o refrattario che hanno ricevuto in precedenza almeno 1 linea di trattamento. I pazienti devono aver completato qualsiasi precedente trattamento con radiazioni, chemioterapia, farmaci di origine biologica, immunoterapici e/o altri farmaci sperimentali almeno 4 settimane prima della prima somministrazione di Brentuximab vedotin.
    2. Malattia CD-30 positiva confermata con diagnosi istologica.
    3. Età maggiore o uguale a 18 anni.
    4. Malattia con elevato livello di captazione del fluorodeossiglucosio (FDG) e una lesione misurabile di almeno 1.5 cm come documentato dagli esami PET e TC spirale.
    5. Un Eastern Cooperative Oncology Group (ECOG) performance status di 0 o 1.
    6. La soddisfazione dei seguenti criteri al baseline inerenti dati di laboratorio: conta assoluta dei neutrofili (ANC) ≥1500/μL salvo noto coinvolgimento del midollo dovuto alla malattia, piastrine ≥75,000/μL salvo noto coinvolgimento del midollo dovuto alla malattia, bilirubina ≤1.5X limite superiore della norma (ULN) or ≤3X ULN per pazienti con malattia di Gilbert, creatinina ≤1.5X ULN, alanina aminotransferasi (ALT) and aspartato aminotransferasi (AST) ≤2.5X ULN.
    7. Le donne in età fertile devono avere un risultato negativo al test di gravidanza su siero o urina con β-hCG nei 7 giorni precedenti la prima somministrazione di Brentuximab vedotin. Le donne non potenzialmente fertili sono quelle in fase di post-menopausa da più di un anno o che hanno avuto una legatura bilaterale delle tube o isterectomia.
    8. Uomini e donne in età fertile che hanno partner in età fertile devono acconsentire all’uso di due metodi contraccettivi efficaci durante il corso dello studio e per 30 giorni successivi all’ultima somministrazione del farmaco dello studio.
    9. I pazienti di sesso maschile, anche se chirurgicamente sterilizzati (es. post-vasectomia), che:
    • Concordino nell’utilizzare una barriera contraccettiva efficace durante l’intero periodo di trattamento e nei 6 mesi successivi all’ultima somministrazione del farmaco dello studio, o
    • Concordino alla completa astinenza da rapporti eterosessuali.
    10. I pazienti o i loro rappresentanti legali autorizzati devono fornire il loro consenso informato scritto.
    E.4Principal exclusion criteria
    If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for study:
    1) Previous treatment with Brentuximab vedotin.
    2) Previously received an allogeneic transplant.
    3) Congestive heart failure, Class III or IV, by the NYHA criteria.
    4) History of another primary malignancy for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
    5) Known cerebral/meningeal disease.
    6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
    7) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of Brentuximab vedotin.
    8) Current therapy with other systemic anti-neoplastic or investigational agents.
    9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of Brentuximab vedotin.
    10) Women who are pregnant or lactating and breastfeeding.
    11) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
    12) Known human immunodeficiency virus (HIV) positive.
    13) Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
    14) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
    Se il paziente presenta almeno uno dei seguenti criteri di esclusione non sarà arruolato in questo studio:
    1. Pazienti precedentemente trattati con Brentuximab vedotin.
    2. Pazienti che hanno ricevuto trapianto allogenico.
    3. Insufficienza cardiaca congestizia, di Classe III o IV, secondo i criteri NYHA.
    4. Precedente storia di altro tumore maligno primario che non è andato in remissione da almeno 3 anni (sono esenti dal limite dei 3 anni i seguenti casi: le neoplasia cutanee diverse dal melanoma, trattamento per la cura localizzata del tumore della prostata e carcinoma della cervice in situ alla biopsia o lesione intraepiteliale squamosa al PAP-TEST).
    5. Nota malattia cerebrale/meningea.
    6. Segni o sintomi di Leucoencefalopatia multifocale (PML)
    7. Qualunque infezione attiva virale, batterica o fungina richiedente terapia antimicrobica nelle 2 settimane precedenti la prima somministrazione di Brentuximab vedotin.
    8. Terapie in atto con altri anti-neoplastici sistemici o farmaci sperimentali.
    9. Terapia con corticosteroidi a dosi maggiori o uguali a 20 mg/giorno di prednisone o equivalenti nella settimana precedente la prima somministrazione di Brentuximab vedotin.
    10. Donne in gravidanza o in allattamento.
    11. Pazienti con nota ipersensibilità alle proteine ricombinate, alle proteine murine o ad un qualsiasi eccipiente contenuto nella formulazione farmacologica.
    12. Nota positività al virus dell’HIV (Human Immunodeficiency Virus).
    13. Nota positività all’antigene di superficie dell’Epatite B, o nota o sospetta infezione da virus dell’Epatite C attiva.
    14. Pazienti con una demenza o un alterato stato mentale che precluderebbe la reale comprensione e rilascio del consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Overall objective response rate (ORR).
    Tasso di risposta globale (ORR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    • Duration of response
    • Complete remission (CR) rate
    • Progression-free survival (PFS)
    • Overall survival (OS)
    • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
    Additional endpoints are:
    • Event-free survival (EFS)
    • B symptom resolution rate
    Gli endpoint secondari sono i seguenti:
    • Durata della risposta
    • Tasso di Remissione completa (CR)
    • Sopravvivenza libera da progressione (PFS)
    • Sopravvivenza complessiva (OS)
    • Tipo, incidenza, importanza, gravità, e grado di relazione degli eventi avversi e delle anomalie rilevate dagli esami di laboratorio

    Endpoint aggiuntivi:
    • Sopravvivenza libera da eventi (EFS)
    • Grado di risoluzione dei sintomi B
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    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.8.3 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 concerned11
    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.
    Ultima visita ultimo paziente arruolato.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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) Yes
    F.1.2.1Number of subjects for this age range: 15
    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 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)
    Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.
    Gli esami di follow-up a lungo termine (compresi i dati sulla sopravvivenza e sullo stato della malattia) saranno eseguiti ogni 12 settimane fino alla chiusura dello studio o al decesso del paziente, qualsiasi evento si verifichi prima. I pazienti che interromperanno il farmaco presentando una malattia stabile o responsiva saranno sottoposti ad esami TC ogni 12 settimane fino a progressione di malattia.
    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 Decision2013-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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.

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