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    Summary
    EudraCT Number:2014-001363-12
    Sponsor's Protocol Code Number:TRIANGLE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001363-12
    A.3Full title of the trial
    Autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial
    Trapianto autologo dopo terapia di induzione con Rituximab/Ibrutinib/Ara-c nel linfoma mantellare generalizzato – uno studio randomizzato dell’European MCL Network
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Autologous transplantation after a Rituximab/Ibrutinib/Ara-c therapy in patients with generalized mantle cell lymphoma
    Trapianto autologo dopo terapia con Rituximab/Ibrutinib/Ara-c nei pazienti con linfoma mantellare generalizzato
    A.3.2Name or abbreviated title of the trial where available
    TRIANGLE
    TRIANGLE
    A.4.1Sponsor's protocol code numberTRIANGLE
    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 SponsorKLINIKUM DER UNIVERSITAET MUENCHEN
    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 Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München, Medizinische Klinik und Poliklinik III
    B.5.2Functional name of contact pointHead of Study Center for Hematology
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15 – 81377 Monaco - Germania
    B.5.3.2Town/ cityMuenchen
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number004989440074900
    B.5.5Fax number+4989440077900
    B.5.6E-mailstudyce@med.uni-muenchen.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 -CAPSULE RIGIDE -USO ORALE - FLACONE (HDPE) - 1 FLACONE (120 CAPSULE RIGIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/984 and EU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIMBRUVICA
    D.3.2Product code [IMP1]
    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.3.9.2Current sponsor codeIMP1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAntineoplastico
    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
    Generalized mantle cell lymphoma
    Linfoma mantellare generalizzato
    E.1.1.1Medical condition in easily understood language
    Patients with generalized mantle cell lymphoma
    Pazienti con linfoma mantellare generalizzato
    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 10026803
    E.1.2Term Mantle cell lymphoma stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10026805
    E.1.2Term Mantle cell lymphoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10026804
    E.1.2Term Mantle cell lymphoma stage III
    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
    To establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP+ibrutinib /R-DHAP followed by ASCT and ibrutinib maintenance (experimental arm A+I), and R-CHOP+ibrutinib /R-DHAP followed by ibrutinib maintenance (experimental arm I) as future standard based on the comparison of the investigator-assessed failure-free survival (FFS).
    Stabilire quale dei tre bracci di trattamento, R-CHOP/R-DHAP seguito da ASCT (braccio di controllo A), R-CHOP+ibrutinib/R-DHAP seguito da ASCT e mantenimento con ibrutinib (braccio sperimentale A+I) e R-CHOP+ibrutinib/R-DHAP seguito da mantenimento con ibrutinib (braccio sperimentale I) sarà il futuro trattamento standard, sulla base della sopravvivenza libera da fallimento (FFS) valutata dallo sperimentatore.
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of the three treatment arms in terms of secondary efficacy endpoints
    - To determine the safety and tolerability of ibrutinib during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints
    - Confrontare l’efficacia dei tre bracci di trattamento in termini di endpoint secondari di efficacia
    - Determinare la sicurezza e la tollerabilità dell’ibrutinib durante l’immunochemioterapia ed il mantenimento e confrontare il profilo di sicurezza dei tre bracci di trattamento in termini di endpoint secondari di tossicità.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Minimal residual disease evaluation (description included in the main study version 1.4 of 24 May 2018)

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Valutazione malattia minima residua (descrizione inclusa nel protocollo principale versione 1.4 del 24 maggio 2018)
    E.3Principal inclusion criteria
    ¿ Histologically confirmed diagnosis of MCL according to WHO classification
    ¿ Suitable for high-dose treatment including high-dose Ara-C
    ¿ Stage II-IV (Ann Arbor) • Age = 18 years and = 65 years
    ¿ Previously untreated MCL
    ¿ At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
    ¿ ECOG/WHO performance status = 2
    ¿ The following laboratory values at screening (unless related to MCL):
    - Absolute neutrophil count (ANC) ‡1000 cells/mL
    - Platelets ‡100,000 cells/mL
    - Transaminases (AST and ALT) £3 x upper limit of normal (ULN)
    - Total bilirubin £2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome])
    - Creatinine £2 mg/dL or calculated creatinine clearance ‡ 50 mL/min
    ¿ Written informed consent form according to ICH/EU GCP and national regulations
    ¿ Sexually active men and women of child-bearing potential must agree to use one of the highly effective contraceptive methods (combined oral contraceptives using two hormones, contraceptive implants, injectables, intrauterine devices, sterilized partner) together with one of the barrier methods (latex condoms, diaphragms, contraceptive caps) while on study; this should be maintained for 90 days after the last dose of study drug and 12 months after the last dose of rituximab
    • Diagnosi istologicamente confermata di MCL secondo il sistema di classificazione WHO
    • Idoneità per la terapia ad alte dosi contenente alte dosi di Ara-C
    • Stadio II-IV (Ann Arbor)
    • Età = 18 anni e = 65
    • MCL non precedentemente trattato
    • Almeno 1 lesione misurabile; in caso di sola infiltrazione midollare, la biopsia e l’aspirato del midollo saranno obbligatorie ad ogni fase di stadiazione
    • Performance status secondo ECOG/WHO = 2
    • I seguenti valori di laboratorio alla fase di screening (a meno che correlate al MCL):
    - Conta assoluta dei neutrofili (ANC) = 1000/µL
    - Piastrine = 100,000/µL
    - Transaminasi (AST and ALT) = 3 x limite superiore della norma (ULN)
    - Bilirubina totale = 2 x ULN (a meno che dovuta a Malattia di Meulengracht [Sindrome di Gilbert-Meulengracht])
    - Creatinina = 2 mg/dL o clearance della creatinina = 50 mL/min
    • Consenso informato scritto ottenuto secondo GCP ICH/EU e normative nazionali
    • Uomini sessualmente attivi e donne in età fertile devono acconsentire a utilizzare metodi contraccettivi altamente efficaci (contraccettivi orali combinati che utilizzano due ormoni, impianti contraccettivi, iniettabili, dispositivi intrauterini, partner sterilizzato) insieme a un metodo di barriera (preservativo, diaframma, cappuccio cervicale) nel corso dello studio e fino a 90 giorni dopo l’ultima dose del farmaco in studio e 12 mesi dopo l’ultima dose di rituximab
    E.4Principal exclusion criteria
    • Major surgery within 4 weeks prior to randomization.
    • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon).
    • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
    • Requires treatment with strong CYP3A4/5 inhibitors.
    • 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.
    • Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
    • Known CNS involvement of MCL
    • Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound of ibrutinib itself or to the excipients in its formulation)
    • Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
    • Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
    • Serious concomitant disease interfering with a regular therapy according to the study protocol:
    - Cardiac (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 or LVEF below LLN )
    - Pulmonary (e.g. chronic lung disease with hypoxemia)
    - Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus)
    - Renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinine clearance < 50 ml/min)
    - Impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2,0 mg/dl unless due to Morbus Meulengracht (Gilbert-Meulengracht-Syndrome)
    • Positive test results for chronic HBV infection (defined as positive HBsAg serology) (mandatory testing)
    • Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBSAb) after vaccination are eligible.
    • Positive test results for hepatitis C (mandatory hepatitis C virus [HCV] antibody serology testing). Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
    • Patients with known HIV positive infection (mandatory test)
    • Prior organ, bone marrow or peripheral blood stem cell transplantation
    • Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer or in situ uterine cervix cancer
    • Pregnancy or lactation
    • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
    • Subjects not able to give consent
    • Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
    • Participation in another clinical trial within 30 days before randomization in this study.
    • Chirurgia maggiore nei 28 giorni precedenti la randomizzazione
    • Trattamento anticoagulante con warfarin o antagonista competitivo della vitamina K (es. fenprocumone).
    • Storia di ictus o emorragia cerebrale nei 6 mesi precedenti la randomizzazione
    • Trattamento con potenti inibitori di CYP3A4/5
    • Qualsiasi malattia pericolosa per la vita, condizione medica o disfunzione d’organo che, a parere dello sperimentatore, potrebbe rappresentare un rischio per il paziente, interferire con l’assorbimento o il metabolismo dell’ibrutinib, o compromettere i risultati dello studio
    • Pazienti vaccinati con vaccini vivi attenuati nelle 4 settimane precedenti la randomizzazione
    • Coinvolgimento noto del sistema nervoso centrale (SNC)
    • Ipersensibilità clinicamente significativa (es. reazioni anafilattiche o anafilattoide all’ibrutinib o agli eccipienti presenti nella sua formulazione)
    • Nota ipersensibilità all'anticorpo umano antimurino (HAMA) e agli anticorpi murini
    • Precedentemente trattamento per il linfoma con radioterapia, farmaci citostatici, anticorpo anti-CD20 o interferone eccetto la terapia di prefase indicata dal protocollo
    • Malattia seria concomitante che può interferire con una regolare terapia così come previsto dal protocollo di studio:
    - Cardiaca (Malattia cardiovascolare clinicamente significativa quale aritmia incontrollata o sintomatica, insufficienza cardiaca congestizia o infarto miocardico entro 6 mesi dallo screening, o qualsiasi malattia cardiaca di Classe 3 (moderata) o 4 (severa) secondo la classificazione funzionale della New York Heart Association (NYHA) o la frazione di eiezione (LVEF) più bassa del limite inferiore del range di normalità (LLN)
    - Polmonare (es. malattia polmonare cronica con ipossia)
    - Endocrinologica (es. diabete mellito severo, non sufficientemente controllato)
    - Insufficienza renale (a meno che causata dal linfoma): creatinina > 2 volte il limite superiore normale o clearance della creatinina < 50 mL/min
    - Alterazione della funzionalità epatica (a meno che causata dal linfoma): transaminasi > 3 volte il limite superiore normale o bilirubina > 2,0 mg/dl (tranne se dovuta a Morbo di Meulengracht [Sindrome di Gilbert-Meulengracht])
    • Pazienti con infezione cronica da HBV (intesa come sierologia positiva per HBsAg) (test mandatorio)
    • Pazienti con infezione HBV occulta o pregressa (HBsAg negativo e HBcAb totale positivo) e HBV DNA non rilevabile possono essere inclusi a condizione che siano disposti a sottoporsi a test mensili per la ricerca del DNA virale. Sono eleggibili per lo studio anche i pazienti con titolo anticorpale protettivo (HBsAb) acquisito dopo vaccinazione
    • Pazienti positivi alla ricerca degli anticorpi anti HCV nel siero (test mandatorio) sono eleggibili solo se negativa l’HCV RNA alla PCR
    • Pazienti con sierologia positiva per virus dell'immunodeficienza umana (HIV)
    • Precedente trapianto d’organo, midollo o cellule staminali da sangue periferico
    • Altri tumori maligni in atto o in anamnesi nei 3 anni precedenti ad eccezione di carcinoma cutaneo basocellulare o carcinoma in situ della cervice
    • Gravidanza o allattamento
    • Qualsiasi condizione psicologica, familiare, sociale o geografica potenzialmente in grado di ostacolare il rispetto del protocollo di studio e del programma di follow up
    • Soggetti incapaci di fornire il consenso informato
    • Soggetti privi di capacità legale che non sono in grado di comprendere la natura, lo scopo, il significato e le conseguenze di questo studio clinico
    • Partecipazione ad altri protocolli clinici nei 30 giorni precedenti la randomizzazione in questo studio
    E.5 End points
    E.5.1Primary end point(s)
    FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
    FFS definita come il tempo trascorso dalla randomizzazione fino al verificarsi di uno dei seguenti eventi: malattia stabile alla fine dell’immunochemioterapia, progressione, o decesso per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of immuno-chemotherapy, progressive disease, or death from any cause.
    Fine dell'immunoterapia, progressione o morte per qualsiasi causa.
    E.5.2Secondary end point(s)
    Overall Survival (OS); Overall response and complete remission rates; Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03); Cumulative incidence rates of SPMs.; PR to CR conversion rate; Progression-free survival (PFS)
    Sopravvivenza globale (OS); Risposta complessiva e tassi di remissione completa; Tassi di AEs, SAEs, and SUSARs (CTC-Version 4.03); Tassi di incidenza cumulativa di neoplasie secondarie; Tasso di conversione da PR a CR; Sopravvivenza libera da progressione (PFS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Regularly evaluated during the conduct of the study therefore there is no specific evaluation time; Midterm evaluation, at end of induction, 3 months after end of induction immunochemotherapy; During induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy.; Regularly evaluated during the conduct of the study therefore there is no specific evaluation time; During follow-up after end of induction; Regularly evaluated during the conduct of the study therefore there is no specific evaluation time
    Regolarmente valutato durante la conduzione dello studio quindi non esiste uno specifico tempo di rilevazione; Valutazione intermedia, alla fine dell'induzione, 3 mesi dopo la fine dell'induction immuno-chemotherapy; Durante l'immunochemioterapia di induzione e durante il follow up dopo la risposta all'immuno-chemioterapia; Regolarmente valutati durante la conduzione dello studio quindi non esiste uno specifico tempo di rilevazione; Durante il follow up dopo la fine dell'induzione; Regolarmente valutato durante la conduzione dello studio quindi non esiste uno specifico tempo di rilevazione
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Sei cicli alternati di R-CHOP/R-DHAP seguiti da trapianto autologo (ASCT)
    Six alternating courses of R-CHOP/RDHAP followed by ASCT
    E.8.2.4Number of treatment arms in the trial3
    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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA230
    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 Information not present in EudraCT
    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
    Croatia
    Czechia
    Denmark
    Finland
    Germany
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 820
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 870
    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 will be treated according to the local standard care.
    I pazienti saranno trattati secondo le cure standard locali.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Phase I/II platform e.V. of the European Mantle Cell Lymphoma Network, Klinikum der Universität München, Med. Klinik III
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Deutsche Studiengruppe Niedrig Maligne Lymphome e.V. (GLSG), Klinikum Großhadern, Medizinische Klinik
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Fondazione Italiana Linfomi ONLUS
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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