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    Summary
    EudraCT Number:2020-000547-31
    Sponsor's Protocol Code Number:BGB-3111-LTE1
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-05-16
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-000547-31
    A.3Full title of the trial
    An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B cell Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An unblinded, multi-center study evaluating long-term treatment with Zanubrutinib (BGB-3111) regimens in patients with blood cancer in the lymph nodes
    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., 1840 Gateway Drive, Third Floor
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94404
    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
    E.1.1.1Medical condition in easily understood language
    blood cancer in the lymph nodes
    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 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 regimens in patients with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of zanubrutinib regimens by measuring the following:
    - Progression-free survival (PFS)
    - Duration of response (DOR)
    - Overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. As part of a BeiGene-sponsored 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-sponsored parent study.
    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 (following discussion with the medical monitor or designee of the parent study and this study)
    *The following signs and symptoms may be indicators of non-clinically significant progression warranting continued use of zanubrutinib despite radiologic progression: absence of clinical symptoms and signs of disease progression (including clinically significant worsening of laboratory values), stable Eastern Cooperative Oncology Group Performance Scale (ECOG PS), absence of rapid progression of disease or of progressive tumor at critical anatomical sites that requires urgent alternative medical intervention. In these scenarios, investigators must inform patients that continuing treatment is not considered standard in the treatment of cancer but that in the opinion of the investigator, the patient will continue to benefit from zanubrutinib.
    ii. Patient was receiving a non-BTK inhibitor drug at the time of PD, and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (following discussion with the medical monitor or designee of the parent study and this study)
    c. At an alternative timepoint for an alternative reason not described in Inclusion Criteria 2a and 2b (following discussion with the medical monitor or designee)

    3. In the opinion of the investigator, the patient will continue to benefit from, and tolerate zanubrutinib
    a. Patient who is currently on zanubrutinib treatment:
    Does not meet any criteria for zanubrutinib hold or permanent discontinuation
    E.4Principal exclusion criteria
    1. Permanently discontinued from zanubrutinib treatment in the BeiGene-sponsored 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)
    9. Vaccination with a live vaccine within 35 days prior to first dose of study drug
    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.
    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
    E.5.2Secondary end point(s)
    - PFS per investigator assessment
    - DOR per investigator assessment
    - OS
    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
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA66
    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
    New Zealand
    Australia
    China
    Korea, Republic of
    United Kingdom
    United States
    Czechia
    France
    Germany
    Greece
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Türkiye
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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 400
    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.
    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 Decision2022-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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