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    Summary
    EudraCT Number:2020-003912-28
    Sponsor's Protocol Code Number:ALL2620
    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:2021-06-15
    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 number2020-003912-28
    A.3Full title of the trial
    Ponatinib for the management of minimal residual disease (MRD) and hematologic relapse in adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients.
    Ponatinib per la gestione della Malattia Minima Residua (MMR) e la recidiva ematologica in pazienti adulti affetti da Leucemia Linfoblastica Acuta Ph+(Ph+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 evaluate the efficacy of Ponatinib, either alone or in combination with chemotherapy, in inducing remission in patients: MRD positive (persistent or relapsed), patients after haematological and extra-haematological relapse and patients who do not have never achieved remission after any previous treatment.
    Lo scopo dello studio è quello di valutare l’efficacia del Ponatinib, in monoterapia o in combinazione con chemioterapia, nell’indurre una remissione in pazienti: MRD positivi (persistenti o recidivi), pazienti dopo ricaduta ematologica ed extra-ematologica e pazienti che non hanno mai raggiunto remissione dopo qualsiasi trattamento precedente.
    A.3.2Name or abbreviated title of the trial where available
    ALL2620
    ALL2620
    A.4.1Sponsor's protocol code numberALL2620
    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 supportIncyte Biosciences International Sàrl
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportFondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Gimema
    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 Iclusig 15 mg compresse rivestite con film
    D.2.1.1.2Name of the Marketing Authorisation holderIncyte Biosciences Distribution B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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/3/09/715
    D.3 Description of the IMP
    D.3.1Product nameIclusig
    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 INNPonatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePonatinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Ph+ Acute Lymphoblastic Leukemia
    Leucemia Linfoblastica Acuta Ph+
    E.1.1.1Medical condition in easily understood language
    Acute lymphoblastic leukemia is a blood cancer that originates from lymphocytes (white blood cells) and is characterized by an accumulation of these cells in the blood, bone marrow and other organs.
    La leucemia linfoblastica acuta è un tumore del sangue che origina dai linfociti (globuli bianchi) ed è caratterizzata da un accumulo di queste cellule nel sangue, nel midollo osseo e in altri organi.
    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 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    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 this study is to evaluate the rate of patients obtaining a MRD negativity/MRD reduction following treatment with either ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment. Since both MRD+ and hematologically and extra-hematologically relapsed/refractory patients will be considered, the primary objective will be analyzed separately in the two groups of MRD+ and hematologically and extra-hematologically relapsed/refractory patients.
    L’obiettivo primario di questo studio è quello di valutare il tasso di pazienti che ottengono una negatività/riduzione della MMR dopo tre mesi di trattamento con ponatinib, in monoterapia o in combinazione con chemioterapia sistemica. Dal momento che verranno considerati sia i pazienti in recidiva ematologica ed extra-ematologica o refrattari che quelli MMR+, l’obiettivo primario sarà analizzato separatamente per le due categorie di pazienti.
    E.2.2Secondary objectives of the trial
    1. The duration of CMR, if achieved.
    2. The achievement of an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease.
    3. The best molecular response.
    4. Safety profile.
    5. Mutational analysis.
    6. The correlation between biological and MRD parameters.
    7. Disease-free survival (DFS).
    8. Overall Survival (OS).
    9. Cumulative Incidence of relapse (CIR).
    10. Role of clinical and biological parameters on survival outcome.
    1. Durata di remissione completa, se ottenuta.
    2. Ottenimento di una remissione ematologica nei pazienti trattati per recidiva ematologica ed extra-ematologica e per malattia refrattaria.
    3. Migliore risposta molecolare.
    4. Profilo di sicurezza.
    5. Analisi mutazionale.
    6. Correlazione tra parametri biologici e MMR.
    7. Disease-free survival (DFS).
    8. Overall survival (OS).
    9. Cumulative incidence of relapse (CIR).
    10. Ruolo di parametri clinici e biologici sulla sopravvivenza.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Translational Research v1.0 del 19.02.2020

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Ricerca Traslazionale v.1.0 del 19.02.2020
    E.3Principal inclusion criteria
    1. Ph+ ALL patients with evidence of MRD disease or in hematologic and extra-hematologic relapse/refractoriness after any previous treatment, will be considered eligible to enter the study.
    2. Age =18 years old with no upper age limit.
    3. Adequate hepatic function as defined by the following criteria:
    - total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
    - alanine aminotransferase (ALT) =2.5 × ULN
    - aspartate aminotransferase (AST) =2.5 × ULN.
    4. Adequate pancreatic function as defined by the following criterion: - serum lipase and amylase =1.5 × ULN.
    5. For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
    6. Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.
    7. Signed written informed consent according to ICH/EU/GCP and national local laws.
    1. Saranno considerati eleggibili i pazienti Ph+ ALL con evidenza di MMR+ o i pazienti in recidiva ematologica ed extra-ematologica o refrattari dopo qualsiasi trattamento precedente.
    2. Pazienti con età =18 anni.
    3. Funzionalità epatica adeguata come definita dai seguenti criteri:
    - bilirubina sierica totale =1.5 x ULN, eccetto se dovuta alla sindrome di Gilbert
    - alanina aminotransferasi (ALT) =2.5 × ULN
    - aspartato aminotransferasi (AST) =2.5 × ULN
    4. Funzionalità pancreatica adeguata come definita dal seguente criterio:
    - lipase ed amilasi sierica =1.5 × ULN.
    5. Per le donne potenzialmente fertili, un test di gravidanza negativo deve essere documentato prima dell’arruolamento.
    6. Le donne e gli uomini fertili devono accettare l’utilizzo di un metodo di contraccezione efficace dal momento dell’arruolamento fino a 4 mesi dopo la fine del trattamento.
    7. Firma del consenso informato scritto in accordo alle normative ICH/EU/GCP e le leggi nazionali.
    E.4Principal exclusion criteria
    1. WHO performance status = 50% (Karnofsky) or = 3 (ECOG).
    2. Uncontrolled active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN not due to the disease.
    3. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
    4. History of alcohol abuse.
    5. Ongoing or active uncontrolled infections.
    6. Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
    7. Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
    - any history of myocardial infarction, stroke, or revascularization
    - unstable angina or transient ischemic attack within 6 months prior to enrollment
    - congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment
    - history of clinically significant (as determined by the treating physician) atrial arrhythmia
    - any history of ventricular arrhythmia
    - any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
    - uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
    8. Taking medications that are known to be associated with Torsades de Pointes.
    9. Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
    10. Creatinine level >2.5mg/dl or glomerular filtration rate (GFR) <20 ml/min or proteinuria >3.5 g/day.
    11. Patients who are currently receiving treatment with any of the medications listed in Appendix E if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT.
    1. WHO performance status =50% (Karnofsky) o =3 (ECOG).
    2. Epatiti HBV o HCV attive, o AST/ALT =2.5 x ULN e bilirubina =1.5 x ULN.
    3. Storia di pancreatite acuta entro un anno dallo studio o storia di pancreatite cronica.
    4. Storia di abuso di alcol.
    5. Infezioni attive o in corso.
    6. Ipertrigliceridemia non controllata (trigliceridi >450 mg/dL).
    7. Patologia cardiovascolare clinicamente significativa attiva o non controllata, inclusa in particolare, ma non limitatamente a:
    - storia di infarto del miocardio, ictus o rivascolarizzazione
    - angina instabile o attacco ischemico transitorio entro 6 mesi prima dell'arruolamento
    - insufficienza cardiaca congestizia entro 6 mesi prima dell'arruolamento o frazione di eiezione ventricolare sinistra minore al limite inferiore della norma secondo gli standard istituzionali locali entro 6 mesi prima dell’arruolamento
    - storia di aritmia atriale clinicamente significativa (determinata dal medico curante) e non controllata
    - storia di aritmia ventricolare
    - storia di tromboembolia venosa inclusa trombosi venosa profonda o embolia polmonare
    - ipertensione non controllata (pressione sanguigna diastolica >90 mmHg; sistolica >140 mmHg). I pazienti con ipertensione dovrebbero essere in trattamento all'ingresso nello studio per effettuare il controllo della pressione sanguigna
    - storia o presenza di malattia occlusiva dell'arteria periferica
    8. Assunzione di farmaci noti per essere associati a Torsades de Pointes.
    9. Assunzione di farmaci o integratori a base di erbe noti per essere potenti inibitori del CYP3A4 entro almeno 14 giorni prima della somministrazione di ponatinib.
    10. Livelli di Creatinina >2.5mg/dl o Glomerular Filtration Rate (GFR) <20 ml/min o proteinuria>3.5g/day.
    11. Pazienti che stanno ricevendo un trattamento con uno dei farmaci elencati nell’Appendice E se la terapia non può essere interrotta o modificata ad un farmaco differente prima di iniziare il farmaco in studio. I farmaci elencati nell’Appendice E sono associati al prolungamento del QT.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of patients who achieve a MRD negativity/MRD reduction following treatment with either Ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment.
    L'endpoint primario è il tasso di pazienti che ottengono una riduzione/ negativizzazione della MRD dopo il trattamento con Ponatinib da solo o in combinazione con chemioterapia sistemica dopo 3 mesi di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 3 months of treatment
    Dopo 3 mesi di trattamento
    E.5.2Secondary end point(s)
    1. Duration of CMR, if applicable.
    2. Rate of patients who achieve an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease.
    3. The best molecular response achieved during the study.
    4. Safety profile in terms of incidence of grade >3 CTC-NCI side effects and toxicities (AE/SAEs).
    5. Mutational analysis in terms of occurrence, type and number of BCR-ABL1 kinase domain mutations.
    6. Correlation between the achievement and duration of CMR (or MRD reduction) with the type of fusion protein (e.g. p190 or p210) and the potential occurrence of mutations, as well as with additional genomic lesions.
    7. DFS at 24 months.
    8. OS at 24 months.
    9. CIR at 24 months.
    10. Role of clinical and biological assessment at baseline, type of fusion protein (p190 vs p210) and presence of additional genomic lesions and mutations, duration on CMR, OS and DFS.
    1. Durata del CMR, se applicabile.
    2. Tasso di pazienti che ottengono una remissione ematologica nei pazienti trattati per una recidiva ematologica ed extra-ematologica e per una malattia refrattaria.
    3. La migliore risposta molecolare ottenuta durante lo studio.
    4. Profilo di sicurezza in termini di incidenza di effetti collaterali e tossicità CTC-NCI di grado> 3 (EA / SAE).
    5. Analisi mutazionale in termini di occorrenza, tipo e numero di mutazioni nel dominio della chinasi BCR-ABL1.
    6. Correlazione tra il raggiungimento e la durata della CMR (o riduzione della MRD) con il tipo di proteina di fusione (es. P190 o p210) e la potenziale comparsa di mutazioni, nonché con ulteriori lesioni genomiche.
    7. DFS a 24 mesi.
    8. OS a 24 mesi.
    9. CIR a 24 mesi.
    10. Ruolo della valutazione clinica e biologica al basale, tipo di proteina di fusione (p190 vs p210) e presenza di ulteriori lesioni genomiche e mutazioni, durata su CMR, OS e DFS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the beginning and at the end of the study.
    All'inizio e 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 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 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) 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 concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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 months11
    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 months11
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 67
    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 the normal care activity provided bygood 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
    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 Decision2021-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusOngoing
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