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    Summary
    EudraCT Number:2014-000200-10
    Sponsor's Protocol Code Number:GFM-DAC-CMML
    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:2014-09-17
    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 number2014-000200-10
    A.3Full title of the trial
    A Randomized Phase III study of Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)

    STUDIO RANDOMIZZATO DI FASE III CON DECITABINA CON O SENZA IDROSSIUREA VS IDROSSIUREA DA SOLA IN PAZIENTI CON CMML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Decitabine with or without Hydroxyurea in people with with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)
    STUDIO CON DECITABINA CON O SENZA IDROSSIUREA VS IDROSSIUREA DA SOLA IN PAZIENTI CON CMML
    A.4.1Sponsor's protocol code numberGFM-DAC-CMML
    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 Italiana Sindromi Mielodisplastiche (FISM 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 supportJanssen-Cilag
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Sindromi Mielodisplastiche (FISM Onlus)
    B.5.2Functional name of contact pointSegreteria FISM
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number390131206294
    B.5.5Fax number390131263455
    B.5.6E-mailsegreteriafismonlus@ospedale.al.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 DACOGEN
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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/3/06/370
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 RoleComparator
    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 Oncocarbide
    D.2.1.1.2Name of the Marketing Authorisation holderTEOFARMA Srl
    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 nameHydroxyurea
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule
    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 INNHYDROXYCARBAMIDE
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Proliferative Chronic Myelomonocytic Leukemia (CMML)
    CMML
    E.1.1.1Medical condition in easily understood language
    Chronic Myelomonocytic Leukemia
    CMML
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054350
    E.1.2Term Chronic myelomonocytic 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
    To compare between both arms the Event-free Survival (EFS).
    Events will include
    -Death from any cause
    -Transformation to AML according to WHO criteria : >20% circulating blasts or ≥ 20% bone marrow blasts (and, for marrow blasts, representing a ≥ 50% increase)
    -Progression of myeloproliferation defined as
    (i) ≥ 50% increase in spleen size (determined by an imaging method) or doubling in WBC (despite optimal HY or DAC dosing, in the absence of concomitant infection)
    (ii) Occurring or persisting after at least 3 cycles of DAC or HY
    Confrontare tra i due bracci l’EFS
    Gli eventi comprenderanno
    - Morte per qualsiasi causa
    - Trasformazione in LAM secondo i criteri WHO: >20% di blasti nel sangue periferico o ≥ 20% blasti midollari (e, per i blasti midollari, si tratta di un incremento ≥ 50%)
    - Progressione della mieloproliferazione definita come
    (i) incremento ≥ 50% delle dimensioni della milza (determinato tramite ecografia) o raddoppiamento dei WBC (nonostante la dose ottimale di HY o DAC, in assenza di infezioni concomitanti)
    (ii) Manifestazione o persistenza dopo almeno 3 cicli di DAC o HY
    E.2.2Secondary objectives of the trial
    To compare between the two arms:
    •Overall Survival
    •Cumulative AML progression
    •Overall and Complete Response Rates at 3 and 6 cycles
    •Response duration
    •Toxicity (hematological and non hematological)
    •Health Care Resource usage
    •Prognostic factors of response and overall survival with DAC and HY, using in particular:
    -The Spanish-Italian, the German and the French published prognostic scores
    -Somatic mutations
    Confrontare tra i due bracci:
    • Sopravvivenza totale
    • Progressione in LAM
    • Il numero di risposte totali e complete al ciclo 3 e 6
    • Durata della risposta
    • Tossicità (ematologica e non ematologica)
    • Utilizzo delle risorse sanitarie
    • Fattori prognostici di risposta e sopravvivenza con DAC e HY, usando in particolare:
    • Gli score prognostici italo-spagnoli, tedeschi e francesi pubblicati
    • Mutazioni somatiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- age 18 and older
    2- CMML as defined by:
    - Diagnosis according to WHO criteria
    -Stable excess in blood monocytes, > 1 Giga/L
    -Lack of bcr-abl rearrangement (or Philadelphia chromosome)
    -Bone marrow blast cells < 20%
    -Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation.
    And
    - WBC ≥ 13 G/L
    And
    - At least two of the following criteria: (adapted from Wattel et al. Blood 1996)
    -Marrow blasts ≥5 %
    -Clonal cytogenetic abnormality other than t(5;12) (q33; p13) and loss of Y chromosome
    -ANC > 16 G/l in the absence of an active infection
    -Anemia (Hb < 10 g/dL)
    -Thrombocytopenia (platelet count < 100 G/L)
    -Splenomegaly > 5 cm below costal margin (spleen size should also be measured by an imaging technique)
    Or: Extramedullary localization (including documented cutaneous, pleural or pericardial effusion)
    3- No prior treatment (except supportive care, or ESA, or short term (< 6 weeks) HY in patients presenting with high WBC counts)
    4- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
    5- Adequate organ function including the following
    -Liver : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or due to Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
    -Renal : serum creatinine < 2 times ULN
    6- Signed informed consent
    7- Negative pregnancy and adequate contraception (including in male patients) if relevant.
    1- Età > 18 anni
    2- CMML definita da:
    - Diagnosi secondo i criteri WHO
    - stabile eccesso di monociti nel sangue periferico, > 1 Giga/L
    - perdita del riarrangiamento bcr-abl (o cromosomaPhiladelphia )
    - blasti midollari < 20%
    - Dysplasia di almeno una linea o clonalità del marker o monocitosi del sangue periferico persistente (più di 3 mesi) dovuta o meno ad altre cause.

    E
    - WBC ≥ 13 G/L
    E
    - almeno due dei seguenti criteri: (secondo Wattel et al. Blood 1996)
    - Blasti midollari ≥5 %
    - Anomalia citogenetica clonale diversa da t(5;12) (q33; p13) e perdita del cromosoma Y
    - ANC > 16 G/l in assenza di un’infezione attiva
    - Anemia (Hb < 10 g/dL)
    - Piastrinopenia (conta delle piastrine < 100 G/L)
    - Splenomegalia > 5 cm sotto il margine costale (determinato tramite ecografia )
    O: Localizzazione extramidollare (incluso il versamento documentato cutaneo, pleurico o pericardico)
    3- Nessun precedente trattamento (eccetto terapia di supporto o ESA, o brevi periodi di terapia (< 6 settimane) con HY in pazienti che presentano un elevato numero dei globuli bianchi)
    4- Performance status 0-2 secondo la scalaECOG
    5- Funzionalità degli organi adeguata, inclusi i seguenti:

    - Fegato : bilirubina totale < 1.5 volte sopra i limiti normali (ULN) (eccetto una moderata iperbilirubinemia non correlata dovuta ad un’emolisi intra midollare o alla sindrome di Gilbert, ALT e AST < 3 volte il limite normale
    - Rene : creatinina serica < 2 volte il limite normale

    6- Firma del consenso informato
    7- Test di gravidanza negativo e un’adeguata contraccezione (incluso nei pazienti maschi) se rilevante

    E.4Principal exclusion criteria
    -Myeloproliferative / myelodysplastic syndrome other than CMML
    -Patients eligible for allogeneic bone marrow transplantation with an identified donor
    -CMML with t(5 ;12) or PDGFR rearrangement that may be treated with imatinib
    -Pregnant or breastfeeding
    -Performance status > 2 on the ECOG Scale.
    -Serious concomitant systemic disorder, including active bacterial, fungal or viral infection that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the stud
    -Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
    Sindrome mieloproliferativa / mielodisplastica diversa dalla CMML
    - Pazienti elegibili a trapianto allogenico con un donatore identificato
    - CMML con t(5 ;12) o riarrangiamento PDGFR che può essere trattata con imatinib
    - Gravidanza o allattamento
    - Performance status > 2 secondo la scala ECOG
    - Seria malattia sistemica concomitante, inclusa infezione batterica, fungina o virale attiva che, a giudizio dello Sperimentatore, potrebbe compromettere la sicurezza del paziente e/o la sua idoneità a completare lo studio
    1. Tumore precedente (eccetto il carcinoma della cervice in situ, carcinoma basocellulare delimitato, o altri tumori se non attivi durante gli ultimi 3 anni.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is Event-Free Survival , defined as the time between study entry and the date of last visit or the date of the first event occurring.

    Events will include:

    -Death from any cause
    -Transformation to AML according to WHO criteria (>20% blasts in peripheral blood or bone marrow) and corresponding, for bone marrow, to an increase by at least 50% compared to bone marrow blast count at study entry. - Progression by myeloproliferation defined as ≥ 50% increase in spleen size by imaging technique measurement, or doubling in WBC compared to study entry, despite maximal HY or DAC dosing, after at least 4 cycles of treatment, in the absence of concomitant infection.

    All suspected events, notably progression of myeloproliferation, will be centrally reviewed by a Response Committee before patients are allowed to exit study.
    E.5 Endpoint(s)
    L’ End point principale dello studio è l’EFS, definito come il tempo tra l’entrata nello studio di un paziente e l’ultima visita prevista o la data del primo evento occorso.

    Gli eventi includono:
    - Morte per qualsiasi causa
    - Trasformazione in LAM secondo i criteri WHO: >20% di blasti nel sangue periferico o ≥ 20% blasti midollari (e, per i blasti midollari, si tratta di un incremento ≥ 50%)
    - Progressione della mieloproliferazione definita come
    (i) incremento ≥ 50% delle dimensioni della milza (determinato tramite ecografia) o raddoppiamento dei WBC (nonostante la dose ottimale di HY o DAC, in assenza di infezioni concomitanti)
    Tutti i casi sospetti, di progressione in LAM e di progressione della mieloproliferazione, prima di uscire dallo studio saranno revisati da un Comitato Centrale di Revisione dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The response rate will be evaluated after three and six cycles, according to IWG 2006 criteria
    Il tasso di risposta sarà valutato dopo 3 e 6 cicli secondo i criteri IWG 2006.
    E.5.2Secondary end point(s)
    Overall Survival (OS), defined as the time between study entry and the date of last visit or death.

    Cumulative incidence of AML, according to WHO criteria (>20% blasts in peripheral blood or bone marrow), and corresponding to an increase by at least 50% compared to peripheral and bone marrow blast count at study entry.

    Overall and Complete Response Rates at 3 and 6 cycles according to IWG 2006 criteria
    • Overall Survival (OS), definito come il tempo trascoso tra l’entrata in studio e la data dell’ultima visita o il decesso.
    • Incidenza cumulativa delle LAM, secondo I criteri WHO (>20% di blasti nel sangue periferico o midollo), e un corrispondente aumento almeno del 50% paragonato alle conte del sangue periferico e del midollo osservate al momento dell’entrata nello studio.
    • Il tasso delle risposte complete e delle risposte totali a 3 e 6 cicli secondo i criteri IWG del 2006.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Overall Survival
    - Cumulative incidence of AML
    - Overall and Complete Response Rates
    • Overall Survival
    • Incidenza Cumulativa di LAM
    • Tasso di Risposte totali e complete
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 trial2
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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 No
    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) Yes
    F.1.2.1Number of subjects for this age range: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    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)
    none
    nessuno
    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 Decision2014-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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