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    EudraCT Number:2013-003934-33
    Sponsor's Protocol Code Number:FIL_BRidge
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003934-33
    A.3Full title of the trial
    A pilot phase II study with BRENTUXIMAB VEDOTIN as pre-ASCT induction therapy in relapsed/refractory Hodgkin’s lymphoma patients non responding to IGEV salvage treatment.
    Studio pilota di fase II con BRENTUXIMAB VEDOTIN come terapia di induzione pre-ASCT in pazienti affetti da Linfoma di Hodgkin recidivato o refrattario non rispondenti alla terapia di salvataggio con IGEV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot phase II study with BRENTUXIMAB VEDOTIN as pre-ASCT induction therapy in relapsed/refractory Hodgkin’s lymphoma patients non responding to IGEV salvage treatment.
    Studio pilota di fase II con BRENTUXIMAB VEDOTIN come terapia di induzione pre-ASCT in pazienti affetti da Linfoma di Hodgkin recidivato o refrattario non rispondenti alla terapia di salvataggio con IGEV.
    A.4.1Sponsor's protocol code numberFIL_BRidge
    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 pointSecretariat
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.4Telephone number00390131206129
    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 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. 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
    Hodgkin’s Lymphoma
    Linfoma di Hodgkin
    E.1.1.1Medical condition in easily understood language
    Hodgkin’s Lymphoma
    Linfoma di Hodgkin
    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 17.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the activity of brentuximab vedotin in terms of complete remission (CT scan and FDG-PET negative) in patients with relapsed/refractory Hodgkin’s Lymphoma not responding (FDG-PET positive) to salvage treatment with IGEV.
    Valutare l'attività di brentuximab vedotin in termini di remissione completa (TC scan e FDG-PET negativa) in pazienti affetti da Linfoma di Hodgkin recidivato o refrattario non rispondenti (FDG-PET positiva) alla terapia di salvataggio con IGEV.
    E.2.2Secondary objectives of the trial
    To evaluate if brentuximab vedotin administration after unsatisfactory response to IGEV is able to achieve CR, thus improving progression free survival (PFS) and duration of remission.

    To evaluate the toxicity of brentuximab vedotin in terms of haematological and extra-haematological side effects according to the NCI CTCAE (Version 4.03).

    Valutare se la somministrazione di brentuximab vedotin dopo la risposta insoddisfacente a IGEV è in grado di raggiungere una risposta completa (RC), migliorando così la sopravvivenza libera da progressione (PFS) e la durata della remissione.
    Valutare la tossicità di brentuximab vedotin in termini di effetti collaterali ematologici ed extra-ematologiche secondo il NCI CTCAE (versione 4.03).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Classical Hodgkin Lymphoma according to the World Health
    Organisation (WHO) classification
    2. Histologically confirmed CD30+ HL at diagnosis
    3. Patients at the first line salvage therapy
    4. FDG-PET positivity after two cycles of IGEV treatment
    5. PBPCs should have been collected after the first or the second IGEV
    6. Age≥ 18 years
    7. ECOG performance status of 0-2
    8. Life expectancy > 6 months.
    9. Written informed consent was obtained from the patient prior to any
    study-specific screening procedures
    10. Patients must be available for periodic blood sampling, study-related
    assessments and management of toxicity at the treating institution
    11. Females of childbearing potential must have a negative β-HCG
    pregnancy test result (pregnancy test should be performed at
    screening an on day 1 of cycle 1 prior to brentuximab vedotin
    12. Female patient is either post-menopausal for at least 1 year before
    the screening visit or surgically sterile or if of childbearing potential,
    agree to practice 2 effective methods of contraception, at the same
    time, from the time of signing the informed consent through 6 months
    after the last dose of study drug, or agrees to completely abstain
    from heterosexual intercourse.

    13. Male patients, even if surgically sterilized, (i.e., status post
    vasectomy) agree to practice effective barrier contraception during
    the entire study period and through 6 months after the last dose of
    study drug, or agrees to completely abstain from heterosexual
    14. Required baseline laboratory data:
    - Absolute neutrophil count ≥ 1500/µl
    - Platelet count ≥ 75.000/ µl
    - Haemoglobin must be ≥ 8 g/dL
    - Serum bilirubin ≤ 1.5 times ULN
    - Serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
    - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
    1. Linfoma di Hodgkin a istologia classica secondo la classificazione WHO.
    2. Histologically confirmed CD30+ HL at diagnosis
    3. Pazienti alla prima linea di terapia di salvataggio.
    4. FDG-PET positive dopo 2 cicli di trattamento con IGEV
    5. PBPCs raccolte dopo il primo o il secondo ciclo di IGEV.
    6. Età ≥ 18
    7. ECOG performance status 0-2
    8. Aspettativa di vita > 6 mesi
    9. Firma del consenso informato prima di effettuare le procedure di screening studio specifiche.
    10. I pazienti dovranno essere disponibili per i periodici prelievi di sangue, la valutazione e la gestione della tossicità presso l’ospedale che li ha in cura.
    11. 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.
    12. Donne in menopausa da almeno 1 anno prima della visita di screening o rese chirurgicamente sterili o 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.
    13. 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.
    14. Al baseline richiesti i seguenti valori di laboratorio:
    - Conta assoluta dei neutrofili ≥ 1500/µl
    - Conta piastrinica ≥ 75.000/ µl
    - Emoglobina ≥ 8 g/dL
    - Bilirubina sierica ≤ 1.5 times ULN
    - Creatinine < 2.0 mg/dL e/o creatinine clearance o creatinine clearance calcolata > 40 mL/minute.
    - ALT e AST ≤ 2.5 times ULN
    E.4Principal exclusion criteria
    1. Peripheral neuropathy > Grade 1
    2. Histologic diagnosis different from Hodgkin Lymphoma
    3. First line treatment with BEACOPP
    4. Compressive symptoms caused by the presence of Lymphoma
    5. Patients who have been treated previously with any anti-CD30
    6. Known hypersensitivity to any recombinant proteins, murine proteins,
    or excipients contained in the brentuximab vedotin formulation.
    7. Known human immunodeficiency virus (HIV) positive
    8. Known hepatitis B surface antigen-positive, or known or suspected
    active hepatitis C infection
    9. Diagnosed or treated for another malignancy within 3 years before
    the first dose or previously diagnosed with another malignancy and
    have evidence of residual disease. Patients with nonmelanoma skin
    cancer or carcinoma in situ of any type are not excluded if they have
    undergone complete resection.
    10. Patients with known history of any of the following cardiovascular
    conditions :
    • Myocardial infarction within 2 years of randomization
    • New York Heart Association (NYHA) Class III or IV heart failure
    (see Appendix E)
    • Evidence of current uncontrolled cardiovascular conditions,
    including cardiac arrhythmias, congestive heart failure (CHF),
    angina, or electrocardiographic evidence of acute ischemia or
    active conduction system abnormalities
    • Recent evidence (within 6 months before first dose of study drug)
    of a left-ventricular ejection fraction <50%
    11. Patients with known active viral, bacterial, or fungal infection
    requiring treatment with antimicrobial therapy within 2 weeks prior to
    the first dose of brentuximab vedotin.
    12. Patients with known active Grade 3 or higher viral, bacterial, or
    fungal infection within 2 weeks prior to the first dose of brentuximab
    13. Patients with known cerebral/meningeal disease (HL or any other
    etiology), including signs or symptoms of Progressive Multifocal
    Leukoencephalopathy (PML).
    14. Any serious medical or psychiatric illness that could, in the
    investigator's opinion, potentially interfere with the completion of
    treatment according to protocol.
    15. Symptomatic neurologic disease compromising normal activities of
    daily living or requiring medications.
    16. Patients who are pregnant, or lactating and breastfeeding.
    17. Patients that have not completed any prior treatment chemotherapy
    and/or other investigational agents within at least 5 half-lives of last
    dose of that prior treatment.
    1. Neuropatia periferica > grado 1
    2. Diagnosi istologica diversa da Linfoma di Hodgkin
    3. Prima linea di trattamento con BEACOPP
    4. Sintomi da compressione causati dalla presenza del linfoma
    5. Pazienti trattati precedentemente con anticorpo anti-CD30
    6. Nota ipersensibilità a qualsiasi proteina ricombinante, proteine murine, o eccipienti contenuti nella formulazione di Brentuximab vedotin.
    7. Pazienti HIV positivi
    8. Epatite B nota HBsAg + o sospetta infezione da epatite C attiva.
    9. 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) o carcinoma in situ sottoposti a resezione completa.
    10. Pazienti con anamnesi di una qualsiasi delle seguenti condizioni cardiovascolari:
    - Infarto del miocardio entro 2 anni
    - Insufficienza cardiac di classe III o IV secondo la classificazione New York Heart Association (NYHA) (see Appendix E)
    - 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.
    - Recenti evidenze (entro 6 mesi dalla somministrazione della prima dose del farmaco in studio) di una frazione di eiezione ventricolare sinistra <50%.
    11. 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.
    12. I pazienti infezione attiva virale, batterica o fungina di grado superiore o uguale a 3 entro 2 settimane precedenti alla prima dose di Brentuximab vedotin.
    13. I pazienti con nota malattia cerebrale / meningea (HL o qualsiasi altra eziologia), compresi i segni o i sintomi di leucoencefalopatia multifocale progressiva (PML).
    14. Qualsiasi grave malattia medica o psichiatrica che potrebbe, a giudizio dello sperimentatore, potenzialmente interferire con il completamento del trattamento secondo il protocollo.
    15. Malattia neurologica sintomatica che compromette le normali attività della vita quotidiana o che richiede l’utilizzo di farmaci.
    16. Pazienti in gravidanza o in fase di allattamento
    17. Pazienti che non hanno completato qualsiasi trattamento chemioterapico precedente e/o altra terapia sperimentale da almeno 5 volte l’emivita dell’ultima dose di tale trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    CR rate
    Tasso di RC
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year and half from the beginning of the study
    1 anno e mezzo dall’inizio dello studio
    E.5.2Secondary end point(s)
    Toxicity and PFS
    Tossicità e PFS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity: 1 year and half from the beginning of the study
    PFS: 2 years and half from the beginning of the study
    La tossicità va pari alla risposta (valutazione finale dello studio dopo 1 anno e mezzo dall’'inizio dello studio). PFS dopo circa 2.5 anni dall’inizio dello studio.
    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 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 concerned7
    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
    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 months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state13
    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)
    Common clinical practise
    Comune pratica clinica
    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 Decision2014-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
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