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    Summary
    EudraCT Number:2017-003256-22
    Sponsor's Protocol Code Number:UKM17_0017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003256-22
    A.3Full title of the trial
    Ibrutinib and Standard Immuno-Chemotherapy (R-CHOEP-14) In Younger, High-Risk Patients with Diffuse Large B-Cell Lymphoma
    Ibrutinib und Standard-Immunochemotherapie (R-CHOEP-14) in jungen Hochrisiko- Patienten mit diffusem großzelligem B-Zell-Lymphom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ibrutinib and Standard Immuno-Chemotherapy (R-CHOEP-14) In Younger, High-Risk Patients with Diffuse Large B-Cell Lymphoma
    Ibrutinib und Standard-Immunochemotherapie (R-CHOEP-14) in jungen Hochrisiko- Patienten mit diffusem großzelligem B-Zell-Lymphom
    A.3.2Name or abbreviated title of the trial where available
    R-CHOEP-brut
    R-CHOEP-brut
    A.4.1Sponsor's protocol code numberUKM17_0017
    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 SponsorUniversitätsklinikum Münster
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Münster
    B.5.2Functional name of contact pointCentral study office
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Schweitzer-Campus 1, Gebäude A1
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+492518345375
    B.5.6E-mailBirte.Friedrichs@ukmuenster.de
    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 Yes
    D.2.1.1.1Trade name IMBRUVICA 140 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    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.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    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
    diffuse large B-cell lymphoma
    diffuses großzelliges B-Zell-Lymphom
    E.1.1.1Medical condition in easily understood language
    malignant disease of the lymphatic system
    bösartige Erkrankung des lymphatischen Systems
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to estimate the 2-year progression-free survival (PFS) achieved with ibrutinib in combination with immunochemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisolone (R-CHOEP) in newly diagnosed, younger patients (age 18-60 years) with diffuse large B-cell lymphoma (DLBCL) and age-adjusted International Prognostic Index (aaIPI) 2 or 3.
    Das primäre Ziel ist die Abschätzung des mit Ibrutinib in Kombination mit der Immunochemotherapie mit Rituximab, Cyclophosphamid, Doxorubicin, Vincristin, Etoposid und Prednisolon (R-CHOEP) erreichten 2-Jahres-progressionsfreien Überlebens (PFS) bei neu diagnostizierten, jüngeren Patienten (18-60 Jahre) mit einem diffusen großzelligen B-Zell-Lymphom (DLBCL) und einem altersadjustierten internationalen Prognose-Index (aaIPI) von 2 oder 3.
    E.2.2Secondary objectives of the trial
    The secondary objectives for efficacy are to evaluate overall survival (OS), event-free survival (EFS), rate of complete remission (CR), rate of partial remission (PR), overall response rate (ORR) (CR+PR), progression rate, relapse rate and the duration of response.

    Other secondary objectives of the trial are to assess the
    • rate of treatment-related deaths,
    • feasibility, safety, toxicity, and protocol adherence of ibrutinib when combined with R-CHOEP and
    • outcome according to biological parameters of the tumor.

    A preplanned additional analysis is to compare patients from this study with patients from the previous R-MegaCHOEP phase III trial (Schmitz et al., Lancet Oncol 2012).
    Die sekundären Zielkriterien der Wirksamkeit sind, das Gesamtüberleben, das ereignisfreie Überleben, die Remissionsrate (komplett), die Remissionsrate (partiell), die Remissionsrate (gesamt), die Progressionsrate, die Rezidivrate und die Dauer des Ansprechens zu beurteilen.

    Weitere Ziele der Studie sind,
    • die Rate der behandlungsbedingten Todesfälle,
    • Machbarkeit, Sicherheit, Toxizität und Protokolleinhaltung von Ibrutinib kombiniert mit R-CHOEP und
    • den Ausgang entsprechend biologischer Parameter des Tumors zu beurteilen.

    Eine vorher geplante zusätzliche Analyse ist, die Patienten aus dieser Studie mit Patienten aus der vorherigen R-MegaCHOEP phase III-Studie zu vergleichen (Schmitz et al., Lancet Oncol 2012).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
    2. Age between 18-60 years
    3. Risk score 2 or 3 according to aaIPI
    4. Histology: Primary diagnosis of
    - DLBCL (NOS) or
    - High-grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements or
    - High-grade B-cell lymphoma, NOS
    5. Performance status: ECOG 0-3
    6. Stage: all stages according Ann Arbor
    7. ANC: > 1000 cells/microliter (independent of growth factor support)
    8. Platelet count ≥ 100.000/mm3 or ≥ 50.000/mm3 if bone marrow involvement independent of transfusion support in either situation.
    9. ALT and AST: < 3 x ULN
    10. Total Bilirubin: < 1.5 x ULN
    11. Serum Creatinine: < 2 x ULN or estimated GFR (GFR [Cockcroft-Gault]) ≥ 40 ml/min
    12. Women of childbearing potential and men who are sexually active must be practising a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For male subjects, these restrictions apply for 6 months after last dose of study drug. For female subjects, they apply for 12 months after last dose of study drug.
    13. Women of childbearing potential must have negative serum or urine beta-human chorionic gonadotropin pregnancy test at screening. Women who are pregnant or breast-feeding are ineligible for this study.
    14. Willing/ able to adhere to the prohibitions and restrictions specified in this protocol.
    1. Schriftlich unterzeichnete Einwilligung
    2. Alter zwischen 18-60 Jahren
    3. Risiko-Score von 2 oder 3 entsprechend aaIPI
    4. Histologie: Primärdiagnose eines
    - DLBCL (NOS) oder
    - „high-Grade“ B-Zell-Lymphoms mit MYC- und BCL2- und/oder BCL6-Umlagerung oder
    - „high-Grade“ B-Zell-Lymphoms, NOS B-Zell-Lymphoms, NOS
    5. Performance-Status: ECOG 0-3
    6. Stadium: Alle Stadien entsprechend Ann Arbor
    7. Absolute Neutrophilenzahl: > 1000 Zellen/Mikroliter (unabhängig von Wachstumsfaktor-Unterstützung)
    8. Thrombozytenzahl ≥ 100.000/mm3 oder ≥ 50.000/mm3 bei Knochenmarkbeteiligung unabhängig von einer Transfusionsunterstützung.
    9. ALT und AST: < 3 x ULN
    10. Bilirubin (Gesamt): < 1.5 x ULN
    11. Serum Kreatinin: < 2 x ULN oder geschätzter GFR (GFR [Cockcroft-Gault]) ≥ 40 ml/min
    12. Frauen, die gebärfähig sind, und Männer, die sexuell aktiv sind, müssen während und nach der Studie konsequent eine hochwirksame Methode der Geburtenkontrolle praktizieren. Männer müssen sich damit einverstanden erklären, während und nach der Studie keine Spermien zu spenden. Für männliche Probanden, gilt diese Einschränkungen für 6 Monate nach der letzten Dosis der Studie Medikament. Für weibliche Probanden, gilt sie für 12 Monate nach der letzten Dosis der Studienmedikament.
    13. Frauen, die gebärfähig sind, müssen einen negativen Serum- oder Urin-beta-HCG-Schwangerschafttest beim Screening aufweisen. Schwangere oder stillende Frauen sind in dieser Studie nicht teilnahmeberechtigt.
    14. Wille/Fähigkeit zur Einhaltung der in diesem Protokoll festgelegten Verbote und Einschränkungen.
    E.4Principal exclusion criteria
    1. Vaccinated with live, attenuated vaccines within 4 weeks of inclusion.
    2. Major surgery within 4 weeks of inclusion.
    3. Any prior lymphoma-directed therapy (except pre-phase treatment).
    4. Known central nervous system involvement.
    5. Diagnosed or treated for malignancy other than DLBCL, in particular any other (indolent) lymphoma.
    6. 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 or 4 cardiac disease as defined by the New York Heart Association Functional classification.
    7. Bone marrow involvement > 25%
    8. History of stroke or intracranial hemorrhage within six months of inclusion.
    9. Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
    10. Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring IV antibiotics.
    11. Requires treatment with strong CYP3A inhibitors.
    12. Use of preparations containing St. John’s Wort.
    13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
    14. Concurrent treatment with other investigational agent or X-ray therapy.
    15. Previous chemo- or radiotherapy for any other malignancy, in particular indolent lymphoma.
    16. Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the study protocol.
    17. Participation in another interventional clinical trial during this trial. There may be exceptions at the discretion of the coordinating investigator.
    1. Impfung mit Lebendimpfstoffen innerhalb von 4 Wochen nach Aufnahme in die Studie.
    2. Größere Operation innerhalb von 4 Wochen nach Aufnahme in die Studie.
    3. Jede vorherige lymphombezogene Therapie (außer Vorphasen-Therapie).
    4. Bekannte Beteiligung des Zentralnervensystems.
    5. diagnostizierte oder behandelte Malignome außer DLBCL, insbesondere gegen jedes andere (indolente) Lymphom.
    6. Klinisch bedeutsame Herz-Kreislauf-Erkrankungen wie unkontrollierte oder symptomatische Herzrhythmusstörungen, Herzinsuffizienz oder Myokardinfarkt innerhalb von 6 Monaten nach dem Screening oder jede andere Herzkrankheit der Klasse 3 oder 4 (New York Heart Association).
    7. Knochenmarkbeteiligung > 25%.
    8. Vorgeschichte eines Schlaganfalls oder einer intrakraniellen Blutung innerhalb von sechs Monaten nach Aufnahme in die Studie.
    9. notwendige Antikoagulation mit Warfarin oder gleichwertigem Vitamin K-Antagonisten.
    10. Infektion mit dem humanen Immunschwächevirus (HIV), Hepatitis C, eine aktive Virusinfektion mit Hepatitis B oder jede unkontrollierte, aktive systemische Infektion, die IV-Antibiotika erfordert.
    11. Behandlung mit starken CYP3A-Inhibitoren.
    12. Verwendung von Präparaten, die Johanniskraut enthalten.
    13. Jede lebensbedrohliche Erkrankung, Krankheit oder Störung des Organsystems, die nach Ansicht des Prüfers die Sicherheit des Prüfungsteilnehmers gefährdet, die Absorption oder den Metabolismus von Ibrutinib-Kapseln beeinträchtigen oder die Studienergebnisse unangemessen gefährden könnte.
    14. Gleichzeitige Behandlung mit anderen Prüfpräparaten oder eine Röntgentherapie.
    15. Frühere Chemo- oder Strahlentherapie bei allen anderen bösartigen Erkrankungen, insbesondere indolenten Lymphomen.
    16. Jede psychologische, kognitive, familiäre, soziologische oder geographische Situation, die nach Ansicht des Prüfarztes die Fähigkeit des Patienten beeinträchtigt, die Patienteninformation zu verstehen, seine Einwilligung zu erteilen oder das Studienprotokoll einzuhalten.
    17. Teilnahme an einer weiteren interventionellen klinischen Studie während dieser Studie. Ausnahmen können nach Ermessen des Leiters der klinischen Prüfung möglich sein.
    E.5 End points
    E.5.1Primary end point(s)
    2-year PFS with 95% confidence intervals (CI) in 40 patients without CNS disease.
    2-jähriges progressionsfreie Überleben mit einem 95% Konfidenzintervall bei 40 Patienten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the course of therapy and follow-up.
    Im Verlauf der Therapie und in der Nachbeobachtung.
    E.5.2Secondary end point(s)
    Secondary endpoints for efficacy:
    OS, EFS, CR rate, PR rate, ORR, progression rate, relapse rate, duration of response.

    Other secondary endpoints:
    AEs, SAEs, treatment-related deaths, Secondary malignancies,
    Number and duration of therapy cycles, Cumulative doses of cyclophosphamide, doxorubicin, vincristine, etoposide, rituximab and ibrutinib, outcome according to biological parameters.

    Furthermore, PFS achieved in this trial will be compared to historical controls (DLBCL patients with aaIPI 2 or 3 treated with R-CHOEP-14 within R-MegaCHOEP phase III trial; Schmitz et al. Lancet Oncology 2012).
    Sekundäre Endpunkte der Wirksamkeit sind:
    Gesamtüberleben, ereignisfreies Überleben, Remissionsrate (komplett), Remissionsrate (partiell), Remissionsrate (gesamt), Progressionsrate, Rezidivrate und die Dauer des Ansprechens

    Andere sekundäre Endpunkte sind: AEs, SAEs, behandlungsbedingte Todesfälle, Sekundäre Malignome, Anzahl und Dauer der Therapiezyklen, Kumulierte Dosis von Cyclophosphamid, Doxorubicin, Vincristin, Etoposid, Rituximab und Ibrutinib, Ausgang entsprechend biologischer Parameter des Tumors.

    Darüber hinaus soll das progressionsfreie Überleben aus dieser Studie verglichen werden mit dem progressionsfreien Überleben der vorherigen R-MegaCHOEP phase III-Studie (Schmitz et al., Lancet Oncol 2012).
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the course of therapy and follow-up.
    Im Verlauf der Therapie und in der Nachbeobachtung.
    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 No
    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 No
    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 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The study will end 2 years after the last patient enrolled in the study.
    Die Studie endet 2 Jahre nach dem letzten Patienten, der in die Studie aufgenommen wurde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state40
    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)
    Patients in complete or partial remission after all study treatment do not receive any other therapy. Patients who need additional therapy after completion of the entire treatment according to the protocol should be given salvage therapy, whenever possible within a prospective trial.
    Patienten in vollständiger oder partieller Remission nach allen Studienbehandlungen erhalten keine andere Therapie. Patienten, die nach Abschluss der gesamten Behandlung entsprechend dem Protokoll eine zusätzliche Therapie benötigen, sollten nach Möglichkeit im Rahmen einer prospektiven Studie eine Salvage-Therapie erhalten.
    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 Decision2018-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-23
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