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    EudraCT Number:2019-001573-89
    Sponsor's Protocol Code Number:D8220C00008
    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:2021-01-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001573-89
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia
    Studio di fase 3b, multicentrico, in aperto, a braccio singolo, su acalabrutinib (ACP-196) in soggetti affetti da leucemia linfocitica cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Acalabrutinib in patients with chronic lymphocytic leukemia
    Trattamento con Acalabrutinib in pazienti con leucemia linfocitica cronica
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD8220C00008
    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 SponsorASTRAZENECA AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018002369933
    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 nameAcalabrutinib
    D.3.2Product code [ACP-196]
    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 INNAcalabrutinib
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    D.3.9.3Other descriptive nameACP-196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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
    Chronic lymphocytic leukemia
    Leucemia linfocitica cronica
    E.1.1.1Medical condition in easily understood language
    Patients with chronic lymphocytic leukemia in need of treatment
    Pazienti con leucemia linfocitica cronica che hanno bisogno di trattamento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of acalabrutinib monotherapy in subjects with treatment-naive or relapsed/refractory chronic lymphocytic leukemia
    Valutare la sicurezza e la tollerabilità di acalabrutinib in monoterapia in soggetti con leucemia linfocitica cronica naïve al trattamento o recidivante/refrattaria
    E.2.2Secondary objectives of the trial
    To evaluate the investigator-assessed overall response rate, duration of response, and progression-free survival in subjects receiving acalabrutinib monotherapy;
    Valutare il tasso di risposta complessiva, la durata della risposta e la sopravvivenza libera da progressione determinati dallo sperimentatore nei soggetti che ricevono acalabrutinib in monoterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women >=18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place);
    2. Diagnosis of CLL that meets published diagnostic criteria:
    a. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing >=1 B-cell marker (CD19, CD20, and CD23) and CD5;
    b. Prolymphocytes may comprise <55% of blood lymphocytes;
    c. Presence of =5 × 10^9 B lymphocytes/L (5000/µL) in the peripheral blood (at any point since the initial diagnosis);
    3. Active disease as per at least 1 of the following IWCLL 2018 criteria:
    a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <10 g/dL) and/or thrombocytopenia (platelets <100,000/µL).
    b. Massive (i.e., >=6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
    c. Massive nodes (i.e., >=10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
    d. Progressive lymphocytosis with an increase of >50% over a 2-month period or a lymphocyte doubling time (LDT) of <6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte count obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In participants with initial blood lymphocyte counts of <30x109/L (30,000/µL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.
    e. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
    f. B-symptoms documented in the participants chart with supportive objective measures, as appropriate, defined as >=1 of the following disease-related symptoms or signs (please refer to protocol for related symptoms);
    4. Must meet 1 of the following criteria:
    a. Have received no prior therapy for treatment of CLL and meets 1 of the following criteria:
    i. A score of >6 on the Cumulative Illness Rating Scale (CIRS).
    ii. Creatinine clearance of 30 to 69 ml/min using the Cockcroft-Gault equation.
    b. Have previously received therapy for CLL and have either refractory or relapsed CLL.
    c. Have received prior BTKi therapy (i.e., defined as a participant who discontinued a BTKi for any reason except disease progression) for CLL.
    5. ECOG performance status of <=2;
    6. Female subjects of childbearing potential (i.e., not surgically sterile or postmenopausal) who are sexually active with a non-sterilized male partner must use =1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 2 days after the last dose of study treatment. Contraception measures
    and restrictions on sperm donation are not required for male subjects.
    7. Fluorescence in situ hybridization (FISH) results within 60 days before or during screening reflecting the presence or absence of del(17p), 13q del, 11q del, and trisomy of chromosome 12 along with the percentage of cells with the deletion, along with TP53 sequencing. Participants must also have molecular analysis to detect IGHV mutation status at any time point since diagnosis.
    8. Each subject (or legally authorized representative if allowed per local regulations) must be willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information.
    1 Uomini e donne >=18 anni di età (o età legale per il consenso nella giurisdizione nella quale lo studio si svolgerà);
    2 Diagnosi di LLC che soddisfa i criteri diagnostici pubblicati
    a Cellule B monoclonali (con restrizione per catena leggera kappa o lambda) che co-esprimono a livello clonale >=1 marcatore di cellule B (CD19, CD20 e CD23) e CD5
    b I prolinfociti possono comprendere <55% di linfociti del sangue
    c Presenza di >=5 x 10^9 linfociti B/l (5000/µL) nel sangue periferico (in qualsiasi momento a partire dalla diagnosi iniziale)
    3 Malattia attiva,in basead almeno uno dei criteri IWCLL del 2018:
    a Evidenza di insufficienza midollare progressiva,manifestata dallo sviluppo o peggioramento dell’anemia (emoglobina <10 g/dl) e/o trombocitopenia (piastrine <100.000/µL)
    b Splenomegalia massiva (ovvero >=6 cm sotto il margine costale sinistro),progressiva o sintomatica
    c Linfoadenopatia massiva (ovvero >=10 cm sul diametro più lungo),progressiva o sintomatica
    d Linfocitosi progressiva con un incremento di >50% nell’arco di un periodo di 2 mesi o di un tempo di raddoppiamento linfocitario (LDT) di <6 mesi.L’LDT può essere ottenuto mediante estrapolazione per regressione lineare della conta linfocitaria assoluta,ottenuta a intervalli di 2 settimane in un periodo di osservazione che va dai 2 ai 3 mesi.Nei partecipanti con conte linfocitarie iniziali nel sangue di <30x109/l (30.000/µl),l’LDT non va utilizzato come parametro singolo per definire l’indicazione di trattamento.Inoltre,fattori che contribuiscono alla linfocitosi o alla linfoadenopatia diversi da LLC (per es. infezioni) sono da escludere
    e Anemia autoimmune e/o trombocitopenia scarsamente responsiva alla terapia standard
    f Sintomi B documentati nella scheda del partecipante con misure obiettive di supporto,a seconda dei casi,definiti come >=1 dei seguenti sintomi o segni correlati alla malattia (fare riferimento al protocollo per i sintomi correlati)
    4 Soddisfacimento di 1 dei seguenti criteri:
    a Non essere stati sottoposti a precedenti terapie per il trattamento della LLC e soddisfacimento di 1 dei seguenti criteri:
    i Punteggio di >6 sulla scala di valutazione cumulativa della malattia (CIRS)
    ii Clearance della creatinina da 30 a 69 ml/min, calcolata mediante equazione di Cockcroft-Gault
    b Essere stati sottoposti in precedenza a terapia per la LLC e risultare refrattari o recidivanti alla LLC
    c Essere stati sottoposti a precedente terapia con inibitori della tirosin-chinasi di Bruton (BTKi) (ovvero partecipanti che hanno interrotto un BTKi per qualsiasi motivo, ad eccezione della progressione della malattia) per la LLC
    5 Stato della prestazione del Gruppo cooperativo orientale di oncologia (ECOG) <=2
    6 I soggetti di sesso femminile potenzialmente fertili (ovvero non chirurgicamente sterili o in post-menopausa),sessualmente attivi con un partner di sesso maschile non sterilizzato,devono utilizzare =1 metodo contraccettivo altamente efficace a partire dal momento dello screening e accettare di proseguire l’utilizzo di tali precauzioni per 2 giorni dopo l’ultima dose del trattamento dello studio.Non sono richieste misure contraccettive e restrizioni sulla donazione di sperma nei soggetti maschili.
    7 Risultati dell’ibridazione fluorescente in situ (FISH) nei 60 giorni precedenti o durante lo screening che rispecchino la presenza o assenza di del(17p),13q del,11q del e della trisomia del cromosoma 12 insieme alla percentuale di cellule con delezione,insieme a sequenziamento TP53.I partecipanti devono anche presentare l’analisi molecolare,per il rilevamento dello stato mutazionale del gene della regione variabile della catena pesante dell’immunoglobulina (IGHV) in qualsiasi punto temporale dopo la diagnosi

    Per tutti gli altri criteri di inclusione,si prega di fare riferimento al protocollo
    E.4Principal exclusion criteria
    1. Participants who have had disease progression while on a BTKi for any malignant or nonmalignant condition.
    2. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, early stage prostate cancer, or other cancer from which the participant has been disease-free for =2 years.
    3. History of confirmed progressive multifocal leukoencephalopathy.
    4. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months before screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval using Fridericia's formula (QTcF) >480 msec at screening. Note: participants with rate-controlled, asymptomatic atrial fibrillation are allowed to enroll in the study.
    5. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
    6. Evidence of active Richter's transformation. If Richter's transformation is suspected (i.e., lactate dehydrogenase [LDH]
    increased, asymmetric fast lymph node growth or clinical suspicion), it should be ruled out with positron emission tomographycomputed tomography (PET-CT) and/or biopsy according to guidelines.
    7. Central nervous system (CNS) involvement by CLL.
    8. Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with participants who are on ongoing anti-infective treatment and participants who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment.
    a. Participants who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus PCR result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded.
    b. Participants who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded.
    9. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (>20 mg daily of prednisone or equivalent for longer than 2 weeks).
    10. History of stroke or intracranial hemorrhage within 6 months before the first dose of study treatment.
    11. History of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
    12. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before Screening.
    13. Major surgical procedure within 4 weeks before first dose of study treatment. Note: Participants who have had major surgery, must have recovered adequately from any toxicity and/or complications from the intervention before the first dose
    of study treatment.

    For all other exclusion criteria, please refer to protocol.
    1. Partecipanti che hanno manifestato progressione della malattia durante la terapia con un BTKi per un qualsiasi tumore maligno o non maligno.
    2. Precedente tumore maligno (diverso da LLC), fatta eccezione per carcinoma basocellulare o carcinoma cutaneo a cellule squamose, carcinoma in situ, cancro alla prostata allo stadio precoce adeguatamente trattato o altro tumore per cui il partecipante è stato libero da malattia per =2 anni.
    3. Anamnesi di leucoencefalopatia multifocale progressiva confermata.
    4. Malattia cardiovascolare significativa, come le aritmie sintomatiche, l’insufficienza cardiaca congestizia o l’infarto del miocardio nei 6 mesi precedenti allo screening oppure qualsiasi cardiopatia di classe 3 o 4, secondo la definizione della classificazione funzionale della New York Heart Association, o intervallo QT corretto mediante formula di Fridericia (QTcF) >480 msec allo screening. Nota: ai partecipanti con fibrillazione atriale asintomatica, con frequenza controllata è consentito l’arruolamento nello studio.
    5. Sindrome da malassorbimento, malattia che influisce significativamente sulla funzione gastrointestinale, resezione dello stomaco, resezione estensiva dell’intestino tenue, che potrebbe incidere sull’assorbimento, malattia infiammatoria intestinale sintomatica, ostruzione intestinale parziale o completa o restrizioni gastriche e chirurgia bariatrica, come ad esempio bypass gastrico.
    6. Evidenza di trasformazione di Richter attiva. Se si sospetta la trasformazione di Richter (ovvero un aumento di lattato deidrogenasi [LDH] rapida crescita linfonodale asimmetrica o sospetto clinico), è da escludere con tomografia ad emissione di positroni- tomografia computerizzata (PET-TAC) e/o biopsia secondo le linee guida.
    7. Coinvolgimento del sistema nervoso centrale (SNC) da parte della LLC.
    8. Anamnesi nota di infezione da virus dell’immunodeficienza umana, stato sierologico che rispecchia un’infezione attiva da virus dell’epatite B o una da virus dell’epatite C, infezione sistemica attiva non controllata, insieme a partecipanti in trattamento antinfettivo in corso e partecipanti vaccinati con vaccino vivo attenuato nelle 4 settimane precedenti alla prima dose di trattamento dello studio.
    a. Partecipanti positivi agli anticorpi anti-antigene core dell'epatite B (anti-HBc) e negativi agli anticorpi anti-antigene di superficie dell’epatite B (anti-HBs) dovranno presentare un risultato negativo al test di reazione a catena della polimerasi (PCR) del virus dell’epatite B prima dell’arruolamento. Coloro che sono positivi all’antigene di superficie dell’epatite B (HBsAg) o positivi al test PCR del virus dell’epatite B saranno esclusi.
    b. I partecipanti positivi agli anticorpi del virus dell’epatite C dovranno presentare un risultato negativo al test PCR del virus dell’epatite C prima dell’arruolamento. Coloro che sono positivi al test PCR del virus dell’epatite C saranno esclusi.
    9. Anemia emolitica autoimmune non controllata oppure porpora trombocitopenica idiopatica, definita come calo dell’emoglobina o della conta delle piastrine secondaria a una distruzione autoimmune entro il periodo di screening o necessità di elevate dosi di steroidi (>20 mg/die di prednisone o equivalente per più di 2 settimane).
    10. Anamnesi di ictus o emorragia intracranica nei 6 mesi precedenti alla prima dose di trattamento dello studio.
    11. Anamnesi di diatesi emorragica (per es. emofilia o malattia di von Willebrand).
    12. Presenza di ulcera gastrointestinale diagnosticata mediante endoscopia nei 3 mesi precedenti allo screening.
    13. Intervento chirurgico maggiore nelle 4 settimane precedenti alla prima dose di trattamento dello studio. Nota: I partecipanti che hanno subito un intervento chirurgico maggiore devono essersi ripresi adeguatamente da eventuali tossicità e/o complicanze dell’intervento prima della prima dose del trattamento dello studio.

    Per tutti gli altri criteri di esclusione, si prega di fare riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and relatedness of all AEs, which will also include:
    - Grade >=3 AEs
    - SAEs
    - AESI defined as ventricular arrhythmias
    - AEs that lead to discontinuation of treatment
    - ECIs defined as cardiac rhythm disorders, opportunistic infections,interstitial lung disease, major hemorrhage, cytopenias and second primary malignancies
    Frequenza e correlazione di tutti gli eventi avversi, che includerà anche:
    • Eventi avversi di grado >=3
    • Eventi avversi gravi
    • Evento avverso di speciale interesse definito come aritmia ventricolare
    • Eventi avversi che portano all’interruzione del trattamento
    • Eventi di interesse clinico definiti come disturbi del ritmo cardiaco, infezioni opportunistiche, malattia polmonare interstiziale, emorragia maggiore, citopenie e seconde neoplasie primarie
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analyses at the study end
    Analisi finale alla chiusura dello studio
    E.5.2Secondary end point(s)
    - ORR (objective response rate)
    - DOR (duration of response)
    - PFS (progression-free survival)
    - Tasso di risposta obiettiva
    - Durata della risposta
    - Sopravvivenza libera da progressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ORR will be defined as a subject achieving CR, CRi, or PR, according to the IWCLL 2018 criteria as assessed by the investigator.
    - Duration of response (DOR) will be defined as the time from the first objective response of CR, CRi, or PR to the time of documented disease progression or death due to any cause, whichever occurs first.
    - PFS will be defined as the interval from the start of study treatment with study treatment to completion of 48 cycles or the earlier of the first documentation of disease progression or death from any cause.
    - il tasso di risposta obiettiva sarà definito come soggetto che raggiunge la risposta completa (CR), la risposta completa con ripresa incompleta del midollo (CRi), o risposta parziale (PR), secondo i criteri IWCLL 2018, secondo giudizio dello sperimentatore.
    - la durata della risposta sarà definita come tempo dalla prima risposta obiettiva di CR, iCR o PR al tempo di progressione documentata della malattia o decesso per qualsiasi causa, qualunque avvenga prima.
    - sopravvivenza libera da progressione sarà definita come intervallo dall'inizio del trattamento con il farmaco in studio al completamento dei 48 cicli o quello che avviene prima tra la prima progressione documentata della malattia o il decesso per qualsiasi causa.
    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 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. 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 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 Yes
    E. description
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Korea, Republic of
    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
    The duration of the study will be approximately 72 months from the first subject enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study treatment (28 days per cycle); additional study time will be accrued during the followup period for those subjects remaining on study treatment after completion of 48 cycles (the amount of time will vary by subject).
    La durata dello studio sarà di circa 72 mesi dall'arruolamento del primo soggetto. questa durata include un periodo di circa 24 mesi per il reclutamento e un trattamento previsto di 48 cicli (28 giorni per ciclo); sarà accumulato un tempo aggiuntivo allo studio durante il periodo di follow-up per quei soggetti che rimangono in trattamento dopo completamento dei 48 cicli (la quantità di tempo varierà in base al soggetto).
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 Yes
    F. of subjects incapable of giving consent
    Subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition (e.g. coma, mental disability and in accordance with national requirements)
    I soggetti incapaci di dare il proprio consenso per motivi fisici o psicologici, o per motivazioni legate alle proprie condizioni mediche (ad es. coma, disabilità mentale e secondo i requisiti nazionali)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 297
    F.4.2.2In the whole clinical trial 600
    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)
    All subjects will have a Safety Follow-Up (SFU) visit approximately 30 days after the last dose of study treatment. If a subject continues to derive benefit from treatment at the end of 48 cycles, they will
    continue to be provided with study treatment (for more details please refer to protocol section 4.3)
    Tutti i soggetti avranno una visita di Safety Follow-Up (SFU) circa 30 giorni dopo l'ultima dose di trattamento in studio. Se un soggetto continua a trarre beneficio dal trattamento alla fine dei 48 cicli, continueranno a ricevere il trattamento in studio (per tutti i dettagli, si prega di fare riferimento alla sezione 4.3 del protocollo).
    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 Decision2020-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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