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    Summary
    EudraCT Number:2013-003946-17
    Sponsor's Protocol Code Number:FIL_PTCL_BV
    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:2014-09-23
    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 number2013-003946-17
    A.3Full title of the trial
    Phase II study on the role of brentuximab vedotin as single agent in the treatment of relapsed/refractory CD30 positive peripheral T cell lymphoma (PTCL) patients
    Studio di fase 2 sul ruolo di brentuximab vedotin come singolo agente nel trattamento dei pazienti affetti da linfoma a cellule T periferiche ricaduto/refrattario CD30 positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study on the role of brentuximab vedotin as single agent in the treatment of relapsed/refractory CD30 positive peripheral T cell lymphoma (PTCL) patients
    Studio di fase 2 sul ruolo di brentuximab vedotin come singolo agente nel trattamento dei pazienti affetti da linfoma a cellule T periferiche ricaduto/refrattario CD30 positivo
    A.4.1Sponsor's protocol code numberFIL_PTCL_BV
    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., The Takeda Oncology Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSegreteria Fondazione Italiana Linfomi Onlus
    B.5.2Functional name of contact pointSegreteria FIL
    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 number00390131206071
    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.3.4Pharmaceutical form Infusion
    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 INNBrentuximab Vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameSGN-35
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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/REFRACTORY CD30 POSITIVE PERIPHERAL T CELL LYMPHOMA (PTCL)
    linfoma a cellule T periferiche ricaduti/refrattari CD30 positivi
    E.1.1.1Medical condition in easily understood language
    PTCL CD30+
    PTCL CD30+
    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 refractory/relapsed peripheral T-cell lymphoma (PTCL) patients.
    Determinare l’efficacia antitumorale del singolo agente brentuximab vedotin (BV) (somministrato per via endovenosa ogni 3 settimane alla dose di 1.8 mg/kg) valutandola tramite il tasso di risposta oggettiva globale nei pazienti affetti da linfoma a cellule T periferiche ricaduto/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 BV
    • To assess correlation between CD30 expression and response
    • Valutare la durata del controllo tumorale, comprese la durata della risposta e la sopravvivenza libera da malattia.
    • Valutare la sopravvivenza
    • Valutare la sicurezza e la tollerabilità di BV
    • Valutare la correlazione tra espressione di CD30 e la risposta alla terapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent.
    2. Males and females ≥18 years at the time of enrolment.
    3. Histologically confirmed diagnosis of PTCL (PTCL-not otherwise specified [PTCL-NOS], angioimmunoblastic T cell lymphoma [AILT] and transformed mycosis fungoides) according to World Health Organization (2008) classification.
    4. Histologically confirmed CD30+ PTCL.
    5. Availability of histological material for central review and pathobiological studies.
    6. Failed or intolerant of at least one prior systemic antilymphoma therapy.
    7. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry.
    8. At least one site of disease measurable in two dimensions by computed tomography. Both nodal and extranodal disease will be considered (lymphnodes must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm).
    9. Hematology values within the following limits:
    o Absolute neutrophil count (ANC) ≥ 1500/mm3 independent of growth factor support.
    o Platelets ≥75,000/mm3 or ≥50,000/mm3 if bone marrow involvement is independent of transfusion support.
    o Hemoglobin level ≥8 g/dL.
    10. Biochemical values within the following limits:
    o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN).
    o Total bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin).
    o Serum creatinine ≤ 2 x ULN.
    o Serum albumin ≥ 3 g/dL.
    11. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
    12. WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
    13. Male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
    1. Consenso informato scritto firmato.
    2. Maschio/femmina di età ≥18 anni all’arruolamento.
    3. Diagnosi confermata istologicamente di PTCL (PTCL nos, non altrimenti specificato, linfoma T angioimmunoblastico e micosi fungoide trasformata) in accordo con la classificazione WHO 2008.
    4. PTCL confermato istologicamente come CD30 positivo.
    5. Disponibilità di materiale istologico per la revisione centralizzata e per studi patobiologici.
    6. Ricaduto o refrattario dopo almeno una terapia sistemica antilinfoma.
    7. Performance status ECOG ≤ 1 all’arruolamento.
    8. Almeno un sito di malattia misurabile bidimensionalmente tramite esame di tomografia computerizzata assiale (TAC). Verrà presa in considerazione sia malattia nodale sia extranodale (i linfonodi devono avere l’asse maggiore di 1.5 indipendentemente dalla lunghezza dell’asse minore oppure l’asse maggiore di una lunghezza compresa tra 1.1 e 1.5 cm e il minore >1.0 cm).
    9. I valori ematologici devono essere nei seguenti limiti:
    o Conta assoluta dei neutrofili ≥ 1500 /mm3 senza supporto di fattori di crescita;
    o Piastrine ≥ 75,000/mm3 o ≥ 50,000/mm3 se il coinvolgimento midollare è
    indipendente dal supporto trasfusionale;
    o Emoglobina ≥ 8 gr/dL.
    10. I valori biochimici devono essere nei seguenti limiti:
    o Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤3 ULN;
    o Bilirubina totale ≤ 1.5 x ULN a meno che l’aumento di bilirubina non sia dovuta
    alla sindrome di Gilbert o comunque di origine non epatica);
    o Cretinina sierica ≤ 2 x ULN;
    o Albumina sierica ≥ 3 gr/dL.
    11. Le donne fertili devono avere un test di gravidanza negativo entro la settimana precedente la prima infusione di BV.
    12. Le donne fertili devono accettare di utilizzare un contraccettivo efficace definito come contraccettivo orale, metodo di doppia barriera o praticare astinenza da rapporti sessuali durante lo studio e per 6mesi dopo l’ultima dose di BV.
    13. I soggetti maschili e le loro compagne fertili devono accettare di utilizzare un appropriato metodo contraccettivo o praticare l’astinenza da rapporti sessuali durante lo studio e per 6 mesi dopo l’ultima dose di BV.
    E.4Principal exclusion criteria
    1. Diagnosis of CTCL, ALCL, mycosis fungoides or Sezary Syndrome.
    2. CD30 expression < 10 % as measured by IHC
    3. 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.
    4. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
    5. Any serious active disease or co-morbid medical condition (according to investigator's decision).
    6. Prior history of malignancies other than lymphoma (except for a history of a complete resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years.
    7. Pre-existing peripheral neuropathy Grade ≥2.
    8. Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
    9. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    10. Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study or a positive pregnancy test on Day 1 before first dose of study drug.

    11. CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
    12. History of clinically relevant liver or renal insufficiency; significant pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances.
    13. Known history of any of the following cardiovascular conditions
    o Myocardial infarction within 2 years from enrollment
    o New York Heart Association (NYHA) Class III or IV heart failure
    o 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
    o Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%

    14. Active opportunistic infection.
    15. Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active infection with Hepatitis B.
    16. Prior allogeneic stem cell transplant.
    1. Diagnosi di CTCL, ALCL, micosi fungoide o sindrome di Sezary;
    2. Espressione di CD30 <10% misurati secondo i criteri IHC;
    3. Pazienti che hanno completato trattamenti preventivi con chemioterapia e/o con altri agenti sperimentali per cui non siano trascorse almeno 5 emivite dall’ultima dose di tale trattamento preliminare.
    4. Nota ipersensibilità alle proteine ricombinanti, alle proteine murine o a qualunque altro eccipiente contenuto nella formulazione farmacologica del brentuximab vedotin
    5. Qualsiasi malattia o co-morbidità attiva seria (a discrezione dello Sperimentatore).
    6. Precedente storia di neoplasie diverse dal linfoma (ad eccezione di carcinoma basocellulare o squamoso della cute o carcinoma in situ della cervice o della mammella) a meno che il soggetto non sia indenne da questa malattia da almeno 3 anni.
    7. Neuropatia periferica preesistente di grado ≥2.
    8. Segni o sintomi di leucoencefalopatia multifocale progressiva (PML).
    9. Pazienti con una demenza o un alterato stato mentale o condizione medica che precluderebbe la reale comprensione e rilascio del consenso informato.
    10. Donne in gravidanza o in allattamento o uomini e donne potenzialmente fertili che non sono disposti ad utilizzare un metodo adeguato di controllo delle nascite per tutta la durata dello studio o donne il cui test di gravidanza eseguito al giorno 1 del trattamento risulti positivo.
    11. Malattie del SNC (meningea e / o coinvolgimento del cervello da linfoma) o coinvolgimento testicolare.
    12. Storia di insufficienza epatica o renale clinicamente rilevante; disturbi significativi polmonari, gastrointestinali, endocrini, neurologici, reumatologici, ematologici, psichiatrici o metabolici.
    13. Anamnesi positiva per una delle seguenti condizioni cardiovascolari:
    o infarto del miocardico entro 2 anni dall’arruolamento nello studio
    o Insufficienza cardiaca di Classe III o IV in accordo con New York Heart Association
    (NYHA)
    o Evidenza di patologie cardiovascolari non controllate, comprese le aritmie
    cardiache, insufficienza cardiaca congestizia (CHF), angina pectoris, o prova
    elettrocardiografica di ischemia acuta o di anomalie attive del sistema di
    conduzione cardiaca;
    o Evidenza di una frazione di eiezione ventricolare sinistra <50% (esame effettuato
    entro 6 mesi dalla prima dose del farmaco sperimentale)
    14. Infezioni opportunistiche attive.
    15. Positività nota al virus dell’HIV (Virus dell’immunodeficienza acquisita umana), dell’Epatite C o infezione attiva da virus dell’Epatite B.
    16. Precedente trapianto allogenico di cellule staminali.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the overall objective response rate (ORR).
    tasso di risposta globale (ORR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    E.5.2Secondary end point(s)
    • Duration of response
    • Complete remission (CR) rate
    • Progression-free survival (PFS) at one year
    • Overall survival (OS) at one year
    • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
    • Durata della risposta
    • 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    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 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) 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state25
    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)
    Patients will be followed for about 3 years and a half from the entrance into the study. At the end of this period, the patients will be followed according to the standards of the enrolling centers.
    I pazienti saranno seguiti per circa 3 anni e mezzo dall’ingresso nello studio. Al termine di questo periodo i pazienti saranno seguiti secondo gli standard dei centri arruolanti.
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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