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    Summary
    EudraCT Number:2015-001102-34
    Sponsor's Protocol Code Number:CML1315
    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:2021-06-08
    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 number2015-001102-34
    A.3Full title of the trial
    Optimizing Ponatinib USe (OPUS). Studio GIMEMA di fase 2 sull¿efficacia e sul profilo di rischio di ponatinib, 30 mg al giorno, in pazienti con Leucemia Mieloide Cronica (LMC) in Fase Cronica, resistenti all¿Imatinib.
    Optimizing Ponatinib USe (OPUS). A GIMEMA phase 2 study of the activity and risk profile of ponatinib, 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to imatinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A GIMEMA study to evaluate the safety and efficacy of the drug, called ponatinib, which is administrated at 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to another drug called imatinib
    Studio per valutare la sicurezza e l'efficacia di un farmaco denominato ponatinib, sommministrato alla dose di 30 mg al giorno, a pazienti con Leucemia Mieloide Cronica (LMC) in Fase Cronica che gi¿ hanno assunto un altro farmaco denominato Imatinib che non ha mostrato l'efficacia attesa.
    A.3.2Name or abbreviated title of the trial where available
    NA
    CML1315
    A.4.1Sponsor's protocol code numberCML1315
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02398825
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 supportARIAD Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportA.I.L. Associazione Italliana 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 GIMEMA onlus Franco Mandelli
    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 number+390670390526
    B.5.5Fax number+390670390540
    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 - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE 60 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderARIAD PHARMA LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/09/716
    D.3 Description of the IMP
    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.3.10 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
    Chronic Myeloid Leukemia (CML) in Chronic Phase (CP)
    Leucemia Mieloide Cronica (LMC) in Fase Cronica,
    E.1.1.1Medical condition in easily understood language
    Chronic Myeloid Leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. In CML, a genetic change takes place in a early (immature) version of myeloid cells- t
    La leucemia mieloide cronica (LMC) ¿ una forma di cancro che ha origine dalle cellule di midollo osseo che rappresentano i precursori delle cellule del sangue (piastrine, globuli rossi e globuli bianc
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10009013
    E.1.2Term Chronic myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to assess the activity of second-line ponatinib in CP-CML patients resistant to
    imatinib.
    L¿obiettivo primario dello studio ¿ valutare l¿attivit¿ del Ponatinib in seconda linea in pazienti con LMC in fase cronica resistenti all¿Imatinib.
    E.2.2Secondary objectives of the trial
    1. to evaluate the safety and the side effects of an initial dose of 30 mg once daily;
    2. to investigate if genetic polymorphisms, cytokines profile and haemostatic alterations affect
    the occurrence of cardiovascular adverse events;
    3. to evaluate the feasibility and the activity of ponatinib dose adjustments, guided by
    molecular response;
    4. to assess the dynamics of CyR, the depth and the dynamics of molecular response;
    5. to investigate the evolution of BCR-ABL1 KD point mutations, assessed by Ultra Deep
    Sequencing (UDS);
    6. to estimate Failure-Free Survival (FFS)
    7. to estimate Progression-Free Survival (PFS);
    8. to estimate Overall Survival (OS);
    9. to estimate Event-Free Survival (EFS);
    10. To assess Quality of Life (QoL)
    1. valutare la sicurezza e gli effetti collaterali di una dose iniziale di 30 mg una volta al giorno;
    2. studiare la possibilit¿ che i polimorfismi genetici, il profilo di espressione delle citochine e le alterazioni dell¿emostasi incidano sulla manifestazione di eventi avversi cardiovascolari;
    3. valutare la fattibilit¿ e l¿attivit¿ dell¿aggiustamento del dosaggio di ponatinib, sulla base della risposta molecolare;
    4. valutare la dinamica della CyR, la profondit¿ e la dinamica della riposta molecolare;
    5. studiare l¿evoluzione delle mutazioni puntiformi del dominio BCR/ABL, valutata tramite Ultra Deep Sequencing (UDS);
    6. valutare la Failure Free Survival;
    7. valutare la Progression Free Survival;
    8. valutare la Overall Survival;
    9. valutare la Event Free Survival;
    10. valutare la qualit¿ di vita.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Life quality
    Version: 1.1
    Date: 11/08/2015
    null
    Objectives: Given the lack of preliminary patient-reported QoL data for CML patients treated with ponatinib QoL will be evaluated on an exploratory basis. Thus, the main objective is to describe patients' QoL over time from baseline up to 52 weeks.
    Secondary Objectives: To outline the baseline patients¿ QoL and symptom profile in relation to socio-demographic, clinical and laboratory values (cross-sectional analyses only). To investigate the prognostic value of baseline QoL and early QoL changes (i.e., from baseline to 4 week9 for FFS, OS, EFS and PFS so as defined in this protocol.

    Qualita' della vita
    Versione: 1.1
    Data: 11/08/2015
    Titolo: Quality of life assessment
    Obiettivi: Given the lack of preliminary patient-reported QoL data for CML patients treated with ponatinib QoL will be evaluated on an exploratory basis. Thus, the main objective is to describe patients' QoL over time from baseline up to 52 weeks.
    Secondary Objectives: To outline the baseline patients¿ QoL and symptom profile in relation to socio-demographic, clinical and laboratory values (cross-sectional analyses only). To investigate the prognostic value of baseline QoL and early QoL changes (i.e., from baseline to 4 week) for FFS, OS, EFS and PFS so as defined in this protocol.
    E.3Principal inclusion criteria
    1. Cytogenetic and/or molecular confirmed diagnosis of Ph+ and/or BCR-ABL1+ CML
    2.2. Age = 18 years and = 70 years old
    3. Chronic phase CML
    4. Prior treatment with Imatinib, any dose
    5. Resistance to imatinib, as defined by any one of the ELN 2013 failure criteria, as follows:
    ¿ no complete hematologic response (CHR) at 3 months
    ¿ no cytogenetic response (CyR) (Ph+ > 95%) at 3 months
    ¿ Less than partial CyR (PCyR, Ph+ > 35%) at 6 months
    ¿ BCR-ABL1 > 10% at 6 months
    ¿ Non complete CyR (CCyR) (Ph+ > 0%) at 12 months
    ¿ BCR-ABL1 > 1% at 12 months
    ¿ Loss of CHR at any time
    ¿ Loss of CCyR at any time
    ¿ Confirmed loss of major molecular response (MMR) (BCR-ABL1 ¿ 0.1% in two
    consecutive tests, of which one ¿ 1%) at any time
    ¿ Any new BCR-ABL1 mutation, at any time
    6. For females of childbearing potential, a negative pregnancy test must be documented prior
    to enrolment
    7. An effective form of contraception with their sexual partners from enrolment through 4
    months after the end of treatment
    8. Signed written informed consent according to ICH/EU/GCP and national local laws prior
    to any study procedures
    9. Willingness and ability to comply with scheduled visits and study procedures.
    Criteri di inclusione:
    1. conferma citogenetica e/o molecolare della diagnosi di LMC Ph+ e/o BCR-ABL1+;
    2. 2. età = 18 anni e = 70 anni;
    3. LMC in fase cronica;
    4. precedente trattamento con Imatinib, a qualsiasi dosaggio;
    5. resistenza ad Imatinib come definito da uno qualunque dei criteri di fallimento ELN 2013, in dettaglio:
    - assenza di risposta ematologica completa (CHR) a 3 mesi;
    - assenza di risposta citogenetica (CyR) (Ph+ > 95%) a 3 mesi;
    - risposta citogenetica inferiore alla risposta parziale (PCyR, Ph+ > 35%) a 6 mesi;
    - BCR-ABL1 > 10% a 6 mesi;
    - risposta citogenetica non completa (CCyR) (Ph+ > 0%) a 12 mesi;
    - BCR-ABL1 > 1% a 12 mesi;
    - perdita della CHR in qualsiasi momento;
    - perdita di CCyR in qualsiasi momento;
    - conferma della perdita della risposta molecolare maggiore (MMR) (BCR-ABL1 = 0.1% in due test consecutivi, dei quali uno = 1%), in qualsiasi momento;
    - qualsiasi nuova mutazione BCR-ABL1 in qualsiasi momento;
    6. per le donne potenzialmente fertili deve essere documentato un test di gravidanza negativo prima dell’arruolamento;
    7. utilizzo di un sistema di contraccezione efficace con i rispettivi partner sessuali dall’arruolamento fino a 4 mesi successivi alla fine del trattamento;
    8. modulo di consenso informato scritto in accordo alle ICH/EU/GCP e alle normative nazionali vigente precedentemente a qualsiasi procedura dello studio;
    9. disponibilità e capacità di ottemperare alle visite programmate e alle procedure dello studio.
    E.4Principal exclusion criteria
    1. Accelerated or blastic phase CML
    2. Patients previously treated with nilotinib or dasatinib
    3. Patients with the T315I mutation
    4. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis or
    of alcohol abuse
    5. Patients with history of acute myocardial infarction (AMI), or unstable angina or
    coronary heart disease (CHD), congestive heart failure, cerebrovascular events (CVE)
    (stroke or transitory ischemic attack), or peripheral artery occlusive disease (PAOD)
    6. Compelled to take medications that are known to be associated with Torsades de
    Pointes and/or with significant QTc prolongation
    7. Pregnant or breastfeeding;
    8. Any condition or illness that, in the opinion of the Investigator, would compromise patient
    safety or interfere with the evaluation of the drug
    9. Lack of informed consent
    1. LMC in fase accelerata o blastica;
    2. pazienti precedentemente trattati con nilotinib o dasatinib;
    3. pazienti con la mutazione T315I;
    4. storia di pancreatite acuta entro 1 anno dall’inizio dello studio o storia di pancreatite cronica o di abuso di alcool;
    5. pazienti con storia di infarto miocardico acuto (AMI), angina instabile o coronaropatia (CHD), insufficienza cardiaca congestizia, eventi cerebrovascolari (CVE) (ictus o attacco ischemico transitorio), o malattia occlusiva delle arterie periferiche (PAOD);
    6. obbligo ad essere sottoposto a trattamenti, di cui sia nota l’associazione con Torsades de Pointes e/o con una significativa sindrome del QT lungo;
    7. gravidanza o allattamento;
    8. qualsiasi condizione o malattia che, a discrezione dello sperimentatore, potrebbe compromettere la sicurezza del paziente o interferire con la valutazione del farmaco;
    9. ritiro del consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the activity of second-line ponatinib in CP-CML patients resistant to imatinib.
    Valutare l’attività del Ponatinib in seconda linea in pazienti con LMC in fase cronica resistenti all’Imatinib.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al termine dello studio
    E.5.2Secondary end point(s)
    1. the rate of the development of cardiovascular AEs (CVAEs), blood hypertension, and pancreatitis;
    2. The relationship of gene polymorphisms, cytokine prophile, and haemostatic profile with the
    development of CVAEs;
    3. The relationship of activity and safety data with ponatinib dosing in terms of:
    o the rate of CCyR (Ph+ 0, or BCR-ABL1+ < 1% by FISH) by 52 weeks;
    o the rate of Major Molecular Response (MMR, BCR-ABL1 ¿ 0.1%) by 52 weeks;
    o the rate of Early Molecular Response (EMR, BCR-ABL1 ¿ 10%) at 12 and 24 weeks;
    o the rate of confirmed MR4 and MR4.5 by 52 weeks;
    4. to assess the dynamics of CyR in terms of the time to response (to MCyR, CCyR, MMR, MR4, MR4.5);

    1. il tasso di insorgenza di eventi avversi cardiovascolari (EACV), ipertensione arteriosa, e pancreatite;
    2. La correlazione tra i polimorfismi genetici, il profilo delle citochine e il profilo emostatico con l¿insorgenza di EACV;
    3. La correlazione tra i dati di attivit¿ e sicurezza con il dosaggio di Ponatinib in termini di:
    - tasso di CCyR (Ph + 0, o BCR-ABL1 + <1% da FISH) a 52 settimane;
    - il tasso di risposta molecolare maggiore (MMR, BCR-ABL1 ¿ 0,1%) a 52 settimane;
    - il tasso di risposta molecolare precoce (EMR, BCR-ABL1 ¿ 10%) a 12 e 24 settimane;
    - il tasso di conferma MR4 e MR4.5 a 52 settimane;
    4. valutare le dinamiche della CyR, in termini di tempo di risposta (a MCyR, CCyR, MMR, MR4, MR4.5);
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al termine 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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualit¿ della vita
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other 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 concerned44
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA44
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    The patients will continue to be treated according to current clinical practice
    I pazienti continueranno ad essere trattati 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 G.I.M.EM.A. Gruppo Italiano Malattie EMatologiche dell'Adulto
    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 Decision2015-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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