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    Summary
    EudraCT Number:2020-001165-36
    Sponsor's Protocol Code Number:FLORENCE_CC-486_HRMDS
    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:2021-02-10
    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 number2020-001165-36
    A.3Full title of the trial
    A Phase 2, Monocentric, Pilot Study to evaluate safety and efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as maintenance of response to sc azacitidine in IPSS higher risk elderly MDS patients
    Studio pilota, di fase 2, monocentrico, che si propone di valutare l’efficacia e la sicurezza dell’azacitidina orale (CC-486), somministrata insieme alla miglior terapia di supporto, come trattamento di mantenimento della risposta alla azacitidina sc in soggetti anziani con SMD e con livelli di rischio IPSS più elevati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Monocentric, Pilot Study to evaluate safety and efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as maintenance of response to sc azacitidine in IPSS higher risk elderly MDS patients
    Studio pilota, di fase 2, monocentrico, che si propone di valutare l’efficacia e la sicurezza dell’azacitidina orale (CC-486), somministrata insieme alla miglior terapia di supporto, come trattamento di mantenimento della risposta alla azacitidina sc in soggetti anziani con SMD e con livelli di rischio IPSS più elevati
    A.3.2Name or abbreviated title of the trial where available
    FLORENCE_CC-486_HRMDS
    FLORENCE_CC-486_HRMDS
    A.4.1Sponsor's protocol code numberFLORENCE_CC-486_HRMDS
    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 SponsorDipartimento di Medicina Sperimentale e Clinica- Università di Firenze
    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 supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina Sperimentale e Clinica
    B.5.2Functional name of contact pointValeria Santini
    B.5.3 Address:
    B.5.3.1Street AddressLargo Brambilla 3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number0557947296
    B.5.6E-mailvaleria.santini@unifi.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 No
    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 nameAzacitidina Orale
    D.3.2Product code [CC-486]
    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 INNAZACITIDINA
    D.3.9.1CAS number 320-67-2
    D.3.9.2Current sponsor codeIMP 1
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeagente antineoplastico, analogo della pirimidina
    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
    IPSS and IPSS-R higher Risk ( INT-2 and High risk IPSS; Intermediate, high and very high risk IPSS-R) elderly Myelodysplastic syndrome (MDS) patients
    Pazienti anziani con Sindrome Mielodisplastica (SMD) ad alto rischio secondo IPSS e IPSS-R (INT-2 e alto rischio secondo IPSS; intermedio, alto, molto alto secondo R-IPSS)
    E.1.1.1Medical condition in easily understood language
    IPSS and IPSS-R higher Risk ( INT-2 and High risk IPSS; Intermediate, high and very high risk IPSS-R) elderly Myelodysplastic syndrome (MDS) patients
    Pazienti anziani con Sindrome Mielodisplastica (SMD) ad alto rischio secondo IPSS e IPSS-R (INT-2 e alto rischio secondo IPSS, con livello di rischio intermedio, alto, molto alto secondo R-IPSS
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the feasibility of replacing sc azacitidine by the oral formulation CC-486, in patients responding to sc azacitidine.
    In this context, “feasibility” encompasses 3 main areas of objective assessment:
    - Maintenance or improvement of response to therapy after switching from sc azacitidine to (oral) CC-486,
    - Safety and tolerability of CC-486,
    - Patient Reported Outcomes regarding satisfaction with the oral regimen
    Esplorare la fattibilità della sostituzione della azacitidina somministrata per via sc con la formulazione orale CC-486, in pazienti che rispondono alla azacitidina sc.
    In questo contesto, la fattibilità verrà valutata attraverso il:
    - Mantenimento o miglioramento della risposta alla terapia dopo il passaggio da sc azacitidina a (orale) CC-486,
    - Sicurezza e tollerabilità di CC-486,
    - Risultati riportati dal paziente riguardo alla soddisfazione con il regime orale
    E.2.2Secondary objectives of the trial
    - Response duration (CR/PR/HI) on CC-486
    - Progression to acute myeloid leukemia (AML), and time to AML progression;
    - Progression free survival
    - Overall survival
    - Exploratory Objectives: measure modifications of the pattern of DNA methylation levels ( by ERRBS technique) during cc 486 treatment as compared with those evaluated at the moment of cessation of azacitidine sc administration.
    - Durata della risposta (CR / PR / HI) su CC-486
    - Progressione alla leucemia mieloide acuta (LAM) e tempo alla progressione della LAM;
    - Sopravvivenza libera da progressione
    - Sopravvivenza globale
    - Obiettivi esplorativi: Determinare il mantenimento dei livelli di metilazione del DNA (mediante la tecnica ERRBS) rispetto a quelli valutati al momento della sospensione della somministrazione di azacitidina sc.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria to be enrolled in the study:
    1. Male or female subjects = 65 years of age at the time of signing the ICD;
    2. Diagnosed, histologically confirmed at inclusion,
    - Int-2 or High according to IPSS, or
    - Very High, High or Intermediate according to IPSS-R, or
    - Hypoplastic AML (20-30% BM blasts, previosuly considered MDS RAEB-T)
    - myelodysplastic CMML (included in IPSS scoring, WBC < 13.x 109/L);
    3. Should have undergone therapy with subcutaneous azacitidine for at least 4-6 cycles
    ( + 2 cycles)
    4. Must have achieved CR/CRi, PR or SD with HI status, as evidenced by IWG Criteria 2006 ( APPENDIX E):
    5. ECOG performance status of 0, 1, 2 (Appendix C);
    6. Adequate bone marrow function based on ANCs = 1.0 x 109/L and platelet counts = 70 x 109/L.
    7. Adequate organ function, defined as:
    Serum bilirubin =1.5 times the upper limit of normal (ULN);
    Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times the ULN;
    Serum creatinine = 2.5 times the ULN;
    8.Male subjects with a female partner of childbearing potential must agree to practice abstinence or to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine;
    10. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted;
    11. Able to adhere to the study visit schedule and other protocol requirements;
    12. Ability to swallow study medication.
    I soggetti devono soddisfare i seguenti criteri per essere iscritti allo studio:
    1. soggetti maschi o femmine di età = 65 anni al momento della firma dell'ICD;
    2. Diagnosi, istologicamente confermata al momento dell'inclusione,
    - Int-2 o High secondo IPSS, oppure
    - Molto alto, alto o intermedio (>3.5) secondo IPSS-R, oppure
    - LAM ipoplastica (20-30% di blasti, precedentemente considerato MDS RAEB-T)
    - CMML mielodisplastica (incluso nel punteggio IPSS, WBC <13.x 109 / L);
    3. soggetto sottoposto a terapia con azacitidina sottocutanea per almeno 4-6 cicli (+ 2 cicli)
    4. raggiungimento di CR / CRi, PR o SD con stato HI, come evidenziato dai criteri IWG 2006 (APPENDICE E)
    5. ECOG di 0, 1, 2 (Appendice C);
    6. Adeguata funzione midollare basata su ANC = 1,0 x 109 / La conta piastrinica
    = 70 x 109 / L.
    7. Funzione d'organo adeguata, definita come:
    Bilirubina sierica = 1,5 volte il limite superiore della norma (ULN);
    Siero aspartato transaminasi(AST) e alanina aminotransferasi (ALT) =2,5 volte l'ULN;
    Creatinina sierica = 2,5 volte l'ULN;
    8. I soggetti di sesso maschile con un partner femminile in età fertile devono concordare di praticare l'astinenza o l'uso di un metodo contraccettivo approvato dal medico durante il corso dello studio ed evitare di generare un figlio durante il corso dello studio e per i 3 mesi successivi alla ultima dose di azacitidina;
    10. Comprendere e firmare volontariamente un consenso informato prima di condurre qualsiasi valutazione / procedura relativa allo studio;
    11. In grado di aderire al programma delle visite di studio e ad altri requisiti del protocollo;
    12. Capacità di deglutire i farmaci di studio.
    E.4Principal exclusion criteria
    - Absence of confirmed hematological response ( IWG HI/PR/CR) after at least 4 to 6 months of azacitidine sc and maintenance of response for 2 additional cycles.
    - Inability to provide a valid informed consent.
    - Eligibility for HSCT
    - Active infection
    - Serum creatinine > 2 x ULN at screening.
    - ECOG performance status > 2
    - Left ventricular ejection fraction < 50% by echocardiography
    - A history of repeated hospitalization for severe infections Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
    - Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of chronic hepatitis follows EASL 2017 criteria).
    - History of HIV positive test result (ELISA or Western blot).
    - ALT or AST over 3 times superior to ULN at screening.
    - Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study)
    - Patients participating in another clinical trial other than an observational registry study.
    - Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
    - History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
    - Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug.
    - History of drug or alcohol abuse within the 12 months prior to enrollment.
    - Assenza di risposta ematologica confermata (IWG HI / PR / CR) dopo almeno 4- 6 mesi di azacitidina sc e mantenimento della risposta per 2 cicli aggiuntivi.
    - Impossibilità a fornire un consenso informato valido.
    - Eligibilità per trapianto di cellule staminali
    - Infezione attiva
    - Creatinina sierica> 2 x ULN allo screening.
    - ECOG> 2
    - Frazione di eiezione ventricolare sinistra <50% mediante ecocardiografia
    - Una storia di ricovero ripetuto per infezioni gravi Malattie sistemiche che impedirebbero il trattamento in studio (ad es. Ipertensione non controllata, cardiovascolare, renale, epatica, metabolica, ecc.)
    - Evidenza clinica o di laboratorio di epatite B cronica o epatite C (definizione di 'epatite cronica segue i criteri EASL 2017).
    - HIV positivo (ELISA o Western blot).
    - ALT o AST oltre 3 volte superiori a ULN allo screening.
    - Bilirubina totale oltre 1,5 volte superiore all'ULN allo screening (i pazienti con sindrome di Gilbert possono entrare nello studio)
    - Pazienti che partecipano a un'altra sperimentazione clinica diversa da uno studio del registro osservazionale.
    - Pazienti con anamnesi di un'altra neoplasia negli ultimi 3 anni, ad eccezione del carcinoma basale della pelle o del carcinoma cervicale in situ o del carcinoma del polipo colico completamente resecato in situ.
    - Storia di non conformità a regimi medici o pazienti considerati potenzialmente inaffidabili e / o non cooperativi.
    - Presenza di una condizione chirurgica o medica che potrebbe alterare in modo significativo l'assorbimento, la distribuzione, il metabolismo o l'escrezione del farmaco in studio.
    - Storia di abuso di droghe o alcol nei 12 mesi precedenti l'iarruolamento
    E.5 End points
    E.5.1Primary end point(s)
    -To determine maintenance of CR/CRi, PR or SD with HI
    -To determine Safety/ tolerability (type, frequency, severity, and relationship of AEs to study treatments; physical examinations, vital signs; clinical laboratory evaluations, and concomitant medication/therapy);
    -To determine the effect of CC 486 on health-related quality-of-life (HRQoL) by Patient-reported outcomes utilizing the EQ-5D
    - determinare il mantenimento di CR / CRi, PR o SD con HI
    - determinare la sicurezza / tollerabilità (tipo, frequenza, gravità e relazione degli eventi avversi al trattamento in studio; esami fisici, segni vitali; valutazioni di laboratorio cliniche e terapia / terapia concomitante);
    - determinare l'effetto del CC 486 sulla qualità della vita correlata alla salute (HRQoL) in base ai risultati riportati dal paziente utilizzando l'EQ-5D
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    -Time to relapse from CR/CRi, PR, SD with HI; -Time to discontinuation from treatment; Exploratory endpoints
    -to determine the presence of differentially methylated regions (DMRs) at baseline, and verify DMRs and modulation of the pattern of methylation during treatment. Then, transcriptional profile and correlation between expression and methylation will be investigated.
    -Tempo di perdita della risposta( CR / CRi, PR, SD con HI); -Tempo alla sospensione dal trattamento; Endpoint esplorativi
    -per determinare la presenza di regioni differenziate metilate (DMR) al basale e verificare le DMR e la modulazione del modello di metilazione durante il
    trattamento. Quindi, verranno studiati il profilo trascrizionale e la correlazione tra espressione e metilazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months; 24 months; 24 months
    24 mesi; 24 mesi; 24 mesi
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Yes
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    All subjects who have received at least one dose of CC-486 should undergo Treatment Discontinuation procedures when treatment is discontinued (AEs, monitoring for progression of MDS and SPM, physical examination, vital signs and weight measurements, ECOG performance status, hematology and serum blood chemistry, serum ferritin level, concomitant medications, therapies and procedures, transfusions administered, disease status assessment, subsequent AML therapies, CC-486 accountability, HRQoL)
    Tutti i soggetti che hanno ricevuto almeno una dose di CC-486 devono essere sottoposti a Procedure di Interruzione del trattamento quando questo viene interrotto (AE, monitoraggio della progressione di SMD e SPM, esame fisico, segni vitali e misurazioni del peso, ECOG, esami ematochimici, livello di ferritina sierica, farmaci, terapie e procedure concomitanti, trasfusioni somministrate, valutazione dello stato di malattia, terapie AML successive, CC-486 accountability, HRQoL)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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