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    Summary
    EudraCT Number:2012-004056-11
    Sponsor's Protocol Code Number:PCI-32765MCL3002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-004056-11
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination with Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
    A.4.1Sponsor's protocol code numberPCI-32765MCL3002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29-2333CM
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71 524 21 66
    B.5.5Fax number+31(0)71 524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code JNJ-54179060
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeJNJ-54179060
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB88115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mantle Cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    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 HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of progression-free survival (PFS) in subjects with newly diagnosed MCL who are 65 years of age or older.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
     To evaluate overall survival
     To evaluate the CR rate and overall response rate (CR+PR)
     To evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
     To evaluate the minimal residual disease (MRD) negative rate
     To evaluate duration of response
     To evaluate time-to-next treatment (TTNT)
     To evaluate the safety of ibrutinib when combined with BR
     To characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central laboratory: diagnosis must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5) and CD5 or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
    - Clinical Stage II, III, or IV by Ann Arbor Classification
    - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
    - No prior therapies for MCL
    - Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
    - Hematology and biochemical laboratory values within protocol-defined limits
    - Agrees to protocol-defined use of effective contraception
    - Negative blood or urine pregnancy test at screening
    E.4Principal exclusion criteria
    - Major surgery within 4 weeks of random assignment
    - Known central nervous system lymphoma
    - Diagnosed or treated for malignancy other than MCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
    - Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
    - History of stroke or intracranial hemorrhage within 6 months prior to random assignment
    - Requires anticoagulation with warfarin or equivalent vitamin K antagonists
    - Requires treatment with strong CYP3A inhibitors
    - Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
    - Vaccinated with live, attenuated vaccines within 4 weeks of random assignment
    - Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
    - Any 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 ibrutinib capsules, or put the study outcomes at undue risk
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to the end-of-study visit until 265 progression-free survival events have been observed (up to 7 years after the last patient is randomized)
    E.5.2Secondary end point(s)
    1) Overall survival
    Time frame = up to the end-of-study visit until 60% of all enrolled
    patients have died (up to 7 years after the last patient is randomized)

    2) Overall response rate
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    3) Number of participants with change in Lym subscale scores of the
    Functional Assessment of Cancer Therapy-Lymphoma (FACT Lym)
    Time frame = screening, Day 1 of the first 6 cycles, then every 12 weeks
    in the first 12 months, thereafter every 16 weeks up to 7 years after the
    last patient is randomized

    4) Minimal residual disease negative rate
    Time frame = for participants with complete response, every 12 weeks in
    the first 12 months, thereafter every 16 weeks and at disease
    progression or up to the end-of-study visit (up to 7 years after the last
    patient is randomized)

    5) Duration of response
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    6) Time-to-next treatment
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    7) Number of participants affected by an adverse event
    Time frame = up to 30 days after the last dose of study treatment

    8) Oral plasma clearance of ibrutinib as derived from population
    pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    9) Oral volume of distribution at steady state of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    10) Area under the concentration curve of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    11) Minimum observed plasma concentration of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    12) Maximum observed plasma concentration of ibrutinib as derived
    from population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA123
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Israel
    Japan
    Korea, Republic of
    Mexico
    Peru
    Singapore
    Taiwan
    Thailand
    United States
    France
    Poland
    Sweden
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Hungary
    Ireland
    Portugal
    Russian Federation
    Slovakia
    Turkey
    Ukraine
    United Kingdom
    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
    End of study, when 60% of the randomized subjects have died or the sponsor terminates the study, whichever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 520
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 520
    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)
    The sponsor will ensure that subjects benefiting from treatment with ibrutinib will be able to continue treatment after the end of the 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 Decision2014-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-06-24
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