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    Summary
    EudraCT Number:2019-000159-14
    Sponsor's Protocol Code Number:CLL1818
    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:2020-12-16
    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 number2019-000159-14
    A.3Full title of the trial
    Prospective study on the incidence of hepatitis B virus reactivation in untreated patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive treated with Rituximab, Chemotherapy and Tenofovir Alafenamide.
    Studio Prospettico sull’incidenza della riattivazione del virus dell’Epatite B nei pazienti HBsAg positivi e non trattati con Linfoma diffuso a grandi cellule B / Leucemia Linfoide Cronica trattati con Rituximab, Chemioterapia e Tenofovir Alafenamide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to evaluate the frequency of reactivation of hepatitis B virus, a serious infection that affects the liver caused by a virus, in patients suffering from two forms of blood cancer, diffuse large B-cell lymphoma and chronic lymphoid leukemia, since most of the chemotherapeutic drugs used lower the host's immune defenses thus increasing the risk of an exacerbation of the infection in HBV carriers.
    Lo scopo dello studio è valutare la frequenza di riattivazione del virus dell'epatite B,grave infezione che colpisce il fegato causata da un virus, in pazienti affetti da due forme di tumore del sangue, Linfoma diffuso a grandi cellule B e Leucemia Linfoide Cronica, poiché la maggior parte dei farmaci chemioterapici utilizzati abbassano le difese immunitarie dell’ospite aumentando quindi il rischio di una riacutizzazione dell’infezione nei portatori di HBV.
    A.3.2Name or abbreviated title of the trial where available
    CLL1818
    CLL1818
    A.4.1Sponsor's protocol code numberCLL1818
    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 SponsorFONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
    B.1.3.4CountryItaly
    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 supportGilead Sciences S.r.l.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAIL Associazione Italiana contro le Leucemie-Linfomi e Mieloma ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli ONLUS
    B.5.2Functional name of contact pointCentro Dati GIMEMA
    B.5.3 Address:
    B.5.3.1Street AddressVia Casilina, 5
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00182
    B.5.3.4CountryItaly
    B.5.4Telephone number0670390526
    B.5.5Fax number0670390540
    B.5.6E-mailgimema@gimema.it
    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 Vemlidy 25 mg compresse rivestite con film.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTenofovir Alafenamide (TAF)
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTenofovir Alafenamide
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTenofovir Alafenamide Fumarato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 is a neoplasm of the lymphatic system characterized by an accumulation of B lymphocytes in peripheral blood, bone marrow and lymphatic organs.
    Diffuse Large Cell B Lymphoma is the most common subtype of non-Hodgkin's lymphoma, an aggressive tumor with rapid growth.
    Hepatitis B is an infectious disease, caused by the HBV virus, which causes acute or chronic inflammation of the liver, with consequent damage or destruction of hepatocytes.
    La Leucemia Linfatica Cronica è una neoplasia del sistema linfatico caratterizzata da un accumulo di linfociti B nel sangue periferico, nel midollo osseo e negli organi linfatici.
    Il Linfoma Diffuso a Grandi Cellule B è il sottotipo più comune di linfoma non Hodgkin, neoplasia aggressiva con crescita rapida.
    L'Epatite B è una malattia infettiva, causata dal virus HBV, che provoca un'infiammazione del fegato, acuta o cronica, con conseguente danneggiamento o distruzione degli epatociti.
    E.1.1.1Medical condition in easily understood language
    CLL and DLBCL are types of tumors that cause uncontrolled growth of some blood cells in some lymphatic organs.
    Hepatitis B is a serious viral infection that affects the liver.
    CLL e DLBCL sono tipi di tumore che provocano crescita incontrollata di alcune cellule del sangue a livello di alcuni organi linfatici.
    L’epatite B è una grave infezione virale che colpisce il fegato.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10058827
    E.1.2Term Hepatitis B reactivation
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019731
    E.1.2Term Hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10008958
    E.1.2Term Chronic lymphocytic leukaemia
    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 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the incidence of HBV reactivation within the first 6 months treatment period in HBsAg positive patients with DLBCL /Chronic Lymphoid Leukemia treated with Rituximab, chemotherapy and TAF.
    L’obiettivo primario è quello di valutare l’incidenza della riattivazione dell’HBV entro i primi 6 mesi di trattamento nei pazienti HBsAg positivi con DLBCL / Leucemia Linfoide Cronica trattati con Rituximab, Chemioterapia e TAF.
    E.2.2Secondary objectives of the trial
    1. To estimate the incidence of HBV reactivation during the 12-month treatment of TAF as a single agent
    2. To estimate the incidence of HBV reactivation during the 12 months after TAF treatment
    3. To estimate the incidence of HBV-related hepatitis or liver failure
    4. To estimate the incidence of immune-chemotherapy delay due to HBV-reactivation
    5. To estimate the overall survival
    6. To estimate the progression free-survival
    7. To evaluate the safety profile
    1. Stimare l’incidenza della riattivazione dell’HBV durante i 12 mesi di trattamento con TAF come monoterapia.
    2. Stimare l’incidenza della riattivazione dell’HBV durante i 12 mesi successivi al trattamento con TAF.
    3. Stimare l’incidenza di epatiti o insufficienze epatiche correlate all’HBV.
    4. Stimare l’incidenza del ritardo della somministrazione dell’immunochemioterapia dovuto alla riattivazione dell’HBV.
    5. Stimare la sopravvivenza globale.
    6. Stimare la sopravvivenza libera da progressione.
    7. Stimare il profilo di sicurezza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent according to ICH/EU/GCP and national local laws.
    2) Male/non-pregnant/non-lactating female subjects >18 years old with newly diagnosed DLBCL/Chronic Lymphoid Leukemia who are going to receive treatment with rituximab in combination with chemotherapy. Female patients of childbearing potential and non-sterile male patients must practice two reliable methods of birth control with partner(s) beginning with initial treatment administration and continuing to 12 months after the last dose of study drug. Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of study drug.
    3) HBsAg positivity, serum HBV-DNA negative or positive (<2000/IU), and normal liver function, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin. (inactive carriers)
    4) No previous treatment with antiviral drugs for HBV infection
    5) Patients renal function satisfying one of the following conditions: - Glomerular filtration (GF) = 50 ml/min using the abbreviated MDRD:
    186 × Creatinine (Cr) -1.154 × age -0.203 [Note: a multiplication factor of 0.742 for females and of 1.21 for patients of black race must be applied]
    - Creatinine clearance (CrCl) = 50 ml/min according to the Cockcroft-Gault equation:
    (140-age in years) * (body weight [in kg]) / (72) * (serum creatinine [in mg/dl]) [Note: a multiplication factor of 0.85 must be applied for females]
    1. Consenso informato scritto firmato in accordo con ICH/EU/GCP e le leggi nazionali locali.
    2. Soggetti Maschi/ Femmine non in stato di gravidanza, non in allattamento con età superiore ai 18 anni con nuova diagnosi DLBCL / Leucemia Linfoide Cronica che riceveranno il trattamento con Rituximab in combinazione con chemioterapia. Pazienti donne in età fertile e uomini non sterili dovranno adottare due tipologie di metodi contraccettivi affidabili o praticare la completa astensione dai rapporti sessuali per l’intera durata dello studio e per almeno i dodici mesi successivi all’ultima dose di farmaco. I pazienti uomini, inoltre, dovranno accettare di astenersi dalla donazione di sperma durante e dopo lo studio per i 12 mesi successivi l’ultima dose di farmaco
    3. Positività HBsAg, negatività o positività HBV-DNA sierico (<2000/IU), normale funzionalità epatica, inclusi alanina amino transferasi (ALT), aspartato amino transferasi (AST) e bilirubina (carrier inattivati).
    4. Nessun precedente trattamento con farmaci antivirali per l’infezione da HBV.
    5. Funzioni renali del paziente che soddisfino una delle seguenti condizioni:
    - Filtrazione Glomerulare (GF) = 50ml/min utilizzando MDRD:
    186 × Creatinina (Cr) – 1.154 x età – 0.203 [Nota: deve essere applicato il fattore di moltiplicazione di 0.742 per le donne e di 1.21 per i pazienti di razza nera].
    - Clearance della Creatinina (CrCl) = 50 ml/min in accordo con l’equazione Cockcroft-Gault: (140- età in anni) x (peso corporeo [in kg]) / (72) x (creatinina sierica [in mg/dl]) [Nota: per le donne deve essere applicato il fattore di moltiplicazione di 0.85]
    E.4Principal exclusion criteria
    1) Hepatic insufficiency for any reason (e.g. decompensated liver disease and with a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
    2) History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary biliary cirrhosis, Wilsons’ disease
    3) Positive viral markers, such as IgM antibody to hepatitis A virus, hepatitis C virus, IgG antibody to hepatitis D virus, IgM antibody to hepatitis E virus, or antibody to HIV
    4) Pregnant or breast-feeding women
    5) Other major systemic disease, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider to be significant risk
    6) Patients with moderate or severe renal failure satisfying one of the following conditions: - Glomerular filtration (GF) < 50 ml/min using the abbreviated MDRD: 186 × Creatinine (Cr) -1.154 × age -0.203 [Note: a multiplication factor of 0.742 for females and of 1.21 for patients of black race must be applied] - Creatinine clearance (CrCl) <50 ml/min according to the Cockcroft-Gault equation: (140-age in years) * (body weight [in kg])
    7) Intolerance to any of the components of the therapeutic regimen. Treatment with any investigational medicinal product (unapproved) in the last 30 days.
    8) Any other disorder that, in the investigator's opinion, makes the patient ineligible for recruitment or that could interfere in his/her participation or in the conclusion of the study.
    9) Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
    10) Co-Administration of drugs interacting with TAF (please refer to Appendix C).
    1. Insufficienza epatica di ogni tipo [ad esempio, malattia epatica scompensata e punteggio di Child Pugh Turcotte (CPT)>9 (ossia di classe C)].
    2. Storia di disturbi epatici come epatiti C, D, epatiti autoimmune, cirrosi biliare primitiva, malattia di Wilsons.
    3. Marcatori virali positivi, come anticorpi IgM per il virus dell’epatite A, virus dell’epatite C, anticorpi IgG per il virus dell’epatite D, anticorpi IgM per il virus dell’epatite E, anticorpi per l’HIV.
    4. Donne in stato di gravidanza o in allattamento.
    5. Altre importanti malattie sistemiche, come infezioni in corso, disturbi cardiaci significativi, deficit neurologici o disordini psichiatrici, che lo sperimentantore consideri siano fattori di rischio.
    6. Pazienti con moderata o grave insufficienza renale che soddisfi una delle seguenti condizioni:
    - Filtrazione Glomerulare (GF) < 50 ml/min utilizzando l’unità MDRD: 186 × Creatinina (Cr) – 1.154 × età – 0.203 [Nota: deve essere applicato il fattore di moltiplicazione di 0.742 per le donne e di 1.21 per i pazienti di razza nera] – Clearance della Creatinina (CrCl) < 50 mil/min in accordo con l’equazione di Cockcroft-Gault: (140- età in anni) x (peso corporeo [in kg]).
    7. Intolleranza a qualche componente del regime terapeutico. Trattamento con un farmaco sperimentale (non approvato) negl’ultimi 30 giorni.
    8. Qualsiasi altro disturbo che, secondo l’opinione dello sperimentatore, renda il paziente non eleggibile all’arruolamento o che potrebbe interferire con la sua partecipazione o con le finalità dello studio.
    9. Pazienti affetti da rari problemi ereditari di intolleranza al galattosio, deficit di lattasi o con malassorbimento di glucosio galattosio.
    10. Co-somministrazione di medicinali che interagiscono con il TAF (fare riferimento all’appendice C).
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the percentage of patients presenting HBV reactivation within 6 months following the start of treatment with Rituximab, chemotherapy and TAF in in DLBCL and Chronic Lymphoid Leukemia patients.
    Valutazione della percentuale di pazienti che presentano riattivazione dell'HBV entro 6 mesi dall'inizio del trattamento con Rituximab, chemioterapia e TAF nei pazienti con DLBCL e leucemia linfoide cronica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the percentage of patients with a DNA level of HBV > 10 IU / ml at week 48, then within 6 months of starting treatment with Rituximab, chemotherapy and TAF.
    Valutazione della percentuale di pazienti con un livello di DNA dell' HBV > 10 UI / ml alla settimana 48, quindi entro 6 mesi dall'inizio del trattamento con Rituximab, chemioterapia e TAF .
    E.5.2Secondary end point(s)
    1. Assessment of the percentage of patients presenting HBV reactivation during the 12-month treatment of TAF as a single agent in in DLBCL and Chronic Lymphoid Leukemia patients
    2. Assessment of the percentage of patients presenting HBV reactivation during the 12 months after TAF treatment in DLBCL and Chronic Lymphoid Leukemia patients
    3. Rate of patients stratified by DLBCL and Chronic Lymphoid Leukemia with hepatitis related to the HBV infection or with liver failure during their participation in the study
    4. Assessment of chemotherapy delay due to HBV-reactivation in terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and Chronic Lymphoid Leukemia.
    5. Assessment of overall survival (OS) of the patients with DLBCL and with Chronic Lymphoid Leukemia
    6. Assessment of progression free-survival (PFS) of the patients with DLBCL and with Chronic Lymphoid Leukemia
    7. Safety assessment in order to estimate the incidence of adverse events and the percentage of patients who have to leave the study due to clinical adverse events or due to TAF-related laboratory abnormalities
    1. Valutazione della percentuale di pazienti che presentano la riattivazione dell'HBV durante il trattamento di TAF da 12 mesi come singolo agente nei pazienti con DLBCL e leucemia linfoide cronica
    2. Valutazione della percentuale di pazienti che presentano riattivazione dell'HBV durante i 12 mesi dopo il trattamento con TAF nei pazienti con DLBCL e leucemia linfoide cronica
    3. Tasso di pazienti stratificati da DLBCL e leucemia linfoide cronica con epatite correlata all'infezione da HBV o insufficienza epatica durante la loro partecipazione allo studio
    4. Valutazione del ritardo della chemioterapia dovuto alla riattivazione dell'HBV in termini di percentuale di pazienti con un ritardo di almeno 7 giorni tra cicli di chemioterapia stratificati mediante DLBCL e leucemia linfoide cronica.
    5. Valutazione della sopravvivenza globale (OS) dei pazienti con DLBCL e con leucemia linfoide cronica
    6. Valutazione della progressione libera sopravvivenza (PFS) dei pazienti con DLBCL e con leucemia linfoide cronica
    7. Valutazione della sicurezza al fine di stimare l'incidenza di eventi avversi e la percentuale di pazienti che devono lasciare lo studio a causa di eventi avversi clinici oa causa di anomalie di laboratorio correlate al TAF
    E.5.2.1Timepoint(s) of evaluation of this end point
    During and after chemotherapy and during the 12 months of TAF monotherapy.
    Durante e dopo la chemioterapia e durante i 12 mesi di monoterapia con TAF.
    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 No
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Prospettico, multicentrico, interventistico, a singolo braccio
    Prospective, multicenter, interventional, single-arm
    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 concerned39
    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 Information not present in EudraCT
    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
    Last Visit last subject.
    Ultima visita dell'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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 continue to be followed according to normal care provided by good clinical practice.
    I pazienti continueranno ad essere seguiti secondo la normale attività assistenziale prevista dalla buona pratica clinica.
    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 Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli 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 Decision2019-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
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