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    Summary
    EudraCT Number:2017-004251-23
    Sponsor's Protocol Code Number:LAL2317
    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:2021-06-14
    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 number2017-004251-23
    A.3Full title of the trial
    National Treatment Program with Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-Negative B-Cell
    Programma terapeutico nazionale con chemioterapia e Blinatumomab in sequenza per il miglioramento della risposta in termini di malattia minima residua e della sopravvivenza nei pazienti adulti affetti da Leucemia Acuta Linfoblastica da precursori delle cellule B Philadelphia negativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sequential treatment with chemotherapy and Blinatumomab to improve the response and survival of patients affected by a form of cancer that affects the cells from which give origin to white cells (cells present in blood)
    Trattamento in sequenza con chemioterapia e Blinatumomab per migliorare la risposta e la sopravvivenza di pazienti affetti da una forma di tumore che colpisce le cellule dalle quali hanno origine i globuli bianchi (cellule presenti nel sangue)
    A.3.2Name or abbreviated title of the trial where available
    LAL 2317
    LAL 2317
    A.4.1Sponsor's protocol code numberLAL2317
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03367299
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 supportAmgen S.r.l.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportA.I.L Associazione Italiana contro le Leucemie
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione G.I.M.EM.A Franco Mandelli ONLUS
    B.5.2Functional name of contact pointCentro Dati
    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 BLINCYTO - 38,5 MICROGRAMMI - POLVERE PER CONCENTRATO E SOLUZIONE PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - POLVERE:FLACONCINO (VETRO) 38,5MCG - SOLUZIONE: 10 ML FLACONCINO (VETRO) - 1 FLACONCINO + 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.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/3/09/650
    D.3 Description of the IMP
    D.3.1Product nameBlinatumomab
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBlinatumomab
    D.3.9.1CAS number 853426-35-4
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Acute Lymphoblastic Leukemia Philadelphia Chromosome Negative (Ph-)
    Leucemia Linfoblastica Acuta Philadelphia Negativa (Ph-)
    E.1.1.1Medical condition in easily understood language
    Acute Lymphoblastic Leukemia Philadelphia Chromosome Negative (Ph-)
    Malattia causata dalla crescita abnorme di alcune cellule del midollo osseo (tessuto molle presente all'interno di alcune ossa) progenitrici dei linfociti, cellule che si trovano nel sangue
    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 LLT
    E.1.2Classification code 10000844
    E.1.2Term Acute lymphoblastic leukaemia
    E.1.2System Organ Class 100000004864
    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 of the trial is to assess the impact of blinatumomab in increasing the rate of early MRD negativiy at week 14 i.e. TP3 in adult patients with Ph- CD19+ BCP ALL in first CR.
    L¿obiettivo primario dello studio ¿ valutare l¿impatto del blinatumomab nell¿aumentare il tasso di negativit¿ precoce della MRD alla fine della settimana 14, per esempio al tempo 3 nei pazienti adulti con Ph- CD19+ BCP ALL in prima CR.
    E.2.2Secondary objectives of the trial
    1. Complete remission (CR)
    2. Disease-free survival (DFS)
    3. Overall survival (OS)
    4. Cumulative incidence of relapse (CIR)
    5. Bone marrow MRD response at weeks 4, 10, 23 and 30, i.e. TPs 1, 2, 4 and 5
    6. Treatment-related mortality (TRM)
    7. MRD negativity, DFS, OS, CIR and TRM according to patient age, diagnostic ALL subset and risk category
    8. MRD monitoring
    9. Safety
    1. Complete remission (CR)
    2. Disease-free survival (DFS)
    3. Overall survival (OS)
    4. Cumulative incidence of Relapse (CIR)
    5. Risposta MRD midollare alle settimane 4, 10, 23 e 30, per esempio ai tempi 1, 2, 4 e 5
    6. Treatment-related mortality (TRM)
    7. Negativit¿ della MRD, DFS, OS, CIR e TRM secondo et¿, sottotipo di ALL e categoria di rischio
    8. Monitoraggio della MRD
    9. Sicurezza
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 1.0
    Date: 06/11/2017
    Title: Translational research
    Objectives: To evaluate the role of effector cells (CD3+, T-regs)

    Farmacogenetica
    Versione: 1.0
    Data: 06/11/2017
    Titolo: Ricerca traslazionale
    Obiettivi: Valutare il ruolo delle cellule effettrici (CD3+, T-reg)
    E.3Principal inclusion criteria
    1. Signed written informed consent according to ICH/EU/GCP and national local laws.
    2. Age 18-65 years.
    3. A diagnosis of untreated Ph- CD19+ BCP ALL is required, either de novo or secondary to chemo-radiotherapy for another cancer. Pre-treatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. All diagnostic procedures need to be performed on freshly obtained bone marrow and blood samples.
    4. Full cytological, cytochemical, cytogenetic and immunobiological disease characterization according to EGIL and WHO classifications.
    5. BM and PB sampling are required for MRD evaluations. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the forwarding of samples for MRD studies are given in Appendix A.
    6. ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, that is considered and/or documented to be reversible following the application of anti-leukemic therapy and appropriate supportive measures.
    1. Firma del consenso informato secondo le ICH/EU/GCP e la normativa locale nazionale.
    2. 18-65 anni di età.
    3. Diagnosi di Ph- CD19+ BCP ALL non trattata, o de novo o secondaria a una chemio-radioterapia per un’altra neoplasia. È consentito il pre-trattamento con basse dosi di corticosteroidi nei pazienti che presentino iperleucocitosi. Prima dell’arruolamento e nella pre-fase questo è permesso solo nei pazienti che presentino sintomi clinici correlati alla malattia gravi e potenzialmente mortale. Tutte le procedure diagnostiche devono essere eseguite su campioni freschi di midollo osseo (BM, bone marrow) e sangue periferico (PB, peripheral blood).
    4. Completa caratterizzazione citologica, citochimica, immunofenotipica, citogenetica e molecolare della malattia secondo la classificazione EGIL e WHO.
    5. Raccolta di campioni di BM e PB per lo studio sulla valutazione della MRD. Indicazioni dettagliate riguardo la registrazione del paziente, la conservazione del materiale diagnostico rappresentativo e il work up diagnostico, compresa la spedizione dei campioni per il work up diagnostico e per gli studi di follow up sulla MRD, sono contenute nell’Appendice A.
    6. ECOG performance status 0-2, salvo il caso in cui il performance status di 3 sia inequivocabilmente causato dalla malattia stessa, (e non da comorbidità pre-esistenti,) e la reversibilità sia valutata e/o documentata in seguito all’impiego di una terapia anti-leucemica e di misure di supporto appropriate.
    E.4Principal exclusion criteria
    1. Diagnosis of Burkitt’s leukemia or lymphoma (mature B-ALL), Ph+ ALL, CD19- BCP ALL, T-ALL, lymphoblastic lymphoma (BM involvement by blast cells <25%).
    2. Active CNS leukemia documented by diagnostic lumbar puncture on days -1 to -5 prior to the
    first blinatumomab administration, or any other clinical sign or symptom ascribable to symptomatic/documented CNS disease at time of each planned blinatumomab course.
    3. Down’s syndrome.
    4. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient’s ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
    5. Presence of serious, active, uncontrolled infections.
    6. Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is sent off study.
    7. A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy <1 year.
    8. Pregnancy declared by the patient herself, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with ALL therapy. A pregnancy test is performed at diagnosis but does not preclude the enrolment into study. Fertile patients will be advised to adopt contraceptive methods while on treatment
    1. Diagnosi di leucemia/linfoma di Burkitt, CD19- BCP ALL, Ph+ ALL, T-ALL, linfoma linfoblastico (con midollo osseo popolato da blasti <25%).
    2. Leucemia attiva nel Sistema Nervoso Centale diagnosticata tramite puntura lombare effettuata tra il primo ed il quinto giorno precedente la prima somministrazione di blinatumomab, o qualsiasi altro sintomo o segno clinico ascrivibile ad una sintomatica/documentata patologia del Sistema Nervoso Centale al momento di ogni ciclo programmato di blinatumomab.
    3. Sindrome di Down.
    4. Patologia pre esistente non controllata come insufficenza cardiaca (congestizia/ischemica, infarto acuto del miocardio nei tre mesi precedenti, NYHA classes III and IV), patologia epatica grave con bilirubina sierica >3 mg/dL e/o ALT >3 volte rispetto al valore normale (a meno che non sia attribuibile alla ALL), deficit della funzionalità renale con creatinina sierica >2 mg/dL (a meno che non sia attribuibile a ALL), e disturbi neuropsichiatrici severi che inficino la capacità del paziente di comprendere e firmare il consenso informato, o di far fronte al piano di trattamento previsto. N.B. In caso di analisi epatiche e renali alterate, i criteri di eleggibilità possono essere rivalutati a 24-96 ore, successivamente all’istituzione di misure di supporto adeguate.
    5. Presenza di infezioni, gravi, attive e incontrollate.
    6. Pre-esistente condizione sierologica di positività ad HIV (es. già nota prima dell’arruolamento). Se la positività all’HIV viene individutata successivamente all’arruolamento, il paziente viene messo fuori dallo studio.
    7. Storia di neoplasia che non sia in fase di remissione, successivamente a chirurgia e/o radioterapia e/o chemioterpia, con una aspettativa di vita inferiore ad un anno.
    8. Gravidanza dichiarata dal paziente, a meno che non venga presa la decisione di indurre un aborto terapeutico in accordo con il paziente, al fine di continuare la terapia per la ALL. Un test di gravidanza viene effettuato alla diagnosi, ma non preclude l’arruolamento allo studio. Alle pazienti fertili è consigliata l’adozione di metodi contraccettivi durante il trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    L'endpoint primario di questo studio è di aumentare il tasso di negatività della MRD precoce ottenuto dopo il primo ciclo di blinatumomab (MRD TP3 / settimana 14) in pazienti adulti con ALL-BCP Ph-CD19 +.
    The primary endpoint of this study is to increase the early MRD negativity rate obtained after blinatumomab course 1(MRD TP3/week 14) in adult patients with Ph- CD19+ BCP ALL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14
    Settimana 14
    E.5.2Secondary end point(s)
    1. Complete remission (CR) after induction chemotherapy course 1 or 2.
    2. Disease-free survival (DFS) at 36 months
    3. Overall survival (OS) at 36 months
    4. Cumulative incidence of relapse (CIR) at 36 months
    5. Percentage of patients with bone marrow MRD negative, weakly positive =10-4, and positive
    =10-4 or 10-3 at weeks 4-30, i.e. TPs 1-5
    6. Treatment-related mortality (TRM)
    7. DFS, OS, CIR and TRM in different age groups, diagnostic ALL subsets and risk categories
    8. MRD levels at different time points
    9. Safety in terms of number and rate of adverse events and serious adverse events.
    1. Remissione completa (CR) dopo il primo e secondo ciclo di chemioterapia
    2. Sopravvivenza libera da malattia (DFS) a 36 mesi
    3. Sopravvivenza globale (OS) a 36 mesi
    4. Incidenza cumulativa di recidiva (CIR) a 36 mesi
    5. Percentuale di pazienti con midollo osseo MRD negativo, debolmente positivo =10-4 e positivo
    =10-4 o 10-3 alle settimane 4-30, ovvero TP 1-5
    6. Mortalit¿ correlata al trattamento (TRM)
    7. DFS, OS, CIR e TRM in diverse fasce d'et¿, ALL sottoinsiemi diagnostici e categorie di rischio
    8. Livelli MRD in diversi momenti
    9. Sicurezza in termini di numero e frequenza di eventi avversi e eventi avversi gravi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 1st and 2nd cycle of chemotherapy (CR)
    At 36 months (OS, DFS, CIR)
    MRD every 3 months
    At the end of the study
    Dopo il primo e secondo ciclo di chemioterapia (CR)
    A 36 mesi (OS, DFS, CIR)
    MRD ogni 3 mesi
    Alla fine dello studio
    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 Yes
    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 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 concerned56
    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
    LVLS
    LVLS
    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 months8
    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 months8
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state149
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 149
    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)
    Normal clinical practice
    Secondo normale 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 G.I.M.EM.A
    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 Decision2018-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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