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    Summary
    EudraCT Number:2018-003517-17
    Sponsor's Protocol Code Number:ALL2518
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-20
    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 number2018-003517-17
    A.3Full title of the trial
    Asparaginase Activity Monitoring (AAM) in adult patients with Acute Lymphoblastic Leukemia (ALL).
    Monitoraggio dell’Attività dell’Asparaginasi (AAM) in pazienti adulti con Leucemia Linfoblastica Acuta (LAL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of the study is to monitor the activity of Asparaginase, an enzyme that acts by degrading asparagine, an important component of proteins without which cells can not survive.
    Normal cells can produce asparagine independently, while some cancer cells are unable to do so. Asparaginase reduces the level of asparagine in the blood cells and stops the growth of cancer cells.
    Lo scopo dello studio è monitorare l’attività dell’ Asparaginasi, un enzima che agisce degradando l’asparagina, un importante componente delle proteine senza il quale le cellule non possono sopravvivere.
    Le cellule normali possono produrre l’asparagina autonomamente, mentre alcune cellule tumorali non sono in grado di farlo. L’Asparaginasi riduce il livello di asparagina nelle cellule del sangue e arresta la crescita delle cellule tumorali.
    A.3.2Name or abbreviated title of the trial where available
    ALL2518
    ALL2518
    A.4.1Sponsor's protocol code numberALL2518
    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 supportJazz Healthcare Italy Srl
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAIL - Associazione Italiana contro le leucemie-linfoma 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 ONCASPAR - 750 U/ML - SOLUZIONE INIETTABILE/PER INFUSIONE - USO INTRAMUSCOLARE, USO ENDOVENOSO - FLACONCINO (VETRO) 5 ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    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 namePegasparaginasi
    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 INN00318900
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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.IMP: 2
    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 ERWINASE, 10.000 Unità / flaconcino, Liofilizzato per soluzione iniettabile
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameErwinia L-asparaginasi
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INN00330800
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Adult patients, aged between 18 and 65, diagnosed with Acute Ph Lymphoblastic Leukemia negative (LAL Ph-) untreated, with a favorable impact on the prognosis.
    Pazienti adulti, di età compresa tra 18 e 65 anni, con diagnosi di Leucemia Linfoblastica Acuta Ph negativa ( LAL Ph-) non trattata, con un impatto favorevole sulla prognosi.
    E.1.1.1Medical condition in easily understood language
    Blood cancer disease that begins when lymphocytes meet at the bone marrow level with neoplastic transformation, resulting in uncontrolled multiplication and progressive accumulation.
    Malattia tumorale del sangue che inizia quando i linfociti vanno incontro a livello del midollo osseo a trasformazione neoplastica, con moltiplicazione incontrollata e progressivo accumulo.
    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 10060390
    E.1.2Term Leukaemia lymphoblastic acute
    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 measure serum ASP activities during the first two cycles of therapy, in terms of intensity and duration, as surrogate parameter for asparagine (ASN) depletion.
    Obiettivo primario dello studio è misurare le attività dell’ASP sierica durante i primi due cicli di terapia, in termini di intensità e durata, quale parametro surrogato per la deplezione dell’asparagina (ASN).
    E.2.2Secondary objectives of the trial
    1) To measure serum ASP activities during the cycles 5 and 6, in terms of intensity and duration, as surrogate parameter for ASN depletion
    2)To detect any silent inactivation of the enzyme caused by an immune response.
    3) To check the failure of the ASN depletion in the samples where it is determined the silent inactivation.
    4) Safety.
    1) Misurare le attività dell’ASP sierica durante i cicli 5 e 6 , in termini di intensità e durata, quale parametro surrogato per la deplezione dell’asparagina (ASN)
    2)Rilevare qualsiasi forma di inattivazione silente dell’enzima provocata da una risposta immunitaria;
    3) Verificare l’insufficiente deplezione dell’ASN nei campioni in cui si è verificata l’inattivazione silente;
    4) 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) Age =18 – 65 years
    3) Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation
    4) ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures.
    5) For females of childbearing potential and postmenopausal females, a negative pregnancy test must be documented at Screening.
    6) Men and women should use effective contraception during treatment and for at least 6 months after Asparaginase discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with Asparaginase and should not be restarted after discontinuation of Asparaginase.
    1) Consenso informato firmato scritto nel rispetto dei principi ICH/EU/GCP e delle normative nazionali applicabili;
    2) Età compresa tra =18 - 65 anni;
    3) Diagnosi di LAL Ph- non trattata all’inizio del trattamento inclusa la PEG-ASP in induzione e consolidamento;
    4) Performance status 0-2 valutata secondo i criteri ECOG, salvo che una performance pari a 3 sia causata inequivocabilmente dalla patologia stessa e non da comorbidità preesistenti, e sia considerata e/o documentata come reversibile in seguito alla somministrazione della terapia antileucemica e delle appropriate misure di supporto.
    5) Per le donne potenzialmente fertili e donne in postmenopausa, deve essere accertato un test di gravidanza negativo allo Screening
    6) Gli uomini e le donne dovrebbero adottare un metodo contraccettivo efficace durante il trattamento e per almeno 6 mesi dopo la sospensione di Asparaginase. Come misura precauzionale, l'allattamento al seno deve essere interrotto durante il trattamento con Asparaginase e non deve essere ripreso dopo l'interruzione di Asparaginase.
    E.4Principal exclusion criteria
    1) Diagnosis of Burkitt’s leukemia
    2) Down’s syndrome
    3) Adults with Ph+ ALL
    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)
    5) Severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL)
    6) Kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL)
    7) Severe neuropsychiatric disorder that impairs the patient’s ability to understand and sign the informed consent, or to cope with the intended treatment plan
    8) Presence of serious, active, uncontrolled infections
    9) Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
    10) Pregnancy
    11) Taking any medications or herbal supplements that are known to be strong inhibitors of enzymes or medications not allowed within at least 14 days before the first dose of Peg-Asp
    1) Diagnosi di leucemia di Burkitt;
    2) Sindrome di Down;
    3) Adulti con LAL Ph+;
    4) Patologia preesistente, non controllata come insufficienza cardiaca (infarto acuto del miocardio ischemico/congestizio nei 3 mesi precedenti, aritmie non trattabili, classificazione NYHA III e IV);
    5) Insufficienza epatica grave con bilirubina sierica >3 mg/dL e/o ALT >3 superiore al limite di normalità (salvo che non sia attribuibile alla LAL);
    6) Alterazione della funzionalità renale con una creatinina sierica >2 mg/dL (salvo che non sia attribuibile alla LAL);
    7) Disturbo neuropsichiatrico grave che pregiudichi la capacità del paziente di comprendere e firmare il consenso informato o di seguire il piano di trattamento previsto;
    8) Presenza di infezioni serie, attive, non controllate;
    9) Sierologia positiva per preesistente HIV (ossia già noti prima dell’arruolamento). Nel caso la positività all’HIV sia rilevata dopo l’arruolamento, il paziente deve uscire dallo studio;
    10) Gravidanza;
    11) Assunzione di farmaci o integratori a base di erbe che sono noti per essere forti inibitori di enzimi o farmaci non consentiti entro almeno 14 giorni prima della prima dose di Peg-Asp
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to measure serum ASP activities during the first two cycles in terms of activity rate.
    L'endpoint primario di questo studio è misurare le attività dell' ASP sierica, durante i primi due cicli di terapia, in termini di tasso di attività ( intensità e durata).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Cycle 1: before drug administration (on day 10 of the cycle), after 1 week (on day 17 of the cycle), and after 2 weeks (on day 24) post PEG-ASP and on day 28 (18 days post dose).
    - Cycle 2: before drug administration (on day 8 of the cycle) and after 1 week (on day 15 of the cycle) post PEG-ASP dose.
    Dopo i primi due cicli di terapia:
    - Ciclo 1: prima della somministrazione del farmaco (il giorno 10 del ciclo), dopo una settimana (il giorno 17 del ciclo) e dopo due settimane (il giorno 24) dopo la somministrazione della PEG-ASP e il giorno 28 (18 giorni dopo la dose di farmaco).
    - Ciclo 2: prima della somministrazione del farmaco (il giorno 8 del ciclo) e dopo 1 settimana (il giorno 15 del ciclo) dopo la somministrazione della dose di PEG-ASP.
    E.5.2Secondary end point(s)
    1) To estimate the percentage of patients with any silent inactivation of the enzyme caused by an immune response.
    2) To estimate the percentage of patients with failure of the ASN depletion in the samples where it is determined the silent inactivation
    3) To provide a rational basis for making a decision whether to use an alternative preparation of ASP.
    4) Safety profile in terms of number of events and rate of patients who experiances adverse events related to ASP.
    1) Misurare le attività dell' ASP sierica, durante i cicli 5 e the 5 e 6 di terapia, in termini di tasso di attività ( intensità e durata).
    2) Valutare la percentuale di pazienti con qualsiasi inattivazione silente dell'enzima causata da una risposta immunitaria.
    3) Valutare la percentuale di pazienti con fallimento della deplezione di ASN nei campioni in cui è presente è determinata la silenziosa inattivazione
    4) Profilo di sicurezza in termini di numero di eventi e tasso di pazienti che sperimentano eventi avversi relativo a ASP
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 5 and 6 cycles:
    Cycle 5: before drug administration (on day 3 of the cycle), after 1 week (on day 10 of the cycle) and after 2 weeks (on day 17 of the cycle) post PEG-ASP dose.
    Cycle 6: before drug administration (on day 8 of the cycle) and after 1 week (on day 15 of the cycle) post PEG-ASP dose.
    Durante i cicli di terapia 5 e 6:
    Ciclo 5: prima della somministrazione del farmaco (il giorno 3 del ciclo), dopo 1 settimana (il giorno 10 del ciclo) e dopo due settimane (il giorno 17 del ciclo) dopo la somministrazione della dose di PEG-ASP.
    Ciclo 6: prima della somministrazione del farmaco (il giorno 8 del ciclo) e dopo 1 settimana (il giorno 15 del ciclo) dopo la somministrazione della dose di PEG-ASP.
    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 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.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) Yes
    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 concerned14
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 52
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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 Decision2019-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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