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    EudraCT Number:2012-004097-26
    Sponsor's Protocol Code Number:PCI-32765FLR2002
    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:2013-01-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-004097-26
    A.3Full title of the trial
    An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (ibrutinib) in Subjects with Refractory Follicular Lymphoma
    Estudio fase 2, abierto, multicéntrico, de un solo brazo de tratamiento de PCI-32765 (Ibrutinib) en sujetos con Linfoma Folicular refractario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of PCI-32765 (Ibrutinib) in Patients with Refractory Follicular Lymphoma
    Estudio de PCI-32765 (Ibrutinib) en pacientes con Linfoma Folicular refractario
    A.4.1Sponsor's protocol code numberPCI-32765FLR2002
    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.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.5.4Telephone number+31(0)71 524 21 66
    B.5.5Fax number+31(0)71 524 21 10
    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.3.9.3Other 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Follicular Lymphoma
    Linfoma Folicular
    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 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 the study is to evaluate the ORR of PCI-32765, as assessed by the Independent Review Committee (IRC), in subjects with chemoimmunotherapy-resistant FL
    El objetivo principal del estudio consiste en evaluar la TRG de PCI-32765, evaluada por un Comité de Revisión Independiente (CRI) en pacientes con LF resistente a la quimioinmunoterapia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    ? Evaluate the duration of response
    ? Evaluate the safety of PCI-32765
    Los objetivos secundarios son:
    ?Evaluar la duración de la respuesta
    ?Evaluar la seguridad de PCI 32765
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation
    ?Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease)
    ?Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of a CD20 antibody combination chemotherapy regimen
    ?At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma
    ?Eastern Cooperative Oncology Group performance status grade 0 or 1
    ?Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment
    ?Agrees to protocol-defined use of effective contraception
    ?Women of childbearing potential must have a negative serum or urine pregnancy test at screening
    1.18 años o más de edad.
    2.Confirmación histológica de LF de grados 1, 2, ó 3a en el diagnóstico inicial, sin signos clínicos o anatomopatológicos de transformación. En el apartado 9.2.2 se recogen los criterios de enfermedad.
    Si el informe del laboratorio local no está disponible, el diagnóstico debe ser confirmado por el laboratorio de anatomía patológica central según los criterios del apartado 9.2.2.
    3.El tratamiento previo consiste en todos los criterios siguientes:
    a.tratamiento previo con al menos 2 líneas previas de tratamiento,
    b.haber recibido al menos un régimen previo de quimioterapia combinada con rituximab,
    c.la última línea previa de tratamiento basada en un régimen de quimioterapia con un anticuerpo monoclonal anti CD20.
    Nota: Las líneas separadas de tratamiento se definen como regímenes diferentes que están separados por la progresión, la recaída o la resistencia de la enfermedad.
    4.Enfermedad resistente al último tratamiento previo, definida como progresión de la enfermedad durante o en los 12 meses siguientes a la última dosis de un régimen de quimioterapia combinada de anticuerpos anti CD20.
    5.Tener al menos un foco medible de enfermedad según los Criterios revisados de respuesta en el linfoma maligno4 (es decir, el foco 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 o 1.
    7.Valores hematológicos comprendidos entre los límites siguientes en los 7 días previos a la inclusión:
    a.Recuento absoluto de neutrófilos (RAN) ?750/mm3 independiente del apoyo con factores de crecimiento.
    b.Recuento de plaquetas independiente de las transfusiones ?75.000/mm3 (o ?50.000/mm3 si hay afectación de la médula ósea con linfoma).
    c.Concentración de hemoglobina ?8 g/dl, independiente del apoyo con transfusiones.
    8.Valores bioquímicos comprendidos entre los límites siguientes en los 7 días previos a la inclusión:
    a.Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ? 3 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. Para más detalles, véase el consentimiento informado.
    10.Las mujeres en edad fértil deben obtener un resultado negativo en una prueba de embarazo en suero (gonadotropina coriónica humana beta [? hCG]) u orina en el momento de la selección. No se permite que participen en este estudio las mujeres embarazadas o lactantes.
    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 nitrosoureas within 6 weeks, chemotherapy within 3 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 first dose of study drug
    ?Prior treatment with PCI-32765, other Bruton?s tyrosine kinase inhibitors, or phosphoinositide 3-kinase delta inhibitors
    ?Concurrent enrollment in another therapeutic investigational clinical treatment study
    ?Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed)
    ?Known central nervous system lymphoma
    ?History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment, 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 enrollment
    ?Requires anticoagulation with warfarin or equivalent vitamin K antagonists
    ?Requires treatment with strong cytochrome P450 (CYP)3A4/5 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 (HIV) or Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics
    ?Women who are pregnant or breastfeeding
    ?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 PCI-32765 capsules, or put the study outcomes at undue risk
    1.Hayan recibido nitrosoureas en las 6 semanas. quimioterapia en las 3 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.Tratamiento previo con PCI 32765, otros inhibidores de la BTK o inhibidores de la PI3K delta.
    3.Participación simultanea en otro ensayo clínico terapéutico de investigación.
    4.Haber recibido un trasplante previo de células progenitoras hematopoyéticas alogénicas. Se permite el trasplante previo autólogo de células progenitoras hematopoyéticas.
    5.Presenten un linfoma del sistema nervioso central conocido.
    6.Antecedentes de tumor maligno, excepto:
    a.Neoplasia maligna tratada con fines curativos y sin actividad conocida durante ? 3 años antes de la inclusión.
    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.
    7.Antecedentes de ictus o de hemorragia intracraneal en los 6 meses previos a la inclusión.
    8.Necesidad de anticoagulación con warfarina o antagonistas de la vitamina K equivalentes (por ejemplo, fenprocumona).
    9.Necesidad de tratamiento con inhibidores potentes del citocromo P450(CYP)3A4/5. 10.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.
    11.Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH) o de la hepatitis C, o hepatitis B activa o cualquier infección sistémica activa no controlada que precise antibióticos intravenosos (i.v.).
    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 PCI 32765 o suponer un riesgo excesivo para los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate
    Tasa de respuesta global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time frame = every 12 weeks during the first 24 months, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)
    Cada 12 semanas durante los primeros 24 meses, después cada 24 semanas hasta progresión de la enfermedad (hasta 2 años después del último paciente incluido)
    E.5.2Secondary end point(s)
    Duration of response
    Duración de la respuesta
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time frame = every 12 weeks during the first 24 months, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)
    Cada 12 semanas durante los primeros 24 meses, después cada 24 semanas hasta progresión de la enfermedad (hasta 2 años después del primer paciente incluido)
    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
    Análisis 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. 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Russian Federation
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months43
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months43
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    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)
    For those patients that have not progress a roll over study will be available for continued access to the study drug. Patient who have progressed will be treated according to Standard of Care for their country.
    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 Decision2013-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-18
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