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    Summary
    EudraCT Number:2017-001551-31
    Sponsor's Protocol Code Number:BGB-3111-304
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-01-19
    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 number2017-001551-31
    A.3Full title of the trial
    An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    Étude de phase 3, Randomisée, en Ouvert, Internationale, Evaluant le BGB-3111 par rapport à la Bendamistine plus Rituximab chez des Patients Atteints de Leucémie Lymphoïde Chronique ou Lymphome Lymphocytique Non Précédemment Traités.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    Étude de phase 3 sur le BGB-3111 par rapport à la Bendamustine plus Rituximab chez des Patients Atteints de Leucémie Lymphoïde ou Lymphome Lymphocytique Non Précédemment Traités
    A.4.1Sponsor's protocol code numberBGB-3111-304
    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 SponsorBeiGene, Ltd.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Ltd.
    B.5.2Functional name of contact pointUS
    B.5.3 Address:
    B.5.3.1Street AddressUS
    B.5.3.2Town/ cityUS
    B.5.3.3Post codeUS
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@beigene.com
    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 No
    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 nameBGB-3111
    D.3.2Product code BGB-3111
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet established
    D.3.9.1CAS number 1691249-45-2
    D.3.9.2Current sponsor codeBGB-3111
    D.3.9.4EV Substance CodeSUB184615
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Levact
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBendamustine
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to mg/ml
    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 No
    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
    Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    Leucémie Lymphoïde Chronique ou Lymphome Lymphocytique
    E.1.1.1Medical condition in easily understood language
    Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    Leucémie Lymphoïde Chronique ou Lymphome Lymphocytique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003946
    E.1.2Term B-Lymphocytic, CLL (Kiel Classification)
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10041152
    E.1.2Term Small lymphocytic lymphoma, consistent with CLL (Working Formulation)
    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
    To compare efficacy between treatment groups in cohort 1, as measured by progression-free survival determined by independent central review
    Comparer l'efficacité entre les groups de traitment dans la cohort 1, en mesurant la survie sans progression determine par un examen centralize independent
    E.2.2Secondary objectives of the trial
    To evaluate efficacy in cohort 1, as measured by the following:
    o Overall response rate determined by independent central review and by investigator assessment
    o Overall survival
    o Duration of response determined by independent central review and by investigator assessment
    o Progression-free survival determined by investigator assessment
    o Patient-reported outcomes
    • To evaluate efficacy in cohort 2 (patients with del[17p]), as measured by the following:
    o Overall response rate determined by independent central review
    o Overall survival
    o Progression-free survival determined by independent central review
    o Duration of response determined by independent central review
    • To compare safety between the treatment groups in cohort 1
    • To evaluate pharmacokinetics of BGB-3111
    • Evaluer l'efficacité dans la cohort 1, en mesurant ce qui suit :
    o Taux de réponse globale determine par une revue central indépendante et par l'évaluation de l'investigateur
    o Survie globale
    o Durée de réponse determine par une revue centrale indépendante et par l'évaluation de l'investigateur
    o Survie sans progression determine par l'évaluation de l'investigateur
    o Résultats rapports par les patients.
    • Evaluer l'efficacité dans la cohort 2 (patients avec del[17p]), en mesurant ce qui suit :
    o Taux de réponse globale determine par une revue centrale indépendante
    o Survie globale
    o Survie sans progression determine par une revue centrale indépendante
    o Durée de réponse determine par une revue centrale indépendante.
    • Comparer la sécurité d'emploi entre les groupes de traitement dans la cohort 1
    • Evaluer la pharmacocinétique du BGB-3111
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Unsuitable for chemoimmunotherapy with FCR in the opinion of the investigator
    2. Confirmed diagnosis of CD20-positive CLL or SLL that meets the CLL criteria (Hallek et al, 2008)
    3. Binet Stage C disease, or Binet Stage B or A disease requiring treatment as defined by at least one of the criteria (Hallek et al, 2008)
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    5. Life expectancy ≥ 6 months
    6. Adequate bone marrow function
    7. Patient must have adequate organ function
    8. Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of BGB-3111, 3 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.
    9. Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for ≥ 90 days after the last dose of BGB-3111 or 3 months after the last dose of bendamustine whichever is longer.
    10. Ability to provide written informed consent and can understand and comply with the requirements of the study
    1. non éligibles à la chimio-immunothérapie avec la fludarabine, le cyclophosphamide et le rituximab (FCR) selon l'avis de l'investigateur
    2. diagnostic confirmé de LLC ou de LPL CD20 positif(-ve) qui remplit les critère de la LLC (Hallek et al, 2009)
    3. une maladie de stade C de Binet, ou une maladie de stade B ou A de Binet nécessitant un traitement, comme défini par au moins l’un des critères (Hallek et al. 2008)
    4. Indice de performance du groupe coopératif d’experts en oncologie de la côte Est des États-Unis (Eastern Cooperative Oncology Group, ECOG) de 0 à 2
    5. Esperance de vie ≥ 6 mois
    6. Fonction médullaire non altérée
    7. Le patient doit avoir la function des organes non altérée
    8. Les patientes en âge de procréer doivent utiliser des méthodes de contraception hautement efficaces avant de recevoir la première dose du médicament à l'étude, pendant toute la durée de l'étude et pendant 90 jours après la dernière dose de BGB-3111, 3 mois après la dernière dose de bendamustine ou 12 mois après la dernière dose de rituximab, selon la période la plus longue,
    9. Les patients sont éligibles s'ils sont vasectomisés ou s'ils acceptent l'utilisation de la contraception barrière avec d'autres méthodes décrites ci-dessus pendant la période de traitement et pendant 90 jours après la dernière dose de BGB-3111 ou 3 mois après la dernière dose de bendamustine, selon la période la plus longue,
    10. Capacité de fournir un consentement éclairé écrit et à comprendre et se conformer aux exigences de l'étude
    E.4Principal exclusion criteria
    1. Previous systemic treatment for CLL/SLL
    2. Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation
    3. Clinically significant cardiovascular disease
    4. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
    5. History of severe bleeding disorder
    6. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
    7. Severe or debilitating pulmonary disease
    8. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
    9. Active fungal, bacterial and/or viral infection requiring systemic therapy
    10. Known central nervous system involvement by leukemia or lymphoma
    11. Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
    12. Known infection with HIV, or serologic status reflecting active hepatitis B or C infection
    13. Major surgery within 4 weeks of the first dose of study drug
    14. Pregnant or lactating women
    15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
    16. Ongoing alcohol or drug addiction
    17. Hypersensitivity to BGB-3111, bendamustine, or rituximab or any of the other ingredients of the study drugs
    18. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
    19. Concurrent participation in another therapeutic clinical trial.
    1. Précédent traitement systemic pour le traitement du LLC/LPL
    2. Antécédent de leucémie prolymphocytaire ou de syndrome de Richter
    3. maladie cardiovasculaire cliniquement significative
    4. Malignité antérieure au cours des 3 dernières années, sauf pour le cancer de la peau basal ou épidermoïde traité curativement, le cancer superficiel de la vessie ou le carcinome in situ du col de l'utérus ou du sein
    5. Antécédents de troubles d'hémoragies graves
    6. Antécédents d'accident vasculaire cérébral ou d'hémorragie intracrânienne dans les 6 mois précédant la première dose de médicament à l'étude
    7. maladie pulmonaire grave ou invalidante
    8. Incapacité à avaler des gélules ou une maladie affectant significativement la fonction gastro-intestinale comme le syndrome de malabsorption, la résection de l'estomac ou de l'intestin grêle, les interventions de chirurgie bariatrique, maladie intestinale inflammatoire symptomatique ou l'obstruction intestinale partielle ou complète
    9. Infection fongique, bactérienne et / ou virale active nécessitant une thérapie systémique
    10. Implication connue du système nerveux central par une leucémie ou un lymphoma
    11. Etat de santé sous-jacent,qui, de l'avis de l'investigateur, rendront l'administration du médicament à l'étude dangereuse ou obscurciront l'interprétation de la toxicité ou des EI
    12. infection active avec l’hépatite B ou C ou le VIH
    13. Chirurgie majeure dans les 4 semaines suivant la première dose du médicament à l'étude
    14. Femmes enceintes ou allaitantes
    15. Vaccination avec un vaccin vivant dans les 35 jours précédant la première dose du médicament à l'étude
    16. Alcoolisme ou toxicomanie en cours
    17. Hypersensibilité au BGB-3111, à la bendamustine et au rituximab ou à l'un des autres composants des médicaments de l'étude
    18. Patient nécessitant un traitement continu avec un puissant inhibiteur ou inducteur du CYP3A
    19. Participation simultanée à un autre essai clinique thérapeutique.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival in cohort 1 (patients without del[17p]) determined by independent central review using the iwCLL guidelines with modification for treatment-related lymphocytosis, and defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
    Le critère principal est la survie sans progression dans la cohorte 1 (patients sans del [17p]) déterminée par une revue centrale indépendante en utilisant les recommandations iwCLL avec modification du traitement pour la lymphocytose, et définie comme le délai entre la randomisation et la date de la première la progression de la maladie ou la mort, selon la première éventualité.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 interim analysis of progression-free survival by independent central review in cohort 1, performed when approximately 79 events (67% of the target number of events at final analysis) from the arms A and B are observed. It is estimated that it will take approximately 25 months to observe 79 events. The final analysis of progression-free survival will take place after 118 events are observed, which is estimated as approximately 35 months from study start.

    1 analyse intermédiaire de la survie sans progression par revue centrale indépendante dans la cohorte 1, réalisée lorsqu'environ 79 événements (67% du nombre cible d'événements à l'analyse finale) des bras A et B sont observés. On estime qu'il faudra environ 25 mois pour observer 79 événements. L'analyse finale de la survie sans progression aura lieu après l'observation de 118 événements, estimée à environ 35 mois du début de l'étude.
    E.5.2Secondary end point(s)
    • Overall response rate in cohort 1 defined as the proportion of patients who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by independent central review and by investigator assessment
    • Overall survival in cohort 1 defined as the time from randomization to the date of death due to any reason
    • Duration of response in cohort 1 determined by independent central review and by investigator assessment using the iwCLL criteria with modification for treatment-related lymphocytosis, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first
    • Progression-free survival in cohort 1 determined by investigator assessment
    • Patient-reported outcomes in cohort 1 measured by the EQ-5D-5L and EORTC QLQ-C30 questionnaires
    • Overall response rate in cohort 2 (patients with del[17p]) determined by independent central review
    • Overall survival in cohort 2
    • Progression-free survival in cohort 2 determined by independent central review
    • Duration of response in cohort 2 determined by independent central review
    • Safety parameters, including AEs, SAEs, clinical laboratory tests, physical exams, and vital signs
    • Pharmacokinetic parameters such as apparent clearance of the drug from plasma (CL/F) and AUC0-12
    • Taux de réponse global dans la cohorte 1 défini comme la proportion de patients qui obtiennent une réponse complète, une réponse complète avec récupération incomplète de la moelle osseuse, réponse partielle ou réponse partielle avec lymphocytose, déterminée par une revue centrale indépendante et par l'évaluation de l'investigateur,
    • Survie globale dans la cohorte 1 définie comme le temps écoulé entre la randomisation et la date du décès, pour quelque raison que ce soit
    • Durée de la réponse dans la cohorte 1 déterminée par un examen central indépendant et par l'investigateur en utilisant les critères iwCLL avec modification du traitement de la lymphocytose, et définie comme la date à laquelle les critères de réponse sont satisfaits jusqu'à la date à laquelle la progression de la maladie est objectivement documentée ou la mort, selon la première éventualité
    • Survie sans progression dans la cohorte 1 déterminée par l'évaluation de l'investigateur
    • Résultats rapportés par les patients dans la cohorte 1 mesurés par les questionnaires EQ-5D-5L et EORTC QLQ-C30
    • Taux de réponse global dans la cohorte 2 (patients avec del [17p]) déterminé par un examen central indépendant
    • Survie globale dans la cohorte 2
    • Survie sans progression dans la cohorte 2 déterminée par un examen central indépendant
    • Durée de la réponse dans la cohorte 2 déterminée par un examen central independent
    • Paramètres de sécurité, y compris les EI, les EIG, les tests de laboratoire clinique, les examens physiques et les signes vitaux
    • Les paramètres pharmacocinétiques tels que la clairance apparente du médicament à partir du plasma (CL/F) et AUC0-12
    E.5.2.1Timepoint(s) of evaluation of this end point
    At time of interim analysis if the PFS comparison between the 2 arms in cohort 1 crosses the stopping boundary. Or at the time of final PFS analysis.
    Au moment de l'analyse intermédiaire, si la comparaison de la survie sans progression entre les deux bras de la cohorte 1 franchit la limite d'arrêt. Ou au moment de l'analyse finale de la survie sans progression.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Czech Republic
    France
    Hungary
    Italy
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 374
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 467
    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 receiving BGB-3111, who in the opinion of the investigator, continue to benefit from study treatment may continue treatment with BGB-3111 by enrolling on the BGB-3111 Long Term Extension Study.
    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 Decision2018-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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