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    Summary
    EudraCT Number:2014-001486-27
    Sponsor's Protocol Code Number:1301-LG
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    Trial results View 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 number2014-001486-27
    A.3Full title of the trial
    10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients ≥ 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group
    Confronto tra terapia con decitabina della durata di 10 giorni rispetto alla chemioterapia convenzionale (“3+7”) seguita da trapianto allogenico in pazienti con AML ≥ 60 anni: studio di fase III randomizzato del Leukemia Group di EORTC, CELG, GIMEMA e del gruppo di studio tedesco sulle SMD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients ≥ 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group
    Confronto tra terapia con decitabina della durata di 10 giorni rispetto alla chemioterapia convenzionale (“3+7”) seguita da trapianto allogenico in pazienti con AML ≥ 60 anni: studio di fase III randomizzato del Leukemia Group di EORTC, CELG, GIMEMA e del gruppo di studio tedesco sulle SMD
    A.4.1Sponsor's protocol code number1301-LG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02172872
    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 SponsorEuropean Orgainzation for the Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    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 supportEORTC
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisaton for the Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741054
    B.5.5Fax number+3227741030
    B.5.6E-mailregulatory@eortc.be
    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.2.5The 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.3.1Product nameDecitabine
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNDECITABINE
    D.3.9.1CAS number 2353-33-5
    D.3.9.4EV Substance CodeSUB06932MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.5The 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 nameDaunorubicin
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNDaunorubicin
    D.3.9.1CAS number 20830-81-3
    D.3.9.3Other descriptive nameDAUNORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01556MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number45 to 60
    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: 3
    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.2.5The 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 nameCytarabine
    D.3.4Pharmaceutical form Solution for injection/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 INNCytarabine
    D.3.9.1CAS number 147-94-4
    D.3.9.3Other descriptive nameCYTARABINE
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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: 4
    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.2.5The 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 nameIdarubicin
    D.3.4Pharmaceutical form 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 INNIdarubicin
    D.3.9.1CAS number 58957-92-9
    D.3.9.3Other descriptive nameIDARUBICIN
    D.3.9.4EV Substance CodeSUB08111MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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: 5
    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.2.5The 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 nameEtoposide
    D.3.4Pharmaceutical form Concentrate for 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 INNEtoposide
    D.3.9.1CAS number 33419-42-0
    D.3.9.3Other descriptive nameETOPOSIDE
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Acute Myeloid Leukaemia (AML) in elderly population (equal or older than 60 years).
    Leucemia mieloide acuta (AML) in popolazione anziana (uguale o più di 60 anni).
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukaemia (AML) in elderly population (equal or older than 60 years).
    Leucemia mieloide acuta (AML) in popolazione anziana (uguale o più di 60 anni).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10024291
    E.1.2Term Leukaemias acute myeloid
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLGT
    E.1.2Classification code 10024324
    E.1.2Term Leukaemias
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute 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 of this study is to assess, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (“3+7”) on overall survival (OS) in older AML patients.
    L'obiettivo primario di questo studio è di valutare, attraverso una sperimentazione randomizzata di fase III, l'effetto della terapia della durata di 10 giorni con decitabina alla dose di 20 mg/m2 rispetto alla chemioterapia di induzione convenzionale (“3+7”) sulla sopravvivenza globale (OS) in pazienti anziani affetti da leucemia mieloide acuta (AML).
    E.2.2Secondary objectives of the trial
    Between two treatment arms:
    ♦ To compare efficacy : complete response rate, response rate and disease-free survival (DFS) and progression-free survival (PFS)
    ♦ To compare safety and toxicity profile
    ♦ To determine feasibility of allogeneic hematopoietic cell transplantation with reduced intensity conditioning
    ♦ To determine transplant outcome in terms of disease free survival, incidence of non-relapse related mortality (NRM) and incidence of relapse
    ♦ To determine health/economic impact by of days staying in hospital and transfusion needs for selected sites
    ♦ To compare Quality of Life (QoL) of patients
    ♦ To determine impact of baseline physical and functional conditions
    ♦ To identify, by translational research, potential biomarkers which are of prognostic importance; in addition, in decitabine arm, identification of DNA methylation signature of response will be assessed
    ♦ To determine prognostic value of minimal residual disease (MRD) regarding risk of relapse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ♦Age ≥ 60 years
    ♦ WHO Performance status: ≤ 2
    ♦ Eligible for standard intensive chemotherapy
    ♦Patients of reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
    ♦ Have newly diagnosed AML that is cytopathologically confirmed according to WHO classification (Patients can be diagnosed with AML two months prior to randomization)
    ♦De novo or secondary AML is allowed
    WBC is ≤30x109/L (measured within 72 hours prior to randomization)
    ♦ The following laboratory assessments should be done within 7 days prior to randomization and should be within the following range:
    ♦ SGOT (AST) and SGPT (ALT) < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related
    ♦ Total serum bilirubin level < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related or due to Gilbert’s syndrome
    ♦ Serum creatinine concentration < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related
    ♦ The following treatments for previous MDS or MPN are allowed as long as treatment has stopped one month before inclusion:
    -Growth factors, thrombomimetics, immunosuppression (cyclosporin A, steroids, Antithymocyte globulin etc.), chelation, interferons, anagrelide
    -Lenalidomide, low-dose chemotherapy (low-dose melphalan, hydroxyurea, low-dose cytarabine etc.), tyrosine-kinase inhibitors, histone deacetylase inhibitors (e.g. Valproic acid, panobinostat etc.), mTOR inhibitors, other experimental treatment that is not based on inhibition of DNA methyltransferase
    ♦ Before patient registration/randomization, written informed consent must be given according to ICH/GCP and national/local regulations
    ♦ età ≥ 60 anni
    ♦ WHO performance status: ≤ 2
    ♦Eleggibilità per una chemioterapia intensiva standard
    ♦ I pazienti potenzialmente fertili devono utilizzare misure di controllo delle nascite adeguate, come definito dallo sperimentatore, durante il periodo di trattamento dello studio e per almeno 3 mesi dopo l'ultimo trattamento in studio. Un metodo altamente efficace di controllo delle nascite è definito come quelli che provocano basso tasso di fallimento (cioè meno di 1% all'anno) se utilizzato in modo coerente e corretto
    ♦ Avere nuova diagnosi di leucemia mieloide acuta che sia citopatologicamente confermata secondo la classificazione WHO i (pazienti possono essere diagnosticati con AML due mesi prima della randomizzazione)
    ♦ è consentita la leucemia mieloide acuta secondaria o de novo;
    WBC è ≤30x109 / L (misurata nelle 72 ore precedenti la randomizzazione)
    ♦ Le seguenti valutazioni di laboratorio devono essere effettuate entro 7 giorni prima della randomizzazione e dovrebbero essere compresi nel seguente intervallo:
    ♦ SGOT (AST) e SGPT (ALT) <2,5 x il limite superiore del range normale (presso il laboratorio in cui sono state eseguite le analisi) a meno che ritenuto AML-correlato
    ♦ totale livello di bilirubina sierica <2,5 x il limite superiore del range normale (presso il laboratorio in cui sono state eseguite le analisi) a meno che ritenuto AML-correlato oa causa di sindrome di Gilbert
    ♦ La concentrazione sierica di creatinina <2,5 x il limite superiore del range normale (presso il laboratorio in cui sono state eseguite le analisi) a meno che ritenuto AML-correlato
    ♦ I seguenti trattamenti per precedente MDS o MPN sono permessi a patto che il trattamento sia fermato un mese prima dell'inclusione:
    Fattoridi crescita, trombomimetici, immunosoppressione (ciclosporina A, steroidi, antitimocita globulina ecc), chelanti, interferoni, anagrelide
    -Lenalidomide, Chemioterapia a basso dosaggio (basso dosaggio melfalan, idrossiurea, basse dosi di citarabina, ecc), inibitori della tirosin-chinasi, inibitori della deacetilasi istoniche (ad esempio acido valproico, panobinostat ecc), inibitori di mTOR, altro trattamento sperimentale che non è basata sulla inibizione della DNA metiltransferasi
    ♦ Prima della registrazione / randomizzazione del paziente, deve essere fornito il consenso informato scritto secondo ICH / GCP e le normative locali / nazionali.
    E.4Principal exclusion criteria
    ♦ Presence of acute promyelocytic leukaemia (APL, i.e. AML-M3 with t(15;17)(q22;q12); PML-RARA fusion gene and cytogenetic variants)
    ♦ Presence of blast crisis of chronic myeloid leukaemia
    ♦ Presence of active central nervous system (CNS) leukaemia
    ♦ No prior treatment for AML (relapsed AML is not allowed), these are any antileukaemic therapy including investigational agents and hypomethylating agents (decitabine, 5-azacytidine). Exception: Treatment with Hydroxyurea (HU) is allowed to control the leukocytosis if given for a maximum of 5 days and is stopped at least two days prior to the start of any of the protocol regimens
    ♦ No prior treatment for MDS or MPN with:
    -hypomethylating agents (decitabine, 5-azacytidine), OR
    -intensive chemotherapy or transplantation within the last three years
    ♦ Presence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by MUGA scan or echocardiogram.
    ♦ Presence of concomitant malignancy requiring chemotherapy or any malignancy (except basal and squamous cell carcinoma of the skin) for which the patient received chemotherapy within 6 months prior to randomization
    ♦ Presence of active uncontrolled infection
    ♦ Presence of any psychological, familial, sociological or geographical condition in the opinion of the investigator potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    ♦ Presenza di leucemia promielocitica acuta (APL, cioè AML-M3 con t (15; 17) (q22, q12); PML-RARA gene di fusione e varianti citogenetiche)
    ♦ Presenza di crisi blastica della leucemia mieloide cronica
    ♦ Presenza di leucemia attiva nel sistema nervoso centrale (CNS)
    ♦ Nessun precedente trattamento per la leucemia mieloide acuta (non è consentita AML in recidiva), si tratta di una terapia antileucemica compresi gli agenti di sperimentazione e agenti ipometilanti (decitabina, 5-azacitidina). Eccezione: Il trattamento con idrossiurea (HU) è autorizzato per controllare la leucocitosi somministrata per un massimo di 5 giorni e viene interrotta almeno due giorni prima dell'inizio di uno qualsiasi dei regimi terapeutici
    ♦ Nessun trattamento preliminare per MDS o MPN con:
    agenti - ipometilanti (decitabina, 5-azacitidina), O
    -Chemioterapia intensiva o il trapianto negli ultimi tre anni
    ♦ Presenza di gravi malattie cardiovascolari concomitanti che renderebbero impossibile la chemioterapia intensiva, ad esempio le aritmie che richiedono un trattamento cronico, insufficienza cardiaca congestizia o cardiopatia ischemica sintomatica, ridotta funzione ventricolare sinistra valutata da MUGA scan o ecocardiogramma.
    ♦ Presenza di neoplasia concomitante richiedente chemioterapia o qualsiasi tumore maligno (ad eccezione di carcinoma a cellule basali e squamose della pelle) per il quale il paziente ha ricevuto chemioterapia nei 6 mesi precedenti la randomizzazione
    ♦ Presenza di infezione non controllata attiva
    ♦ Presenza di qualsiasi condizione psicologica, familiare, sociologica o geografica che, a giudizio dello sperimentatore potenzialmente possa ostacolare il rispetto del protocollo di studio il e programma di follow-up; queste condizioni dovrebbero essere discusse con il paziente prima della registrazione nello studio
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    La sopravvivenza globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization until death
    Tempo dalla randomizzazione fino alla morte
    E.5.2Secondary end point(s)
    ♦ CR/CRi rate, response rate (CR/CRi and PR), overall CR/CRi rate, DFS, PFS
    ♦ Safety and toxicity
    ♦ Transplantation feasibility: percentage of patients transplanted
    ♦ Outcome post-transplantation: PFS, incidence of relapse or progression, and incidence of NRPM (or TRM)
    ♦ Days of staying in hospital and transfusion needs
    ♦ HRQoL (EORTC QLQ-C30, ELD14)
    ♦ The prognostic value of baseline physical and functional conditions using a comprehensive geriatric assessment tools (short
    ♦ Sicurezza e tossicità
    ♦ Fattibilità del Trapianto: percentuale di pazienti trapiantati
    ♦ Esito post-trapianto: PFS, l'incidenza di recidiva o progressione, e l'incidenza di NRPM (o TRM)
    ♦ giorni di permanenza in ospedale e necessità di trasfusioni
    ♦ HRQoL (EORTC QLQ-C30, ELD14)
    ♦ Il valore prognostico delle condizioni fisiche e funzionali di base con una completa valutazione geriatrica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression Free Survival (time from randomization till progression, relapse or death without progression)
    Sopravvivenza libera da progressione (tempo dalla randomizzazione fino alla progressione, recidiva o morte senza progressione
    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 Yes
    E.6.13.1Other scope of the trial description
    Health-related Quality of Life
    Qualità motivi di salute 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) 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 Yes
    E.8.1.7.1Other trial design description
    cross-over possible (patients progressing in decitabine arm standard arm chemotherapyis recommended)
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    The end of trial is defined as follows
    1. Thirty days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The long-term follow-up for OS (i.e. an additional 2 years of FU after the analysis of the first endpoint)
    4. The database has been fully cleaned and frozen for these 2 analyses
    La fine del processo è definito come segue
    1. trenta giorni dopo che tutti i pazienti hanno interrotto il trattamento protocollo
    2 la sperimentazione è matura per l'analisi dell'endpoint primario, come definito nel protocollo
    3.-Follow-up a lungo termine per l’OS (cioè ulteriori 2 anni di FU dopo l'analisi dell’end point primario)
    4 Il database è stato completamente pulito e congelato per questi 2 analisi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 386
    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 state347
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 253
    F.4.2.2In the whole clinical trial 600
    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)
    According to the discretion of the treating physician.
    A discrezione del medico curante.
    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 Decision2015-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-03-26
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