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    EudraCT Number:2012-004097-26
    Sponsor's Protocol Code Number:PCI-32765FLR2002
    National Competent Authority:Italy - Italian Medicines Agency
    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 ConcernedItaly - Italian Medicines Agency
    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
    Uno studio di fase II a braccio singolo, multicentrico, in aperto su PCI-32765 (ibrutinib) in soggetti con linfoma follicolare refrattario
    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
    Uno studio su PCI-32765 (ibrutinib)in pazienti con linfoma follicolare refrattario
    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.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 CILAG SPA
    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/ cityLleiden
    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 follicolare
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Tumore del sangue
    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 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 No
    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
    L'obiettivo principale dello studio è valutare il tasso di risposta globale di PCI-32765, secondo la valutazione del Comitato di revisione indipendente (IRC), in soggetti con linfoma follicolare resistente alla chemio-immunoterapia.
    E.2.2Secondary objectives of the trial
     Evaluate the duration of response  Evaluate the safety
    Valutazione della durata della risposta Valutazione della sicurezza di PCI327656
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation 2 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) 3 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 4 At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma 5 Eastern Cooperative Oncology Group performance status grade 0 or 1 6 Hematology and biochemical laboratory values must be within protocol defined parameters within 7 days prior to enrollment 7 Agrees to protocol-defined use of effective contraception 8 Women of childbearing potential must have a negative serum or urine pregnancy test at screening
    1. Prova istologica di linfoma follicolare di grado 1, 2 o 3a senza evidenza clinica o patologica di trasformazione. 2. Precedente trattamento con almeno due linee di terapia precedenti con almeno un precedente regime chemioterapico contenente rituximab; ultima linea di terapia precedente inclusiva di un regime chemioterapico contenente un anticorpo monoclonale anti-CD20 (per linee di terapia distinte si intendono regimi diversi intervallati dalla progressione della malattia, dalla malattia refrattaria o da una recidiva). 3. Malattia resistente all'ultima terapia precedente, definita come progressione della malattia durante o entro 12 mesi dall'ultima dose di un regime chemioterapico comprendente un anticorpo anti-CD20. 4. Almeno 1 sede misurabile della malattia secondo i criteri di risposta revisionati per il linfoma maligno secondo il International Working Group 5. Stato di performance secondo Eastern Cooperative Oncology Group di grado 0 or 1 6. I valori ematologici e biochimici devono essere compresi entro i limiti definiti dal protocollo ed entro i 7 giorni precedenti all'arruolamento. 7. Accettazione di misure contraccettive altamente efficaci come da protocollo. 8. Le donne in età fertile devono presentare un test di gravidanza sul siero o sulle urine negativo allo screening.
    E.4Principal exclusion criteria
    1 Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxinimmunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug 2 Prior treatment with PCI-32765, other Bruton's tyrosine kinase inhibitors, or phosphoinositide 3-kinase delta inhibitors 3 Concurrent enrollment in another therapeutic investigational clinical treatment study 4 Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed) 5 Known central nervous system lymphoma 6 History of prior malignancy except: a) malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated cervical carcinoma in situ wit hout evidence of disease) 7 History of stroke or intracranial hemorrhage within 6 months prior to enrollment 8 Requires anticoagulation with warfarin or equivalent vitamin K antagonists 9 Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors 10 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 11 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 12 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. Precedente trattamento con nitrosuree nelle 6 settimane precedenti, chemioterapia nelle 3 settimane precedenti, immunoterapia antitumorale nelle 4 settimane precedenti, terapia con radioimmunoconiugati o immunotossine nelle 10 settimane precedenti, radioterapia o altri agenti sperimentali nelle 3 settimane precedenti o intervento chirurgico di rilievo nelle 4 settimane precedenti alla prima somministrazione del farmaco dello studio. 2. Precedente trattamento con PCI-32765, altri inibitori di BTK o inibitori di PI3K delta. 3. Arruolamento contemporaneo in un altro studio clinico sperimentale terapeutico. 4. Precedente trapianto allogenico di cellule staminali ematopoietiche (è consentito un precedente trapianto autologo di cellule staminali ematopoietiche). 5. Linfoma noto del sistema nervoso centrale. 6. Precedente storia di neoplasia, ad eccezione di: a. neoplasia trattata con intento curativo e assenza di malattia attiva nota negli ultimi 3 anni prima dell'arruolamento; b. cancro della pelle diverso dal melanoma o lentigo maligna adeguatamente trattati senza evidenza di malattia; c. carcinoma cervicale in situ adeguatamente trattato senza evidenza di malattia. 7. Anamnesi di ictus o emorragia intracranica entro i 6 mesi precedenti all'arruolamento. 8. Necessità di terapia anticoagulante con warfarin o antagonisti della vitamina K equivalenti 9. Necessità di trattamento con forti inibitori del citocromo P450 (CYP)3A4/5. 10. Malattia cardiovascolare clinicamente significativa, come aritmie sintomatiche o non controllate, insufficienza cardiaca congestizia o infarto del miocardio nei 6 mesi precedenti allo screening, o altra malattia cardiaca di classe 3 (moderata) o classe 4 (grave) secondo la definizione della New York Heart Association Functional Classification. 11. Anamnesi nota di infezione da virus dell'immunodeficienza umana (HIV) o epatite C o infezione attiva da virus dell'epatite B o qualsiasi altra infezione sistemica attiva non controllata che richieda la somministrazione di antibiotici per via endovenosa.
    12. Donne in gravidanza o allattamento. 13 Qualsiasi patologia, condizione medica o disfunzione degli organi potenzialmente fatale che, secondo il giudizio dello sperimentatore, potrebbe compromettere la sicurezza del soggetto, interferire con l'assorbimento o il metabolismo delle capsule di PCI-32765 o mettere inutilmente a rischio i risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate
    Tasso di risposta generale
    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)
    Ogni 12 settimane durante i primi 24 mesi, poi ogni 24 settimane fino a progressione di malattia (fino a 2 anni dopo l'ultimo paziente arruolato)
    E.5.2Secondary end point(s)
    Duration of response
    Durata della risposta
    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)
    Ogni 12 settimane durante i primi 24 mesi, poi ogni 24 settimane fino a progressione di malattia (fino a 2 anni dopo l'ultimo paziente arruolato)
    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
    Analisi dei biomarcatori
    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) 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 concerned7
    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 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 years0
    E.8.9.1In the Member State concerned months43
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months43
    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.1.1Number of subjects for this age range: 0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    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.
    I pazienti senza progressione potranno accedere ad uno studio di roll over per continuare il trattamento. I pazienti con progressione saranno trattati secondo lo standard di cura
    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 Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-18
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