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    Summary
    EudraCT Number:2020-000547-31
    Sponsor's Protocol Code Number:BGB-3111-LTE1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-000547-31
    A.3Full title of the trial
    Estudio abierto, multicéntrico y de extensión a largo plazo con pautas de zanubrutinib (BGB-3111) en pacientes con neoplasias malignas de linfocitos B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Un estudio multicéntrico no ciego que evalúa el tratamiento a largo plazo con regímenes de zanubrutinib (BGB-3111) en pacientes con cáncer de sangre en los ganglios linfáticos
    A.4.1Sponsor's protocol code numberBGB-3111-LTE1
    A.5.4Other Identifiers
    Name:ZanubrutinibNumber:USAN
    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 pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street Addressc/o BeiGene USA, Inc., 2955 Campus Drive, Suite 200
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94403
    B.5.3.4CountryUnited States
    B.5.4Telephone number0439-458-944
    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 nameZanubrutinib
    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 INNZANUBRUTINIB
    D.3.9.1CAS number 1691249-45-2
    D.3.9.2Current sponsor codeBGB-3111
    D.3.9.4EV Substance CodeSUB195236
    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.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
    B-cell malignancies
    neoplasias malignas de linfocitos B
    E.1.1.1Medical condition in easily understood language
    blood cancer in the lymph nodes
    cáncer de sangre en los ganglios linfáticos
    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 10003901
    E.1.2Term B-cell lymphoma NOS
    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 evaluate the long-term safety of zanubrutinib, as monotherapy or in combination, in patients with B-cell malignancies who participated in a
    BeiGene parent study for zanubrutinib
    • Evaluar la seguridad a largo plazo de zanubrutinib, en monoterapia o en terapia combinada, en pacientes con neoplasias malignas de linfocitos B que participaron en un estudio principal de BeiGene para zanubrutinib
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of zanubrutinib, as monotherapy or in combination, by measuring the following:
    - Progression-free survival (PFS)
    - Duration of response (DOR)
    - Overall survival (OS)
    • Evaluar la eficacia a largo plazo de zanubrutinib, en monoterapia o en terapia combinada, mediante la medición de lo siguiente:
    o Supervivencia sin progresión (SSP)
    o Duración de la respuesta (DR)
    o Supervivencia general (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. As part of a BeiGene parent study:
    a. Currently participating, or
    b. Participated recently

    2. Intent to continue or start zanubrutinib treatment after occurrence of any of the following:
    a. At time of final analysis or study closure of the eligible BeiGene parent study:
    •For zanubrutinib-naive patients, rationale for initiation of zanubrutinib treatment must be discussed with and approved by the medical monitor
    b. At time of progressive disease (PD) after occurrence of either of the following:
    i Patient was receiving zanubrutinib at the time of progressive disease (PD), and the investigator and patient agree it is in the patient’s best interest to continue zanubrutinib (discussion with and approval by the medical monitors of the parent study and this study required)
    ii Patient was receiving a non-BTK inhibitor drug at the time of progressive disease (PD), and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (discussion with and approval by the medical monitors of the parent study and this study required)
    c. At an alternative timepoint for an alternative reason (discussion with and approval by the medical monitor required)

    3. Patient who is currently on zanubrutinib treatment:
    Does not meet any criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
    1. Como parte de un estudio de padres de BeiGene:
    a. Participando actualmente, o
    B. Participó recientemente

    2. Tiene la intención de continuar o comenzar el tratamiento con zanubrutinib después de que ocurra cualquiera de los siguientes:
    a. En el momento del análisis final o cierre del estudio del estudio principal elegible de BeiGene:
    • Para los pacientes que no han recibido zanubrutinib, el monitor médico debe discutir y aprobar el inicio del tratamiento con zanubrutinib.
    b. En el momento de la enfermedad progresiva (EP) después de la aparición de cualquiera de los siguientes:
    i El paciente estaba recibiendo zanubrutinib en el momento de la enfermedad progresiva (EP), y el investigador y el paciente están de acuerdo en que lo mejor para el paciente es continuar con zanubrutinib (discusión y aprobación de los monitores médicos del estudio principal y este estudio requerido)
    ii El paciente estaba recibiendo un fármaco no inhibidor de BTK en el momento de la enfermedad progresiva (EP), y el investigador y el paciente están de acuerdo en que el paciente puede beneficiarse clínicamente del tratamiento con zanubrutinib (discusión y aprobación de los monitores médicos del estudio principal y este estudio requerido)
    C. En un momento alternativo por un motivo alternativo (se requiere la discusión y la aprobación del monitor médico)

    3. Paciente que está actualmente en tratamiento con zanubrutinib:
    No cumple con ningún criterio de suspensión o suspensión permanente de zanubrutinib y, en opinión del investigador, seguirá beneficiándose del tratamiento con zanubrutinib.
    E.4Principal exclusion criteria
    1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
    2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
    3. Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
    4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapy, or any prohibited concomitant therapy outlined in the protocol
    5. Pregnant or lactating woman
    6. Inability to comply with study procedures
    7. Concurrent participation in another therapeutic clinical study
    8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
    1. Se interrumpió permanentemente el tratamiento con zanubrutinib en el estudio original de BeiGene debido a toxicidad inaceptable, incumplimiento de los procedimientos del estudio o retiro del consentimiento.
    2. Infección sistémica activa no controlada o infección reciente que requiera tratamiento antimicrobiano parenteral
    3. Enfermedad potencialmente mortal, afección médica o disfunción del sistema de órganos que, en opinión del investigador, podría comprometer la seguridad del paciente, interferir con la absorción o el metabolismo de zanubrutinib o poner los resultados del estudio en un riesgo indebido.
    4. Quimioterapia concomitante, terapia dirigida, radioterapia, terapia basada en anticuerpos o cualquier terapia concomitante prohibida descrita en el protocolo.
    5. Mujer embarazada o lactante
    6. Incapacidad para cumplir con los procedimientos del estudio
    7. Participación concurrente en otro estudio clínico terapéutico
    8. Antecedentes de enfermedad progresiva (EP) mientras recibía un inhibidor de BTK (excepto zanubrutinib)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.
    • El criterio de valoración principal del estudio es la seguridad evaluada por la incidencia de todos los AA y AAG que surjan durante el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    on or after the first dose of study drug up to 30 days after the last dose of study drug or initiation of new antineoplastic therapy, whichever comes first
    durante o tras la primera dosis del fármaco del estudio y hasta 30 días después de la última dosis del fármaco del estudio o del inicio de un nuevo tratamiento antineoplásico, lo que ocurra primero.
    E.5.2Secondary end point(s)
    - PFS per investigator assessment
    - DOR per investigator assessment
    - OS
    • SSP según la evaluación del investigador
    • DR según la evaluación del investigador
    • SG
    E.5.2.1Timepoint(s) of evaluation of this end point
    - the time from the starting date of zanubrutinib to the date of first documentation of PD or death, whichever occurs first
    - the time from the date that the response criteria are first met after the start of zanubrutinib to the date that PD is documented or death
    - the time from the starting date of zanubrutinib to the date of death due to any reason
    - el tiempo desde la fecha de inicio de zanubrutinib hasta la fecha de la primera documentación de EP o muerte, lo que ocurra primero
    - el tiempo desde la fecha en que se cumplen los criterios de respuesta por primera vez después del inicio de zanubrutinib hasta la fecha en que se documenta la EP o la muerte
    - el tiempo desde la fecha de inicio de zanubrutinib hasta la fecha de muerte por cualquier motivo
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    China
    Korea, Republic of
    New Zealand
    United States
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    Greece
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 546
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 700
    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 who are continuing to receive benefit from monotherapy or combination therapy after PD based on the investigator’s assessment may remain on monotherapy or combination therapy after discussion with and approval by the medical monitor or designee.
    Los pacientes que sigan beneficiándose de la monoterapia o del tratamiento combinado después de la PE, según la evaluación del investigador, podrán seguir recibiendo la monoterapia o el tratamiento combinado después hablar con el supervisor médico o la persona designada y obtener su aprobación.
    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 Decision2022-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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