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    Summary
    EudraCT Number:2014-001486-27
    Sponsor's Protocol Code Number:1301-LG
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-16
    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 ConcernedSlovakia - SIDC (Slovak)
    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
    Štúdia s 10-dňovým decitabínom v porovnaní s konvenčnou chemoterapiou (režim 3+7) s následnou alogénnou transplantáciou u pacientov s AML ≥ 60 rokov: III fáza randomizovanej štúdie pracovnej skupiny EORTC pre liečbu leukémie, CELG, GIMEMA a nemeckej študijnej skupiny MDS.
    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
    Štúdia s 10-dňovým decitabínom v porovnaní s konvenčnou chemoterapiou (režim 3+7) s následnou alogénnou transplantáciou u pacientov s AML ≥ 60 rokov: III fáza randomizovanej štúdie pracovnej skupiny EORTC pre liečbu leukémie, CELG, GIMEMA a nemeckej študijnej skupiny MDS.
    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).
    Akútna myeloidná leukémia (AML), v staršej populácii (rovná alebo starší ako 60 rokov).
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukaemia (AML) in elderly population (equal or older than 60 years).
    Akútna myeloidná leukémia (AML), v staršej populácii (rovná alebo starší ako 60 rokov).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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.
    Primárnym cieľom tejto randomizovanej štúdie vo fáze III je vyhodnotiť, , účinok 10-dňovej liečby decitabínom v dávke 20 mg/m2 v porovnaní s konvenčnou indukčnou chemoterapiou (režim 3+7) na celkové prežívanie (OS, z angl. overall survival) u starších pacientov s akútnou myeloidnou leukémiou (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
    Sekundárne ciele
    • Porovnať iné ukazovatele účinnosti medzi dvoma liečebnými ramenami: t. j. dosahovanie kompletnej odpovede (CR/CRi), mieru odpovede (CR, CRi a PR), a prežívanie bez progresie (PFS, progression-free survival).
    • Určiť v každom liečebnom ramene prežívanie bez choroby (DFS, disease-free survival) pri dosiahnutí CR, výskyt relapsu a úmrtnosti nespôsobenej relapsom (NRM, non-relapse mortality) pri dosiahnutí CR.
    • Porovnať bezpečnostný profil a profil toxicity medzi dvoma liečebnými ramenami.
    • Určiť realizovateľnosť alloHCT s prípravným režimom v redukovanej intenzite v každom liečebnom ramene.
    • Určiť výsledok transplantácie v každom liečebnom ramene: PFS po alloHCT, výskyt relapsu alebo progresie a úmrtnosti nespôsobenej relapsom/progresiou (NRPM, non-relapse/progression mortality) alebo úmrtnosti v súvislosti s liečbou (TRM, treatment related mortality) po alloHCT.
    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
    • Vek ≥60 rokov,
    • Stav telesnej zdatnosti podľa Svetovej zdravotníckej organizácie (WHO): ≤ 2 (Appendix C).
    • Spôsobilosť na štandardnú intenzívnu chemoterapiu.
    • Novo diagnostikovaná AML, ktorá je cytopatologicky potvrdená podľa klasifikácie WHO (Appendix K) (pacientom môže byť diagnostikovaná AML dva mesiace pred randomizáciou).
    • Absencia akútnej promyelocytickej leukémie (APL), t. j. AML-M3 s t(15;17)(q22;q12); PML-RARA fúzny gén a cytogenetické varianty).
    • De novo alebo sekundárna AML je povolená [Dôležité: sekundárna AML zahŕňa AML, ktorá vznikla po vystavení cyto-/genotoxickej liečbe alebo po výskyte malígneho či nemalígneho ochorenia].
    • Absencia blastovej krízy chronickej myeloidnej leukémie.
    • Absencia aktívnej leukémie centrálneho nervového systému (CNS).
    • Počet bielych krviniek (WBC) je ≤30 x 109/l (merané v rámci 72 hodín pred randomizáciou). [Dôležité: liečba hydroxymočovinou (HU) je povolená, aby sa dosiahlo toto kritérium spôsobilosti].
    • Nasledujúce laboratórne vyšetrenia sa majú spraviť do 7 dní pred randomizáciou a majú byť v nasledujúcom rozsahu:
    • AST (SGOT) a ALT (SGPT) < 2,5 x horný limit normálneho rozsahu (v laboratóriu, kde boli analýzy vykonané), pokiaľ sa hodnoty nepovažujú za súvisiace s AML.
    • Celková hladina bilirubínu v sére < 2,5 x horný limit normálneho rozsahu (v laboratóriu, kde boli analýzy vykonané), pokiaľ sa patologická hodnota nepovažuje za súvisiacu s AML alebo bola spôsobená Gilbertovým syndrómom.
    • Sérová koncentrácia kreatinínu < 2,5 x horný limit normálneho rozsahu (v laboratóriu, kde boli analýzy vykonané), pokiaľ sa hodnotanepovažuje za súvisiacu s AML.
    • Pacienti nedostali žiadnu predošlú liečbu AML (relapsujúca AML nie je povolená), napr. liečbu leukémie zahŕňajúcu skúmané lieky a hypometylačné lieky (decitabín, 5-azacytidín). Liečba HU je povolená na kontrolu leukocytózy, ak sa podáva najviac 5 dní.
    • Pacienti nedostali predošlú liečbu na myelodysplastický syndróm (MDS) či myeloproliferatívne neoplázie (MPN) použitím:
    • hypometylačných liekov (decitabín, 5-azacytidín) ALEBO
    • intenzívnej chemoterapie či transplantácie za posledné tri roky.
    • POZNÁMKA: Pokiaľ liečba bola ukončená najmenej jeden mesiac pred zaradením, sú povolené tieto lieky na predchádzajúce MDS alebo MPN:
    • rastové faktory, trombomimetiká, imunosupresíva (cyklosporín A, steroidy, antitymocytový globulín atď.), chelačné lieky, interferóny, anagrelid,
    • lenalidomid, nízkodávková chemoterapia (nízkodávkový melfalán, HU, nízkodávkový cytarabín atď.), inhibítory tyrozín-kinázy, inhibítory histonových deacetyláz (napr. kyselina valproová, panobinostat atď.), inhibítory mTOR, iná experimentálna liečba, ktorá nie je založená na inhibícii metyltransferázy kyseliny deoxyribonukleovej (DNA).
    • Absencia súbežného závažného kardiovaskulárneho ochorenia, ktoré by spôsobilo nemožnosť intenzívnej chemoterapie, t. j. arytmie vyžadujúcej chronickú liečbu, kongestívneho zlyhávania srdca alebo symptomatickej ischemickej choroby srdca, zníženej funkcie ľavej srdcovej komory podľa hodnotenia skenu rádionuklidovej ventrikulografie (MUGA) alebo echokardiogramu.
    • Absencia súbežnej malignity alebo akejkoľvek malignity vyžadujúcej chemoterapiu (okrem bazocelulárneho a skvamocelulárneho karcinómu kože), na ktoré pacient dostával chemoterapiu v posledných 6 mesiacoch pred randomizáciou.
    POZNÁMKA: Diagnóza predošlej alebo súbežnej malignity tak nie je vylučovacím kritériom.
    • Absencia aktívnej nekontrolovanej infekcie.
    • Pacienti v reprodukčnom veku majú používať vhodné antikoncepčné opatrenia určené skúšajúcim lekárom počas trvania liečby štúdie a najmenej 3 mesiace po poslednej liečbe v rámci štúdie. Vysokoúčinná metóda kontroly počatia je definovaná ako metóda, ktorá má nízku mieru zlyhania (t. j. menej než 1 % ročne), ak sa používa správne a sústavne.
    • Absencia každého psychického, rodinného, sociologického alebo geografického stavu, ktorý podľa názoru skúšajúceho lekára potenciálne narúša dodržiavanie protokolu štúdie a plánu ďalšieho sledovania; tieto záležitosti majú byť prediskutované s pacientom pred randomizáciou skúšania.
    • Pacienti pred registráciou/randomizáciou musia dať písomný informovaný súhlas podľa osvedčených postupov Medzinárodnej konferencie o harmonizácii (ICH GCP) a vnútroštátnych alebo miestnych predpisov.
    Dôležitá POZNÁMKA: Všetky vstupné kritériá musia byť splnené.

    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
    prítomnosť akútnej promyelocytovou leukémie (APL, tj AML-M3 s t (15; 17) (q22; q12); PML-RARA fúznym génom a cytogenetickej varianty)
    ♦ Prítomnosť v blastickej kríze chronickej myeloidnej leukémie
    ♦ Prítomnosť aktívneho centrálneho nervového systému (CNS), leukémia
    ♦ Žiadne predchádzajúca liečba AML (AML relapsujúcou nie je povolené), sa jedná o akúkoľvek antileukemik terapiu vrátane klinické hodnotenie agentov a agentov hypomethylating (decitabinem, 5-azacytidinu). Výnimka: Liečba hydroxymočovine (HU) je povolené riadiť leukocytóza, ak daný dobu maximálne 5 dní a zastaví sa aspoň dva dni pred začiatkom ktoréhokoľvek z režimov protokolu
    ♦ bez predchádzajúceho liečbu MDS alebo MPN sa:
    -hypomethylating látky (decitabinem, 5-azacytidinu), alebo
    -intensive chemoterapii alebo transplantácii v posledných troch rokoch
    ♦ Existencia súčasného závažným kardiovaskulárnym ochorením, ktorý by intenzívna chemoterapia nemožné, teda arytmie vyžadujúce chronickú liečbu, kongestívne srdcové zlyhanie alebo symptomatická ischemická choroba srdca, zníženou funkciou ľavej komory posúdia MUGA alebo echokardiografické vyšetrenie.
    ♦ Existencia súčasného malignít vyžadujúce chemoterapie alebo iné malignity (okrem bazálnej a spinocelulárneho karcinómu kože), pre ktorý bol pacient chemoterapiu, do 6 mesiacov pred randomizáciou
    ♦ Prítomnosť aktívneho nekontrolované infekcie
    ♦ Prítomnosť akejkoľvek psychologickej, rodinnej, sociologické alebo geografické podmienky, podľa názoru vyšetrovateľa potenciálne ohrozuje dodržiavanie protokolu štúdie a následné-up plánu; tieto podmienky by mali byť prerokované s pacientom pred registráciou v procese
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    celkové prežívanie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization until death
    Čas od randomizácie do úmrtia
    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

    CR / CRI rate, miera odpovede (CR / CRI a PR), celkovo CR / CRI rýchlosť, DFS, PFS
    ♦ Bezpečnosť a toxicita
    ♦ Transplantácia uskutočniteľnosti: percento pacientov transplantovaných
    ♦ Výsledok po transplantácii: PFS, incidencia relapsu alebo progresie a výskyt NRPM (alebo TRM)
    ♦ Dni ​​pobytu v nemocnici a transfúznych potreby
    ♦ HRQoL (EORTC QLQ-C30, ELD14)
    ♦ Predpokladaný význam základných fyzikálnych a funkčných podmienok použitia komplexného geriatrického hodnotiace nástroje (krátky












    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression Free Survival (time from randomization till progression, relapse or death without progression)
    Prežívanie bez
    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
    Súvisiace so zdravím kvalita života









    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Koniec procesu je definovaný nasledovne
    1. tridsať dní po všetkých pacientov ukončení liečby protokolu
    2. Skúšobné je zrelý pre analýzu primárneho cieľa, ako je definované v protokole
    3. Dlhodobá sledovanie pre OS (tj ďalšie 2 roky FU po analýze prvého koncového bodu)
    4. Databáza bola úplne vyčistená a mrazené pre tieto dve analýzy
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 554
    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.
    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 Decision2014-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
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