Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   31102   clinical trials with a EudraCT protocol, of which   4846   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-002722-13
    Sponsor's Protocol Code Number:BV-ICE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-002722-13
    A.3Full title of the trial
    Phase I/II feasibility study of Brentuximab Vedotin in refractory / relapsed Hodgkin lymphoma patients who are treated by chemotherapy (ICE) in second line and eligible for autologous transplantation
    Etude de faisabilité de phase I/II du Brentuximab vedotin chez des patients atteints d'un Lymphome de Hodgkin en rechute ou réfractaire, traités par chimiothérapie (ICE) en seconde ligne et éligibles à l'autogreffe.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Brentuximab Vedotin in refractory / relapsed Hodgkin lymphoma patients who are treated by chemotherapy (ICE)
    Etude du Brentuximab vedotin chez des patients atteints d'un Lymphome de Hodgkin en rechute ou réfractaire, traités par chimiothérapie (ICE)
    A.3.2Name or abbreviated title of the trial where available
    BV-ICE
    A.4.1Sponsor's protocol code numberBV-ICE
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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: 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 organisationLYSARC
    B.5.2Functional name of contact pointSabine BALOUET
    B.5.3 Address:
    B.5.3.1Street AddressCH LYON SUD - Ste Eugénie - Pav 6D
    B.5.3.2Town/ cityPIERRE BENITE CEDEX
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472 66 93 33
    B.5.5Fax number+33426 07 40 55
    B.5.6E-mailsabine.balouet@lysarc.org
    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 ADCETRIS
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 SGN-35
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/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.3.9.2Current sponsor codeSGN35
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Hodgkin Lymphoma
    Lymphome de Hodgkin
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Lymphome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    To determine the MTD and/or RP2D (Recommended Phase II dose) of BV when administered to adult Hodgkin’s lymphoma patients treated with ICE.
    Phase II
    To evaluate the efficacy of BV in patient treated with ICE as first salvage treatment (establish the fraction of responding patients – metabolic CR) acccording to Lugano classification after the second cycle.
    Phase I
    Déterminer la DMT et/ou DRP2 (dose recommandée Phase II) de BV administré à des patients adultes atteints d'un Lymphome de Hodgkin traités par ICE .
    Phase II
    Evaluer l'efficacité de BV chez les patients traités par ICE en premier traitement de rattrapage (établir la fraction des patients répondeurs – CR métabolique) selon le classement de Lugano après le deuxième cycle.
    E.2.2Secondary objectives of the trial
    Phase I
    - To characterize the safety and tolerability of BV in patient treated with ICE.
    - To assess preliminary anti-tumor activity of BV in patient treated with ICE.
    Phase II
    - To assess the ORR (CR and PR) after 3 cycles of BV and ICE and one cycle of BV
    - To assess the toxicity profile of BV in patient treated with ICE
    - To assess hematological recovery after each cycle of BV and ICE
    - To assess the feasibility of harvesting an autologous peripheral blood stem cell graft after BV in patient treated with ICE
    - To assess the fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT
    - To assess the number of patients with PET 4 negative if the PET 2 is positive
    - To evaluate PFS and OS with this treatment regimen

    Exploratory objectives :
    - To identify predictive factors for response, PFS and OS (for phase II only)
    Phase I
    - Caractériser la sécurité et la tolérabilité du BV chez des patients traités par ICE
    - Evaluer l'activité anti-tumorale préliminaire de BV chez des patients traités par ICE
    Phase II
    - Evaluer l'ORR (CR et PR) après 3 cycles de BV et ICE et 1 cycle de BV
    - Evaluer le profil de toxicité de BV chez des patients traités par ICE
    - Evaluer la récupération hématologique après chaque cycle de BV et ICE
    - Evaluer la faisabilité de la collecte de cellules souches de sang périphérique pour une greffe autologue après BV chez des patients traités par ICE
    - Evaluer la fraction de patients (CR/PR) éligibles pour une auto- PBSCT qui reçoivent réellement une ou deux auto-PBSCT
    - Evaluer le nombre de patients PET 4 négatif si le PET 2 est positif
    - Evaluer la PFS et l'OS avec ce schéma thérapeutique

    Objectifs exploratoires :
    - Evaluer les facteurs prédictifs de réponse, PFS, OS ^(phase II uniquement)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed CD30+ HL, primarily
    refractory to first line chemotherapy or in first relapse after any
    polychemotherapy regimen
    2. Measurable disease defined as at least one single node or tumor
    lesion on CT scan > 1.5 cm
    3. FDG-PET/ CT realized at relapse and positive.
    4. Age ≥ 18 years and up to 65 years
    5. ECOG Performance Status ≤ 2
    6. Life expectancy of > 3 months with treatment
    7. No major organ dysfunction, unless HL-related
    8. Normal cardiac and pulmonary function for auto transplantation
    9. Eligible for high dose chemotherapy and autologous peripheral
    blood stem cell transplantation
    10. Resolution of toxicities from first-line therapy
    1. LH CD30+ confirmé sur le plan histologique, réfractaire à la première de ligne de chimiothérapie, ou première rechute après n'importe quel régime de polychimiothérapie
    2. Maladie mesurable définie comme au moins un noeud ou lésion tumorale sur CT scan > 1,5 cm
    3. TEP-CT réalisé à la rechute et positif
    4. ≥ 18 ans et jusqu'à 65 ans
    5. ECOG ≤ 2
    6. Espérance de vie > 3 mois avec traitement
    7. Aucun dysfonctionnement organique important, sauf si associé à LH
    8.. Fonction cardiaque et pulmonaire normale pour la transplantation
    9. Eligible à une chimiothérapie haute dose et à la transplantation autologue de cellules souches de sang périphérique
    10. Résolution des toxicités de la première ligne de traitement
    E.4Principal exclusion criteria
    1. Peripheral sensory or motor neuropathy grade ≥ 2
    2. Any chemotherapy, radiotherapy, immunotherapy or
    investigational, therapy for treatment of lymphoma within 28 days
    prior C1D1
    3. Patient who have been treated by first line of treatment with
    brentuximab vedotin alone or in combination
    4. Female patients who are both lactating and breast feeding or
    have a positive serum pregnancy test during the screening period
    or a positive pregnancy test prior C1D1
    5. Patients with active, uncontrolled infections (requiring systemic
    antibiotics within two weeks prior to treatment
    6. Prior history of another cancer unless the subject has been free
    of the disease for ≥ 3 years (with the exception of non-melanoma
    skin cancer, completely resected melanoma TNMpT1 or
    carcinoma in situ of the uterine cervix)
    7. Known cerebral or meningeal disease (HL or any other etiology),
    including signs or symptoms of PML
    8. Patients with known HIV seropositivity, hepatitis B, hepatitis
    C (Ag detection of HBs Antigen or presence of anti HBc
    antibody without detectable anti HBs antibody)
    9. Patients having received radiation therapy within 8 weeks prior
    C1D1
    1. Neuropathie sensorielle ou motrice grade ≥ 2
    2. Toute chimiothérapie, radiothérapie, immunothérapie ou traitement expérimental, pour le traitement du lymphome dans les 28 jours avant C1D1
    3. Patients traités en première ligne de traitement avec brentuximab védotine seul ou en combinaison
    4. Patientes qui allaitent ou qui présentent un test sérologique de grossesse positif pendant la période de screening ou test de grossesse positif avant C1D1
    5. Patients atteints d'infections actives et incontrôlées (nécessitant des antibiotiques systémiques dans les deux semaines avant le traitement)
    6. Antécédents d'un autre cancer à moins que le sujet soit en remission depuis plus de 3 ans (à l'exception des cancers cutanés non mélanocytaires, mélanome TNMpT1 totalement réséqué ou carcinome in situ du col utérin)
    7. Maladie cérébrale ou méningée (LH ou toute autre étiologie), y compris les signes ou symptômes de PML
    8. Patients séropositivifs pour VIH, hépatite B ou hépatite C (Ag HBs+, Ac HBc+n Ac HBs-)
    9. Patients ayant reçu une radiothérapie dans les 8 semaines avant C1D1
    E.5 End points
    E.5.1Primary end point(s)
    Phase I : MTD
    Phase II : metabolic CR
    Phase I : DLT
    Phase II : RC metabolique
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I : end of treatment
    Phase II : end of treatment
    Phase I : fin de traitement
    Phase II : fin de traitement
    E.5.2Secondary end point(s)
    Phase I
    - Efficacy, Safety
    - Anti-tumor activity
    Phase II
    - ORR (CR and PR) after 3 cycles of BV and ICE and one cycle of BV
    - toxicity profile of BV
    - hematological recovery after each cycle of BV and ICE
    - feasibility of harvesting an autologous peripheral blood stem cell graft after BV in patient treated with ICE
    - fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT
    - number of patients with PET 4 negative if the PET 2 is positive
    - PFS
    - OS
    Phase I
    - efficacité, sécurité
    - activité antitumorale
    Phase II
    - ORR (RC et RP) après 3 cycles de BV et de ICE et un cycle de BV
    - profil de toxicité de BV
    - récupération hématologique après chaque cycle de BV et de ICE
    - faisabilité d'une greffe autologue de cellules souches de sang périphérique après BV chez des patients traités par ICE
    - fraction des patients (Rc/RP) éligibles pour une auto-PBSCT qui subissent réellement une ou deux auto-PBSCT
    - nombre de patients avec PET 4 négatif si PET 2 positif
    - PFS
    - OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I : end of treatment
    Phase II
    - ORR : after 3 cycles of BV and ICE and one cycle of BV
    - toxicity profile of BV : end of treatment
    - hematological recovery : after each cycle of BV and ICE
    - feasibility of auto-PBSCT : end of treatment
    - fraction of patients (CR/PR) eligible for auto- PBSCT who actually undergo one or two auto-PBSCT : end of treatment
    - number of patients with PET 4 negative if the PET 2 is positive : PET 4
    - PFS : end of study
    - OS : end of study
    Phase I: fin du traitement
    Phase II
    - ORR : après 3 cycles de BV et ICE et 1 cycle de BV
    - profil de toxicité de BV : fin de traitement
    - récupération hématologique : après chaque cycle de BV et ICE
    - faisabilité de l'auto-PBSCT : fin du traitement
    - fraction des patients (CR/PR) éligibles pour auto-PBSCT qui subissent réellement une ou deux auto-PBSCT : fin du traitement
    - nombre de patients avec PET 4 négatif si PET 2 positif: PET 4
    - PFS : fin d'étude
    - OS: fin d'étude
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Maximal Tolerated Dose
    Dose Limite Tolérée
    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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Yes
    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
    LVLP
    Dernière visite du dernier patient
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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: 55
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    Subjects will be followed according to the standard of care in the center.
    Les patients seront suivis selon les soins standards du centre
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-Fri Sep 22 14:34:19 BST 2017 | 30 Churchill Place, Canary Wharf, London E14 5EU
    Legal notice
    EMA HMA