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    Summary
    EudraCT Number:2012-000711-88
    Sponsor's Protocol Code Number:PCI-32765MCL2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-12
    Trial results View 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 number2012-000711-88
    A.3Full title of the trial
    A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton' s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Mantle Cell Lymphoma Who Progress after Bortezomib Therapy.
    Estudio fase 2, multicéntrico, de un solo brazo de tratamiento para evaluar la eficacia y seguridad del inhibidor de la Tirosina Quinasa de Bruton (Btk), Ibrutinib, en monoterapia, en sujetos con Linfoma de Células del Manto que progresan después de la terapia con Bortezomib.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress after Bortezomib Therapy.
    Estudio para evaluar la eficacia y seguridad del Ibrutinib, en sujetos con Linfoma de Células del Manto que progresan después de la terapia con Bortezomib.
    A.4.1Sponsor's protocol code numberPCI-32765MCL2001
    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 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.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeJNJ-54179060
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mantle Cell Lymphoma
    Linforma de Células del Manto
    E.1.1.1Medical condition in easily understood language
    Mantle Cell Lymphoma
    Linforma de Células del Manto
    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 PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    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
    The primary objective of the study is to evaluate the overall response rate of ibrutinib, as assessed by the Independent Review Committee (IRC), in subjects with MCL who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.
    El objetivo principal de este estudio consiste en evaluar la TRG de ibrutinib, según lo evaluado por el comité de revisión independiente (CRI), en pacientes con LCM que han recibido al menos un régimen previo de quimioterapia con rituximab y que han presentado progresión después de un tratamiento con bortezomib.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    -To evaluate the duration of response
    -To evaluate progression-free survival (PFS)
    -To evaluate overall survival
    -To evaluate the safety of ibrutinib
    -To characterize the pharmacokinetics of ibrutinib after oral dosing
    -To explore the potential relationships between ibrutinib metrics of exposure with relevant clinical or biomarker information
    -To evaluate patient-reported outcomes (PROs) utilizing the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and EuroQol (EQ-5D)
    -To identify biomarkers that alter B-cell receptor (BCR) signaling or activate alternative signaling pathways and to explore their association with response to ibrutinib
    Los objetivos secundarios son:
    -Evaluar la duración de la respuesta.
    -Evaluar la supervivencia sin progresión (SSP).
    -Evaluar la supervivencia global.
    -Evaluar la seguridad de ibrutinib.
    -Definir la farmacocinética de ibrutinib tras su administración oral.
    -Investigar posibles relaciones entre la cantidad de exposición a ibrutinib e información clínica o de biomarcadores relevante.
    -Evaluar resultados comunicados por los pacientes (PRO) mediante los cuestionarios de Evaluación funcional del tratamiento contra el cáncer-Linfoma (FACT-Lym) y EuroQol (EQ-5D).
    -Identificar biomarcadores que alteran la transmisión de señales del receptor de los linfocitos B (RLB) o activan vías de señalización alternativas e investigar su relación con la respuesta a ibrutinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of confirmed mantle cell lymphoma (MCL) with at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.
    - Must have received at least 1prior rituximab-containing chemotherapy regimen, but no more than 5 prior regimens.
    - Must have received at least 2 cycles of bortezomib therapy (single-agent or in combination) and have documented progressive
    disease during or after bortezomib therapy
    - Eastern Cooperative Oncology Group performance status score 0, 1, or 2.
    - Hematology and biochemical values within protocol-defined parameters.
    1.Tener 18 años o más de edad.
    2.Tener un diagnóstico de LCM confirmado por el laboratorio central antes de la inclusión
    3.Haber recibido al menos un régimen previo de quimioterapia con rituximab.
    4.Haber recibido al menos 2 ciclos de tratamiento con bortezomib (en monoterapia o en combinación) y haber presentado progresión de la enfermedad documentada durante o después del tratamiento con bortezomib.
    5.Tener al menos un sitio medible de enfermedad según los Criterios revisados de respuesta en el linfoma maligno (es decir, el sitio de enfermedad debe ser > 1,5 cm en el eje mayor con independencia de la medición del eje menor o > 1,0 cm en el eje menor con independencia de la medición del eje mayor y claramente medible en dos dimensiones perpendiculares).
    6.Tener un estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2.
    7.Tener unos valores hematológicos dentro de los límites siguientes:
    a. Recuento absoluto de neutrófilos >= 750/mm3 independiente del apoyo con factores de crecimiento.
    b. Recuento de plaquetas >= 50.000/mm3 independiente del apoyo con transfusiones.
    8. Tener unos valores bioquímicos dentro de los límites siguientes:
    a. Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) <= 2,5 veces el límite superior de la normalidad (LSN).
    b. Bilirrubina total <= 1,5 veces el LSN (a menos que la elevación de la bilirrubina sea consecuencia de un síndrome de Gilbert o de origen no hepático).
    c. Creatinina sérica <= 2 veces el LSN o filtración glomerular estimada (FGe [Crockcoft-Gault]) >= 30 ml/min
    9. Las mujeres en edad fértil y los varones sexualmente activos deberán utilizar un método anticonceptivo muy eficaz durante y después del estudio (1 mes en las mujeres y 3 meses en los varones) con arreglo a la normativa local sobre la utilización de métodos anticonceptivos por los pacientes que participan en ensayos clínicos. Los varones no podrán donar semen durante el estudio ni en los tres meses siguientes a la toma de la última dosis del fármaco del estudio.
    10. Las mujeres en edad fértil deberán dar un resultado negativo en una prueba de embarazo en suero (gonadotropina coriónica humana B) u orina en el momento de la selección.
    11. Los pacientes (o sus representantes legales) deberán firmar un documento de consentimiento informado que indique que entienden el objetivo del estudio y los procedimientos que exige y que están dispuestos a participar en él.
    E.4Principal exclusion criteria
    - Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other
    investigational agents within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
    - Prior treatment with ibrutinib or other Bruton´s tyrosine kinase inhibitors.
    - More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval.
    - 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 the first dose of study drug and felt to be at low risk for recurrence by the treating physician, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease.
    - History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
    - Requires anticoagulation with warfarin.
    - Requires treatment with strong CYP3A4/5 or CYP2D6 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.
    - Known history of human immunodeficiency virus or active infection with hepatitis C virus or hepatitis B virus or any
    uncontrolled active systemic infection.
    - 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.
    1. Hayan recibido quimioterapia en las 3 semanas, nitrosoureas en las 6 semanas, anticuerpos terapéuticos contra el cáncer en las 4 semanas, inmunoconjugados con productos radiactivos o toxinas en las 10 semanas, radioterapia u otros fármacos en investigación en las 3 semanas o una intervención de cirugía mayor en las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    2. Hayan recibido tratamiento previo con ibrutinib u otros inhibidores de la BTK.
    3. Hayan recibido más de 5 líneas previas de tratamiento (se definen líneas de tratamiento separadas como aquellos tratamientos en monoterapia o combinados separados por progresión de la enfermedad o por un intervalo sin tratamiento > 6 meses.
    4. Presenten un linfoma del sistema nervioso central (SNC) conocido.
    5. Hayan sido diagnosticados o tratados por neoplasias malignas distintas del LCM, excepto:
    a. Neoplasia maligna tratada con fines curativos y ausencia de enfermedad activa conocida durante >= 3 años antes de la primera dosis del fármaco del estudio y que el médico responsable del tratamiento considere de bajo riesgo de recidiva.
    b. Cáncer de piel distinto del melanoma o lentigo maligno tratado adecuadamente sin indicios de enfermedad.
    c. Carcinoma in situ de cuello uterino tratado adecuadamente sin indicios de enfermedad.
    6. Presenten antecedentes de ictus o hemorragia intracraneal en los 6 meses previos a la primera dosis del fármaco del estudio.
    7. Precisen anticoagulación con warfarina.
    8. Precisen tratamiento con inhibidores potentes de la enzima CYP3A4/5 o CYP2D6.
    9. Presenten enfermedades cardiovasculares clínicamente importantes como arritmias no controladas o sintomáticas, insuficiencia cardíaca congestiva o infarto de miocardio en los 6 meses previos a la selección, o cualquier cardiopatía en clase 3 (moderada) o 4 (grave) conforme a la clasificación funcional de la New York Heart Association.
    10. Presenten antecedentes de infección por el VIH o infección activa por el virus de la hepatitis C (VHC) o B (VHB) o cualquier infección sistémica activa no controlada.
    11. Sean mujeres embarazadas, en período de lactancia o que planean quedarse embarazadas en el mes posterior a la última dosis del fármaco del estudio o sean varones que planean engendrar un hijo mientras participen en este estudio o en los 3 meses siguientes a la última dosis del fármaco del estudio.
    12. Presenten cualquier enfermedad, proceso médico o disfunción orgánica potencialmente mortal que, en opinión del investigador, pudiera comprometer la seguridad del paciente, interferir en la absorción o el metabolismo de las cápsulas de ibrutinib o suponer un riesgo excesivo para los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the overall response rate
    El criterio de valoración principal es la tasa de respuesta global
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after the last patient is enrolled
    6 meses despues de la inclusion del ultimo paciente
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are
    1/ Overall survival rate
    2/ Progression-free survival rate
    3/ Mean change from baseline in the Lym subscale
    4/ Mean change from baseline in the EQ-5D-5L
    index
    5/ Mean plasma concentrations of ibrutinib
    6/ Maximum observed plasma concentration of
    ibrutinib
    7/ Minimum observed plasma concentration of
    ibrutinib
    8/ Area under the plasma concentration-time curve
    from time 0 to 24 hours of ibrutinib
    9/ The number of participants affected by an adverse event
    10/ Overall response rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ 6 months after the last patient is enrolled and 2
    years after the last patient is enrolled
    2/ 6 months after the last patient is enrolled and 2
    years after the last patient is enrolled
    3/ 6 months after the last patient is enrolled and 2
    years after the last patient is enrolled
    4/ 6 months after the last patient is enrolled and 2
    years after the last patient is enrolled
    5/ Up to Cycle 2, Day 21
    6/ Up to Cycle 2, Day 21
    7/ Up to Cycle 2, Day 21
    8/ Up to Cycle 2, Day 21
    9/ Up to 30 days after the last dose of study medication
    10/ 6 months after the last patient is enrolled and 2
    years after the last patient is enrolled
    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 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA28
    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
    Belgium
    France
    Israel
    Italy
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    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
    The primary analysis (primary end point is ORR) will be conducted 6 months after LPI, long term follow-up until 2 years after LPI at which point the study will end.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 110
    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 Decision2012-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-31
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