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    EudraCT Number:2013-004109-24
    Sponsor's Protocol Code Number:FIL_BVHD01
    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:2014-03-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004109-24
    A.3Full title of the trial
    A phase II study of Brentuximab Vedotin (BV) in the treatment of elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease
    Studio di fase II con l’utilizzo di Brentuximab Vedotin (BV) nel trattamento di pazienti con Linfoma di Hodgkin (HL) in prima recidiva o resistenti alla terapia di prima linea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of Brentuximab Vedotin (BV) in the treatment of elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease
    Studio di fase II con l’utilizzo di Brentuximab Vedotin (BV) nel trattamento di pazienti con Linfoma di Hodgkin (HL) in prima recidiva o resistenti alla terapia di prima linea
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberFIL_BVHD01
    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.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.5.4Telephone number00390131206294
    B.5.5Fax number00390131263455
    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. name Brentuximab Vedotin
    D. of the Marketing Authorisation holderTakeda Global Research and development center (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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease
    Pazienti anziani con linfoma di Hodgkin (HL) alla prima recidiva o refrattari alla prima linea di terapia
    E.1.1.1Medical condition in easily understood language
    elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease
    Pazienti anziani con linfoma di Hodgkin (HL) alla prima recidiva o refrattari alla prima 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
    To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
    Determinare l’efficacia antitumorale del brentuximab vedotin (BV) (somministrato endovena alla dose di 1.8 mg/kg ogni 3 settimane) misurata mediante il tasso obbiettivo di risposte globali nei pazienti anziani con linfoma di Hodgkin in prima recidiva o resistenti alla terapia di prima linea.
    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 BV
    • To assess disease-related symptoms
    • Valutare la durata del controllo del tumore, compreso la durata della risposta e la sopravvivenza libera da progressione
    • Valutare la sopravvivenza
    • Valutare la sicurezza e tollerabilità del BV
    • Valutare i sintomi correlate alla malattia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically confirmed CD30-positive disease 2) Elderly patients at first relapse or with primary refractory HL (i.e. patients who have previously received only 1 line of treatment. 3) Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents greater than 5 half-lives of the last dose of that prior treatment prior to the first dose of BV and must have fully recovered from the acute toxic effects prior to entering this study. 4) Age greater than or equal to 60 years. 5) Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT. 6) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7) 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. 8) Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result 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. 9) Females of childbearing potential must agree to use two effective contraceptive methods during the study and for 6 months following the last dose of study drug or agree to completely abstain from heterosexual intercourse. 10) Males, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse. 11) Patients must provide written informed consent.
    1) Conferma istologica di malattia tramite la positività del marcatore CD30 2) Pazienti anziani in prima recidiva o resistenti alla terapia di prima linea di terapia per il linfoma di Hodgkin 3) Pazienti che devono aver completato un precedente trattamento con radioterapia, chemioterapia, farmaci biologici, immunoterapia e/o con altri agenti sperimentali di cui devono aver smaltito un quantitativo superiore a 5 emivite dell’ultima dose acquisita prima dell’ iniziale somministrazione di BV; inoltre devono aver smaltito completamente gli effetti tossici acuti prima di entrare in questo studio. 4) Età ≥ 60 anni. 5) Pazienti che abbiano malattia confermata tramite Fluorodeoxyglucosio (FDG) e misurabile di almeno 1.5 cm e documentata sia dalla PET che dalla CT spirale. 6) Un ECOG (Eastern Cooperative Oncology Group) performance status di 0 o 1. 7) Sono richiesti inoltre i seguenti dati di laboratorio: neutrofili assoluti (ANC) ≥1500/μL, a meno che non ci sia un coinvolgimento noto del midollo dovuto alla malattia, piastrine ≥75,000/μL, a meno che non ci sia un coinvolgimento noto del midollo dovuto alla malattia, bilirubina ≤1.5 volte superiore al limite normale (ULN) o ≤3 X ULN per pazienti con malattia di Gilbert, creatinina serica ≤1.5 X ULN, alanina amminotrasferasi (ALT) e aspartato aminotransferasi (AST) ≤2.5 X ULN. 8) Le donne in età fertile dovranno effettuare un test di gravidanza che dovrà risultare β-HCG negativo (il test dovrà essere effettuato allo screening e al giorno 1 del ciclo 1 prima della somministrazione di Brentuximab vedotin). Donne non potenzialmente fertili o in menopausa da almeno 1 anno prima della visita di screening o rese chirurgicamente sterili tramite isterectomia o il legame bilaterale delle tube. 9) Donne in età fertile che si impegnano a utilizzare almeno 2 metodi contraccettivi considerati efficaci dalla firma del consenso informato fino a 6 mesi dopo l’ultima somministrazione del farmaco in studio o donne che si impegnano ad astenersi completamente dai rapporti eterosessuali. 10) Pazienti di sesso maschile, anche se resi chirurgicamente sterili (stato di post vasectomia) che si impegnano a utilizzare un efficace contraccettivo a barrier durante tutta la durata dello studio e fino a 6 mesi dopo l’ultima somministrazione del farmaco in studio o pazienti di sesso maschile che si impegnano ad astenersi completamente da rapporto eterosessuali. 11) Pazienti che hanno firmato il consenso informato.
    E.4Principal exclusion criteria
    1) Previous treatment with BV 2) Peripheral neuropathy > grade 1. 3) Known history of any of the following cardiovascular conditions: a. Myocardial infarction within 2 years of study entry. b. Congestive heart failure, Class III or IV, by the NYHA criteria. c. Evidence of current uncontrolled cardiac arrhythmias, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. d. Recent evidence (within 6 months of study entry) of a left ventricular ejection fraction <50% 4) History of another primary malignancy for within 3 years of study entry. (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 BV. 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 BV. 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 of brentuximab vedotin. 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.
    1) Precedente trattamento con BV 2) Neuropatia periferica di grado > 1. 3) Pazienti con anamnesi di una qualsiasi delle seguenti condizioni cardiovascolari: a. Infarto del miocardio entro 2 anni. b. Insufficienza cardiaca di classe III o IV secondo la classificazione New York Heart Association (NYHA). c. Evidenza di condizioni cardiovascolari non controllate incluse aritmie cardiache, insufficienza cardiaca congestizia (CHF), angina, o evidenza elettrocardiografica di ischemia acuta o anomalie attive del sistema di conduzione. d. Recenti evidenze (entro 6 mesi dalla somministrazione della prima dose del farmaco in studio) di una frazione di eiezione ventricolare sinistra <50%. 4) Altra neoplasia diagnosticata o trattata nei 3 anni precedenti l’inizio della terapia o neoplasia diagnosticata in precedenza con evidenza di malattia residua. Non vengono esclusi i pazienti con tumori della pelle (non melanoma), carcinoma della prostata localizzato trattato per la cura e carcinoma della cervice in situ sottoposti a resezione completa o carcinoma squamoso intraepiteliale valutato con il PAP test. 5) I pazienti con nota malattia cerebrale / meningea. 6) I pazienti con segni o sintomi di leucoencefalopatia multifocale progressiva (PML). 7) Pazienti con infezione virale, batterica o fungina attiva che richiede un trattamento con terapia antibiotica entro 2 settimane precedenti alla prima dose di Brentuximab vedotin. 8) I pazienti che stanno facendo terapia con agenti sistemici antineoplastici o altri agenti sperimentali. 9) Pazienti che hanno fatto terapia con corticosteroidi in misura ≥ 20 mg/die (per esempio prednisone) entro una settimana prima dell’inizio della terapia con BV. 10) Donne in gravidanza o allattamento 11) Pazienti con nota ipersensibilità alle proteine ricombinate, alle proteine murine o ad un qualsiasi eccipiente contenuto nella formulazione farmacologica. del brentuximab vedotin. 12) Pazienti HIV positivi. 13) Epatite B nota HBsAg + o sospetta infezione da 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)
    The primary endpoint of this study is the overall objective response rate (ORR).
    L’endpoint primario di questo studio è il tasso di risposta globale (ORR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR will be evaluated at the end of the treatment (from 8 to 16 cycles).
    Il tasso di Risposte verrà valutato al termine dei cicli di terapia (da 8 a 16).
    E.5.2Secondary end point(s)
    • Duration of response
    • Complete remission (CR) rate
    • Progression-free survival (PFS) at one years
    • Overall survival (OS) at one years
    • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
    • Event-free survival (EFS) at one years
    • B symptom resolution rate
    Tasso di Remissione completa (CR)
    Sopravvivenza libera da progressione (PFS) a un anno
    Sopravvivenza complessiva (OS) a un anno
    Tipo, incidenza, importanza, gravità, e grado di relazione degli eventi avversi e delle anomalie rilevate dagli esami di laboratorio
    Sopravvivenza libera da eventi (EFS)
    Grado di risoluzione dei sintomi B
    E.5.2.1Timepoint(s) of evaluation of this end point
    Complete response rate at the end of the treatment (from 8 to 16 cycles). The others end point will be evaluated at the end of follow up (after 42 months to the first enrollment)
    Il tasso di Risposte complete verrà valutato al termine dei cicli di terapia (da 8 a 16). Gli altri end point saranno valutati al termine dei due anni di follow up.
    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. 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.8.3 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 concerned5
    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
    Ultima visita ultimo paziente arruolato
    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 months6
    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: 20
    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 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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
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