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    Summary
    EudraCT Number:2013-003093-27
    Sponsor's Protocol Code Number:PCI-32765FLR3001
    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:2013-12-05
    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 number2013-003093-27
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
    Estudio fase 3, aleatorizado, doble ciego y controlado con placebo, del inhibidor de la tirosina quinasa de Bruton, PCI-32765 (ibrutinib), en combinación con bendamustina y rituximab (BR) o con rituximab, ciclofosfamida, doxorubicina, vincristina y prednisona (R-CHOP) en sujetos con linfoma no-Hodgkin indolente (LNHi) previamente tratado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients with Previously Treated Indolent Non-Hodgkin Lymphoma
    Estudio PCI-32765 (ibrutinib), en combinación con bendamustina y rituximab (BR) o con rituximab, ciclofosfamida, doxorubicina, vincristina y prednisona en sujetos con linfoma no-Hodgkin indolente previamente tratado
    A.4.1Sponsor's protocol code numberPCI-32765FLR3001
    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
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 21 66
    B.5.5Fax number+31(0)71524 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 No
    D.2.5.1Orphan drug designation number
    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.3.9.2Current sponsor codeIbrutinib
    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
    Indolent Non-Hodgkin Lymphoma (iNHL)
    Linfoma no-Hodgkin indolente
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Cancer de sangre
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10029621
    E.1.2Term Non-Hodgkin's lymphomas unspecified histology indolent
    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 (BR) combination or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combination will result in prolongation of PFS compared with either BR or R-CHOP alone in subjects with previously treated iNHL (FL or MZL).
    El objetivo principal es evaluar si la adición de ibrutinib a bendamustina y rituximab (BR) y en combinacion con rituximab, ciclofosfamida, doxorubicina, vincristina y prednisona (R-CHOP) prolonga la supervivencia libre de evento (SLE) en comparación con solo BR o R-CHOP en sujetos con linfoma no-Hodgkin indolente (LNHi) previamente tratado.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare treatment groups in terms of the following:
    ? overall survival (OS)
    ? complete response rate (CR)
    ? overall response rate ORR (CR+PR)
    ? duration of response (DOR)
    ? patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
    ? safety of ibrutinib when combined with BR or R-CHOP
    Los objetivos secundarios consisten en comparar los siguientes parámetros entre los grupos de tratamiento:
    ?supervivencia global (SG)
    ?tasa de respuestas completas (RC)
    ?tasa de respuestas globales (TRG, RC+RP)
    ?duración de la respuesta (DR)
    ?síntomas y problemas del linfoma comunicados por el paciente, determinados mediante la subescala Lym de la Evaluación funcional del tratamiento del cáncer-Linfoma (FACT-Lym).
    ?seguridad del ibrutinib cuando se combina con BR o con R-CHOP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma
    - At least 1 prior treatment with a CD20 antibody combination chemotherapy regimen
    - Disease that has relapsed or was refractory after prior chemoimmunotherapy
    - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
    - Eastern Cooperative Oncology Group performance status grade 0 or 1
    - Laboratory values within protocol-defined parameters
    - Agrees to protocol-defined use of effective contraception
    - Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
    - Women of childbearing potential must have a negative serum or urine
    pregnancy test at screening
    -Diagnóstico de LNHel de linfocitos B con confirmación histológica, cuyo subtipo histológico esté limitado a linfoma folicular o linfoma de la zona marginal
    -Como mínimo un tratamiento previo basado en una pauta de quimioterapia combinada con un anticuerpo anti-CD20
    -Enfermedad que haya recaido o que fuera resistente después de la quimioinmunoterapia anterior
    -Al menos un foco mensurable de enfermedad según los Criterios revisados de respuesta en el linfoma maligno (Cheson 2007)
    -Estado funcional del Eastern Cooperative Oncology Group de 0 o 1.
    -Los valores hematológicos deben estar dentro de los límites definidos en el protocolo.
    -Comprometerse a usar metodos anticonceptivos eficades definidos en el protocolo.
    -Los varones también deberán comprometerse a no donar semen durante el estudio después de la última dosis de bendamustina, 12 meses después de la última dosis de rituximab o 3 meses después de la última dosis de la medicación del estudio, lo que suceda más tarde.
    -Las mujeres en edad fértil deben obtener un resultado negativo en una prueba de embarazo en suero u orina en el momento de la selección.
    E.4Principal exclusion criteria
    -Prior treatment according to protocol-defined criteria
    -Unable to receive background chemotherapy based on prior treatment history and cardiac function
    -Known central nervous system lymphoma
    -Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
    -History of stroke or intracranial hemorrhage within 6 months prior to randomization
    -Requires anticoagulation with warfarin or equivalent Vitamin K antagonists or treatment with strong CYP3A4/5 inhibitors
    -Clinically significant cardiovascular disease
    -Known history of human immunodeficiency virus or active infection with hepatitis C or B 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 participant?s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
    -Women who are pregnant or breastfeeding
    -Tratamiento previo de acuerdo a los criterios definidos en el Protocolo
    - Incapacidad para recibir quimioterapia de base debido al tratamiento previo y a la función cardíaca
    -Linfoma del SNC conocido.
    -Diagnóstico o tratamiento de un tumor maligno distinto del LNHel
    - Antecedentes de ictus o de hemorragia intracraneal en los 6 meses anteriores a la aleatorización
    - Necesidad de anticoagulación con warfarina o antagonistas de la vitamina K equivalentes o de de tratamiento con inhibidores potentes de la CYP3A4/5
    - Enfermedades cardiovasculares clínicamente importantes
    - Cualquier enfermedad, proceso médico o disfunción orgánica potencialmente mortal que, en opinión del investigador, pueda comprometer la seguridad del sujeto, interferir en la absorción o el metabolismo de las cápsulas de ibrutinib o suponer un riesgo excesivo para los resultados del estudio.
    -Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 7 years after the first participant is randomized
    Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    E.5.2Secondary end point(s)
    Overall survival
    1/ Overall survival
    2/ Complete response rate
    3/ Overall response rate
    4/ Duration of response
    5/ Participants with change in patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
    6/ Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
    Supervivencia global.
    1/Supervivencia global
    2/Tasa de respuesta completa
    3/Tasa de respuesta global
    4/Duración de la respuesta
    5/ Pacientes que informen de cambios en los sintomas del linfoma determinados mediante la subescala Lym de la Evaluación funcional del tratamiento del cáncer-Linfoma (FACT-Lym).
    6/Número de participantes afectados por eventos adversos segun los órganos y sistemas MedDRA (SOC) y el término preferido (PT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ Up to approximately 7 years after the first participant is randomized
    2/ Up to approximately 7 years after the first participant is randomized
    3/ Up to approximately 7 years after the first participant is randomized
    4/ Up to approximately 7 years after the first participant is randomized
    5/ Up to approximately 7 years after the first participant is randomized
    6/ Up to 30 days after the last dose of study medication
    1/ Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    2/ Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    3/ Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    4/ Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    5/ Hasta aproximadamente 7 años despues de que el primer participante sea randomizado.
    6/ Hasta 30 dias despues de la ultima dosis de la medicacion del estudio.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis
    Analisis de biomarcadores
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Belgium
    Brazil
    China
    France
    Germany
    Israel
    Italy
    Japan
    Poland
    Russian Federation
    Ukraine
    Korea, Republic of
    Spain
    Sweden
    Turkey
    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
    Per protocol, the end of the trial is defined as the time when 50% of subjects have died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 400
    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)
    Subjects will receive standard treatment, as determined by the treating physician. Information about their general heath status and survival follow up will continue to be collected for the trial
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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