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    Summary
    EudraCT Number:2014-003150-13
    Sponsor's Protocol Code Number:TUD-DELTA1-063
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-01-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003150-13
    A.3Full title of the trial
    A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in AML patients ≥65 years of age not eligible for intensive chemotherapy
    Randomisierte Placebo-kontrollierte Phase-II-Studie zu Decitabin in Kombination mit oder ohne Eltrombopag bei AML-Patienten ≥65 Jahre, für die eine intensive Chemotherapie nicht in Frage kommt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in patients with acute myeloid leukemia ≥65 years of age not eligible for intensive chemotherapy
    Randomisierte Placebo-kontrollierte Phase-II-Studie zu Decitabin in Kombination mit oder ohne Eltrombopag bei Patienten mit akuter myeloischer Leukämie ≥65 Jahre, für die eine intensive Chemotherapie nicht in Frage kommt
    A.3.2Name or abbreviated title of the trial where available
    DELTA
    A.4.1Sponsor's protocol code numberTUD-DELTA1-063
    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 SponsorTechnische Universität Dresden
    B.1.3.4CountryGermany
    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 supportGlaxoSmithKline GmbH & Co KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Dresden, Med. Klinik und Poliklinik I
    B.5.2Functional name of contact pointcoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstraße 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number04903514582583
    B.5.5Fax number04903514584367
    B.5.6E-mailuwe.platzbecker@uniklinikum-dresden.de
    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 Revolade
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Trading Services Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEltrombopag
    D.3.2Product code SB-497115
    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 INNELTROMBOPAG
    D.3.9.1CAS number 496775-61-2
    D.3.9.2Current sponsor codeSB-497115 (Eltrombopag)
    D.3.9.4EV Substance CodeSUB30140
    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 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 nameEltrombopag
    D.3.2Product code SB-497115
    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 INNELTROMBOPAG
    D.3.9.1CAS number 496775-61-2
    D.3.9.2Current sponsor codeSB-497115 (Eltrombopag)
    D.3.9.4EV Substance CodeSUB30140
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute myeloid leukemia
    AML
    Akute myeloische Leukämie
    AML
    E.1.1.1Medical condition in easily understood language
    acute myeloid leukemia
    AML
    Akute myeloische Leukämie
    AML
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To study whether supportive treatment with eltrombopag improves treatment change-free survival (TCFS) in AML patients ≥65 years of age when added to standard treatment with DAC
    Einfluss einer zusätzlichen palliativen Behandlung mit Eltrombopag zur Standardtherapie mit Decitabin auf das behandlungsänderungsfreie Überleben von AML Patienten ≥ 65 Jahre
    E.2.2Secondary objectives of the trial
    • overall survival (OS)
    • relapse free survival (RFS)
    • overall response rate (CR, PR, SD)
    • number of bone marrow blasts after 5, 9 and 12 months
    • quality of life (QLQ-C30 and SF-36)
    • bleeding events
    • median platelet counts
    • number of platelet transfusions
    • hospitalization rate
    • safety and tolerability of treatment with EPAG / placebo
    • impact of comorbidities on predicting overall survival
    • Gesamtüberleben (OS)
    • Rezidiv-freies Überleben (RFS)
    • Gesamtansprechrate (CR, PR, SD)
    • Blastengehalt im Knochenmark nach 5, 9 und 12 Monaten
    • Lebensqualitätsfragebögen (QLQ-C30 and SF-36)
    • Inzidenz von Blutungen
    • mediane Thrombozytenzahl
    • Anzahl an Thrombozytentransfusionen
    • Hospitalisierungsrate
    • Sicherheit und Verträglichkeit der EPAG / Placebo-Behandlung
    • Einfluss von Komorbiditäten auf die Vorhersage des Gesamtüberlebens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Newly diagnosed AML (including therapy-related or after antecedent MDS) other than APL according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be <20%
    • Age ≥ 65 years
    • ECOG performance status 0-3
    • Patients not eligible for intensive induction therapy
    • Planned therapy with DAC
    • Platelet count <75 Gpt/L taken within 4 weeks prior to randomization
    • Signed Informed Consent
    • Adequate liver function as assessed by the following laboratory requirements:
    o Total bilirubin ≤ 3 times the upper limit of normal (except for Gilbert’s Syndrome)
    o ALT and AST ≤ 3 times upper limit of normal
    • neu diagnostizierte AML (einschließlich Therapie-assoziiert oder nach vorangegangenem MDS) außer APL nach WHO Kriterien; d. h. Knochenmarkaspirat- oder biopsie muss ≥20% Blasten unter allen kernhaltigen Zellen aufweisen oder im Differentialblutbild müssen ≥20% Blasten nachgewiesen werden. Bei einer durch zytrogenetische Aberationen definierte AML können die Blasten auch <20% betragen.
    • Alter ≥ 65 Jahre
    • ECOG performance status 0-3
    • nicht geeignet für intensive Induktionstherapie
    • geplante Therapie mit DAC
    • Thrombozytenzahl <75 Gpt/L (Befund innerhalb 4 Wochen vor Randomisierung)
    • unterzeichnete Einwilligungserklärung nach Aufklärung
    • adäquate Leberfunktion; folgende Voraussetzungen sind einzuhalten:
    o Gesamt-Bilirubin ≤ 3-faches des oberen Normalwertes (außer Gilbert’s Syndrome)
    o ALT und AST ≤ 3-faches des oberen Normalwertes
    E.4Principal exclusion criteria
    • Acute promyelocytic leukemia (APL)
    • History of MDS or AML treatment with TPO-R agonists (Revolade, NPlate or other TPO-R agonists), hypomethylating agents or intensive chemotherapy
    • NYHA stage ≥ 2 due to heart insufficiency
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
    • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
    • Active and uncontrolled infections
    • positive Human Immunodeficiency Virus (HIV) or positive Hepatitis B or C serology
    • Patients unable to swallow medication
    • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or DAC or excipients that contraindicate their participation.
    • Akute Promyelozytenleukämie (APL)
    • Bekanntes Hochrisiko-MDS oder vorherige Behandlung der AML mit einem TPO-R-Agonisten (z. B. Revolade, NPlate oder andere TPO-R-Agonisten), hypomethylierende Medikamente oder intensive Chemotherapie
    • NYHA-Stadium ≥ 2 (aufgrund von Herzinsuffizienz)
    • aktueller Drogen- oder Alkoholabusus
    • Behandlung mit einem Prüfmedikament innerhalb von 30 Tagen bzw. 5 Halbwertszeiten (je nach dem welches länger dauert) vor Erhalt der ersten Studienmedikation
    • aktive unkontrollierte Infektion
    • Patienten, die nicht in der Lage sind Tabletten zu schlucken
    • positive HIV- oder Hepatitis-Serologie (Hepatitis B und C)
    • bekannte Überempfindlichkeit gegenüber der Prüfmedikation oder stukturverwandte Substanzen
    E.5 End points
    E.5.1Primary end point(s)
    Treatment change-free survival (TCFS)
    Behandlungsänderungs-freies Überleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    date of treatment change or death
    Datum der Änderung der Behandlung oder Tod
    E.5.2Secondary end point(s)
    • Overall Survival (OS) in presence of competing risk treatment change
    • Overall response rate (CR, PR, SD)
    • Relapse free survival (RFS)
    • Median platelet counts
    • Number of platelet transfusions during cycles 1-4
    • Incidence of bleeding events
    • Number of bone marrow blasts from baseline and after 5, 9 and 12 months
    • Hospitalization rate (days in hospital)
    • Safety and tolerability of treatment with EPAG / placebo
    • Quality of life
    • impact of comorbidities on predicting overall survival
    • Gesamtüberleben (OS)
    • Gesamtansprechrate (CR, PR, SD)
    • Rezidiv-freies Überleben (RFS)
    • Mediane Thrombozytenzahl
    • Anzahl Thrombozytentransfusionen während der Zyklen 1-4
    • Inzidenz von Blutungen
    • Anzahl an Knochenmarkblasten zur Baseline; sowie nach 5, 9 und 12 Monaten
    • Rate an Hospitalisierungen (Krankenhaustage)
    • Sicherheit und Verträglichkeit der Behandlung mit EPAG / Placebo
    • „Quality of life“
    • Einfluss von Komorbiditäten auf die Vorhersage des Gesamtüberlebens
    E.5.2.1Timepoint(s) of evaluation of this end point
    • whole study
    • date of relapse, death
    • cycles 1-4, 5, 9 and 12
    • follow up after treatment discontinuation: week 2, month 3, 6, 9, 12, 24, 36, and 48
    • während der gesamten Studiendauer
    • Datum des Rezidives, Todes
    • Zyklus 1-4, 5, 9 und 12
    • Follow Up nach Abbruch/Ende der Behandlung: Woche 2, Monat 3, 6, 9, 12, 24, 36, 48
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned30
    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 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
    Letzte Visite des letzten Patienten
    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: 238
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state238
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 238
    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)
    After discontinuation of study treatment, patients will pass the end of study visit and survival will further be observed during follow up for a maximum of 4 years after randomization. Following discontinuation of EPAG, thrombocytopenia is likely to reoccur. Therefore, platelet counts should be monitored weekly for 4 weeks. Upon discontinuation from assigned study treatment, subjects may receive additional (non protocol) therapy at the discretion of the treating physician.
    Nach Beendigung der Studienbehandlung erfolgt eine Abschlussvisite. Im Rahmen eines Follow Ups wird das Überleben der Patienten bis maximal 4 Jahre nach Randomisierung weiter beobachtet. Nach Absetzen von EPAG kann eine Thrombozytopenie erneut auftreten. Daher sollte die Anzahl der Thrombozyten im ersten Monat wöchentlich überwacht werden. Die Folgetherapie und weitere Behandlung ist nicht Gegenstand der Studie und liegt im Ermessen des behandelnden Arztes.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SAL - Study Alliance Leukemia
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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