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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-003700-44
    Sponsor's Protocol Code Number:BGB-A317-207
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-003700-44
    A.3Full title of the trial
    A Phase 2, Open-Label Study of BGB-A317 in Patients with Relapsed or Refractory Mature T- and NK-cell Neoplasms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, open-label, phase 2 clinical study to evaluate the safety and efficacy of the investigational drug BGB-A317 in patients with T-cell or NK-cell lymphoma
    A.4.1Sponsor's protocol code numberBGB-A317-207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03493451
    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. c/o BeiGene USA, Inc.
    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 AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    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 nameTislelizumab
    D.3.4Pharmaceutical form 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 INNTislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    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 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
    Relapsed or Refractory Mature T- and NK-cell Neoplasms
    E.1.1.1Medical condition in easily understood language
    Mature T-cell and nature killer (NK)-cell lymphomas are lymphoid malignancies that are derived from proliferation of mature post-thymic lymphocytes.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025321
    E.1.2Term Lymphomas non-Hodgkin's T-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 efficacy of tislelizumab in patients Relapsed or Refractory Mature T- and NK-cell Neoplasms as measured by overall response rate and determined by investigator.
    • For cohorts 1 and 2, overall response rate will be measured using the Lugano criteria (Cheson et al 2014) with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for immunomodulatory drugs (Cheson et al 2016).
    • For cohort 3, overall response rate will be measured using the International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines (Olsen et al 2011).
    E.2.2Secondary objectives of the trial
    For cohorts 1 and 2, efficacy measures will be determined using the Lugano criteria (Cheson et al 2014) with LYRIC modification for
    immunomodulatory drugs (Cheson et al 2016). For cohort 3, efficacy measures will be determined using the ISCL/EORTC guidelines (Olsen et al 2011).
    • To evaluate the efficacy of tislelizumab, as determined by the investigator and measured by the following:
    - Duration of response for all cohorts
    - Progression-free survival for all cohorts
    - Overall survival for cohorts 1 and 2
    - Rate of complete response or complete metabolic response for all cohorts
    - Time to response for all cohorts
    - Patient-reported outcomes (EQ-5D-5L and EORTC QLQ-C30) for all cohorts
    • To evaluate safety and tolerability of tislelizumab for all cohorts
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of relapsed or refractory, mature Tcell and NK-cell neoplasms based on the WHO 2016 classification of tumors of hematopoietic and lymphoid tissue. Patients will be allocated to three cohorts based on their histologic diagnosis:
    • Cohort 1: Extranodal NK/T-cell lymphoma (nasal or non-nasal type)
    ➢ Patients with aggressive NK leukemia are excluded
    • Cohort 2: Other mature T-cell neoplasms, limited to the following
    histologies:
    ➢ Peripheral T-cell lymphoma - not otherwise specified (PTCL-NOS)
    ➢ Angioimmunoblastic T-cell lymphoma (AITL)
    ➢ Anaplastic large cell lymphoma (ALCL)
    • Cohort 3: Stage IB-IVB cutaneous T-cell lymphomas, limited to the following histologies:
    ➢ Mycosis fungoides (MF)
    ➢ Sèzary syndrome (SS)
    2. Male or female ≥ 18 years of age at the time of informed consent (or
    acceptable age according to local regulations, whichever is older)
    3. Previously received 1 or more appropriate systemic therapies (e.g. non-anthracycline based regimens such as L-asparaginase-based therapy) for cohort 1 or combination chemotherapy (e.g. CHOP, EPOCH, or similar therapy) for cohort 2. Radiation therapy alone would not be acceptable as previous therapy
    • For patients with relapsed or refractory anaplastic large cell lymphoma regardless of anaplastic lymphoma kinase (ALK) status, must have received prior therapy with brentuximab vedotin (applicable only to countries where brentuximab vedotin received marketing approval)
    4. Disease progression during or after completion of most recent therapy or refractory disease. Refractory disease is defined as failure to achieve CR or PR to most recent therapy, and most recent therapy was an appropriate systemic therapy for mature T-cell or NK-cell lymphoma
    5. For cohorts 1 and 2, patients must have lesions that are measurable by imaging, where measurable is defined as ≥ 1 lesion that is > 1.5 cm for nodal lesions and > 1 cm for extranodal lesions.
    For cohort 3, patients are not required to have measurable disease by imaging.
    6. Availability of either unstained tissue (block or unstained slides) or stained slides, and pathology report for central confirmation of mature T-cell or NK-cell lymphoma. If stained slides or unstained tissue (block or unstained slides) are not available or are insufficient, a fresh tumor tissue sample is mandatory for central pathology. Central pathology confirmation is not required prior to enrollment.
    7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see table 3 in protocol).
    8. Has life expectancy ≥ 6 months.
    9. Patients must have forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test
    (PFT), carbon monoxide diffusion capacity (DLCO) > 60% predicted value, and FEV1 and FVC > 50% predicted value; all PFTs must be obtained within 4 weeks prior to the first dose of tislelizumab.
    10. Adequate organ function defined as:
    • Absolute neutrophil count (ANC) > 1000/mm3(without growth factor
    support within 7 days of ANC measurement)
    • Platelet > 50000/mm3(without growth factor support or transfusion
    within 7 days of platelets measurement)
    • Hemoglobin > 80 g/L (prior transfusion is acceptable)
    • Creatinine clearance ≥ 30 ml/min (as estimated by the CockcroftGault
    equation or as measured by nuclear medicine
    scan or 24-hour urine collection) (see Appendix 9 of protocol)
    • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic
    transaminase, and alanine aminotransferase
    (ALT)/serum glutamic pyruvic transaminase ≤ 3.0 × upper limit of
    normal (ULN)
    • Serum total bilirubin < 2.0 × ULN (unless documented Gilbert's
    syndrome)
    11. Female patients of childbearing potential must be willing to use a highly effective method of birth control/contraception for the duration of the study, and for at least 120 days after the last dose of tislelizumab, and have a negative serum pregnancy test within 7 days of the first dose of study drug. Please refer to Appendix 4 for a list of acceptable birth control/contraception methods and contraceptive guidelines.
    12. Non-sterile males must be willing to use a highly effective method of
    birth control/contraception for the duration of the study and for at least
    120 days after the last dose of tislelizumab
    • Sterile males are those for whom azoospermia, in a semen sample examination, has been demonstrated as definitive evidence of infertility.
    • Males with “low sperm counts” (consistent with “sub-fertility”) are not to be considered sterile for purposes of this study.
    13. Ability to provide written informed consent and can understand and
    comply with the requirements of the study

    E.4Principal exclusion criteria
    1. Known central nervous system involvement by leukemia or lymphoma
    2. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agent
    3. Meets one of the following scenarios for hematopoietic stem cell transplantation and/or chimeric antigen receptor T cell (CAR-T) therapy:
    • Is eligible for autologous or allogeneic stem cell transplantation, unless patient has refused transplantation
    • Has undergone prior allogeneic hematopoietic stem cell transplantation or organ transplantation
    • Has received autologous stem cell transplantation within 6 months prior to first dose of study drug
    • Has received CAR-T therapy within 12 months prior to first dose of study drug
    4. Has received:
    • Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks (or 5 half-lives, whichever is shorter) prior to study Day 1
    • Recent treatment with another monoclonal antibody within 4 weeks prior to study Day 1
    • Investigational treatment or device within 4 weeks (or 5 half-lives, whichever is shorter) prior to study Day 1
    • For cohort 3 patients, phototherapy within 2 weeks or any topical
    therapy within 1 week prior to study Day 1
    •Or has not recovered from AEs (ie, ≤ Grade 1 or baseline level) due to prior therapy
    5. Concurrent or prior malignancy within the past 3 years, except for curatively treated
    basal or squamous cell skin cancer, superficial bladder cancer, carcinoma
    in situ of the cervix or breast, or localized Gleason score 6 or lower
    prostate cancer
    6. Active autoimmune diseases or history of autoimmune diseases that
    may relapse (see Appendix 3) Note: Patients with the following diseases
    are not excluded and may proceed to further screening:
    a. Type I diabetes under control
    b. Hypothyroidism (provided it is managed with hormone replacement
    therapy only)
    c. Controlled celiac disease
    d. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis,
    alopecia) except when such diseases significantly interfere with
    response assessment of patients in cohort 3
    e. Any other disease that is not expected to recur in the absence of
    external triggering factors
    7. Has known history of interstitial lung disease, non-infectious
    pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of
    dyspnea at rest or pulse oximetry of < 92% while breathing room air
    8. Has any condition that required systemic treatment with either
    corticosteroids (> 10 mg daily of prednisone or equivalent) or other
    immunosuppressive medication within 14 days before study drug
    administration. Note: Patients who are currently or have previously been
    on any of the following steroid regimens are not excluded:
    a. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or
    equivalent)
    b. Topical, ocular, intra-articular, intranasal, or inhalational
    corticosteroid with minimal systemic absorption except when given for
    treatment of MF or SS
    c. Short course (≤ 7 days) of corticosteroid prescribed prophylactically
    (eg, for contrast dye allergy) or for the treatment of a non-autoimmune
    condition (eg, delayed-type hypersensitivity reaction caused by contact
    allergen
    9. Has a known active TB (Bacillus Tuberculosis) infection
    10. Known infection with HIV, human T-cell lymphotropic virus (HTLV)-1, -2, or serologic status reflecting active hepatitis B or C infection as follows:
    • Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity ≤ 20 IU/mL. If so, patients may either undergo regularly scheduled monitoring of HBV DNA or less frequent monitoring of HBV DNA while on prophylactic antiviral medication as defined by regional standard of care.
    • Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible only if HCV RNA is undetectable.
    11. Active fungal, bacterial, and/or viral infection requiring systemic
    therapy
    12. Vaccination with a live vaccine within 35 days prior to the first dose
    of study drug
    13. Clinically significant cardiovascular disease including the following:
    • Myocardial infarction within 6 months before screening
    Unstable angina within 3 months before screening
    • New York Heart Association Classification III or IV congestive heart
    failure
    (Appendix 5)
    • History of clinically significant arrhythmias (please refer to the protocol)
    14. Major surgery within 4 weeks of the first dose of study drug
    15. Ongoing alcohol or drug addiction
    16. Underlying medical or social conditions that, in the opinion of the investigator
    and/or medical monitor, will render the administration of study drug
    hazardous or obscure the interpretation of safety or efficacy results.

    Please refer to the protocol for the remaining exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall response rate as determined by investigator. Overall response rate is defined as the proportion of
    patients achieving a best overall response of complete response or partial response. Efficacy will be assessed every 12 weeks for 96 weeks, then every 24 weeks for an additional 96 weeks, and then yearly until
    disease progression.
    • For cohorts 1 and 2, overall response rate will be measured using the Lugano criteria (Cheson et al 2014) with LYRIC modification for immunomodulatory drugs (Cheson et al 2016).
    • For cohort 3, overall response rate will be measured using the ISCL/EORTC guidelines (Olsen et al 2011).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy will be assessed every 12 weeks for 96 weeks, then every 24
    weeks for an additional 96 weeks, and then yearly until disease
    progression.
    E.5.2Secondary end point(s)
    • For cohorts 1 and 2, efficacy measures will be determined using the Lugano criteria (Cheson et al 2014) with LYRIC modification for immunomodulatory drugs (Cheson et al 2016). For cohort 3, efficacy measures will be determined using the ISCL/EORTC guidelines (Olsen et al 2011). All measures will be assessed by the investigator.
    • Duration of response defined as the time from the first determination of an objective response until progression or death, whichever occurs first, for all cohorts
    • Progression-free survival defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, for all cohorts
    • Overall survival, defined as the time from first study drug administration to the date of death due to any reason, for cohorts 1 and
    2
    • Rate of complete response or complete metabolic response defined as the proportion of patients who achieve complete response or complete metabolic response as best overall response, for all cohorts
    • Time to response defined as the time from first study drug administration to the time the response criteria (complete response or
    partial response) are first met, for all cohorts
    • Patient-reported outcomes measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires for all cohorts
    • Safety parameters, including AEs, SAEs, clinical laboratory tests, physical exams, and vital signs for all cohorts
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) Duration of response until progression or death, whichever occurs
    first, for all cohorts
    B) Progression-free survival at selected timepoints, for all cohorts
    C) Overall Survival (OS) at selected timepoints, for cohorts 1 and 2
    D) Rate of complete response or complete metabolic response, for all
    cohorts
    E) Time-to-response at selected timepoints, for all cohorts
    F) The EORTC QLQ-C30 and EQ-5D-5L questionnaires will be summarized
    for each assessment timepoint, for all cohorts
    G) Safety and Pharmacokinetic parameters as assessed by investigator
    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 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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Canada
    China
    France
    Germany
    Hong Kong
    Italy
    Taiwan
    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
    Study termination is defined as the time point when data collection will stop and the final analysis of the study will occur. The study will continue until the last patient has died, becomes lost to follow-up, or withdraws from study, or until sponsor decides to terminate the study.


    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years3
    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: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 130
    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)
    There are no plans to provide study treatment after End of the study. Patients may be transferred to commercially available drug if available or other therapy as per investigator's medical judgment.
    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 Decision2018-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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