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    Summary
    EudraCT Number:2020-000508-13
    Sponsor's Protocol Code Number:72779
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-04-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-000508-13
    A.3Full title of the trial
    An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia
    Een open-label, gerandomiseerde, klinische studie naar het gebruik van teicoplanine als infectieprofylaxe bij kinderen met acute myeloide leukemie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of the use of teicoplanin in children with blood cancer to prevent infections
    Een klinische studie naar het gebruik van teicoplanine bij kinderen met bloedkanker om infecties te voorkomen
    A.3.2Name or abbreviated title of the trial where available
    Pro-Teico study
    Pro-Teico studie
    A.4.1Sponsor's protocol code number72779
    A.5.4Other Identifiers
    Name:Dutch Trial RegisterNumber:NL8130
    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 SponsorPrincess Máxima Center for Pediatric Oncology
    B.1.3.4CountryNetherlands
    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 supportPrincess Máxima Center for Pediatric Oncology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Ghent
    B.5.2Functional name of contact pointHIRUZ
    B.5.3 Address:
    B.5.3.1Street AddressCorneel Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number00309332 09 39
    B.5.6E-mailhiruz.ctu@uzgent.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 Targocid
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    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.3.4Pharmaceutical form Powder and solvent 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 INNTeicoplanin
    D.3.9.1CAS number 61036-64-4
    D.3.9.4EV Substance CodeSUB04714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number66.67
    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 leukemia
    Acute myeloide leukemie
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Bloedkanker
    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 LLT
    E.1.2Classification code 10024346
    E.1.2Term Leukemia myeloblastic acute
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety run-in:
    To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety if they experience a DLT during a prophylactic cycle with teicoplanin or, in case no DLT occurs, if exposure to teicoplanin is either at least 2 consecutive weeks with at least 5 doses of teicoplanin or at least 3 weeks in total with at least 6 out of 9 doses of teicoplanin, or 8 out of 12 doses in case of 4 weeks, or 10 out of 15 doses in case of 5 weeks.

    Randomized phase:
    To evaluate whether i.v. teicoplanin prophylaxis in children with newly-diagnosed AML decreases the occurrence of culture-proven BSIs with VGS during treatment.
    Safety run-in:
    De veiligheid beoordelen van i.v. teicoplanine profylaxe, toegediend op 3 dagen per week met een doseringsinterval van twee tot drie dagen bij kinderen met nieuw gediagnosticeerde AML. Een patiënt is evalueerbaar voor het beoordelen van de veiligheid als er een dosisbeperkende toxiciteit optreedt tijdens een profylactische cyclus met teicoplanine. Of, als er geen dosisbeperkende toxiciteit is opgetreden, de patiënt ten minste 5 doseringen teicoplanine heeft gekregen in 2 opeenvolgende weken of als de patiënt ten minste tijdens 3 weken tijd in totaal 6 van de 9 doseringen teicoplanine heeft gekregen, of 8 van de 12 doseringen of 10 van de 15 doseringen.

    Randomized controlled trial:
    Evalueren of de toediening van i.v. teicoplanine profylaxe tijdens de behandeling van kinderen met nieuw gediagnosticeerde AML
    het aantal, met een bloedkweek bewezen, VGS-infecties kan verminderen.
    E.2.2Secondary objectives of the trial
    Safety run-in:
    To (preliminary) characterize the PK parameters of teicoplanin in children with newly-diagnosed AML.

    Randomized controlled trial:
    Evaluate whether i.v. teicoplanin prophylaxis decreases the occurrence of any culture-proven bacterial BSI; assess the impact of teicoplanin prophylaxis on the number of intensive care admissions; the frequency of infectious-related morbidity and mortality; evaluate whether i.v. teicoplanin prophylaxis affects neutrophil recovery time; development of teicoplanin-related bacterial resistance; The safety and AEs; To study if there is a confounding effect of the use of other antibiotics (e.g., fluoroquinolones) on the occurrence of culture-proven (VGS) bacterial BSIs; To assess PK parameters and construct a population PK model; To study the potential effect of co-variables on teicoplanin clearance; associations between serum levels of teicoplanin and the occurrence of culture-proven (VGS) bacterial BSIs. To describe the CIR, EFS and OS.
    Safety run-in: Het karakteriseren van PK-parameters van teicoplanine bij kinderen met nieuw gediagnosticeerde AML.
    Randomized controlled trial:
    Evalueren of i.v. teicoplanine-profylaxe het aantal, met bloedkweek bewezen, infecties kan verminderen; impact van teicoplanine-profylaxe op het aantal intensive care-opnames bepalen; frequentie van infectieuze morbiditeit en mortaliteit; invloed teicoplanine-profylaxe op hersteltijd van aantal neutrofielen; ontwikkeling van teicoplanine-gerelateerde bacteriële resistentie; veiligheid en AE's; onderzoeken of er 'n effect is van gebruik andere antibiotica (bijv. fluorochinolonen) op 't vóórkomen van, met bloedkweek bewezen, (VGS)-infecties; beoordelen PK parameters en een populatie PK model construeren; Om het potentiële effect van co-variabelen op de klaring van teicoplanine te bestuderen; associaties tussen serumspiegels van teicoplanine en het vóórkomen van, met een bloedkweek bewezen, (VGS)-infectie. CIR, EFS en OS beschrijven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Newly diagnosed with AML
    Being registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a consecutive protocol
    Age 0-19 years
    Written informed consent by the patient and/or legal guardians (whatever applicable according to the patients age)
    Nieuw gediagnosticeerd met AML
    Geregistreerd voor en gestart met de behandeling volgens het NOPHO-DBH AML 2012 studieprotocol, of een opvolgend protocol
    Leeftijd 0-19 jaar
    Schriftelijke geïnformeerde toestemming van de patiënt en / of wettelijke voogden (afhankelijk van de leeftijd van de patiënt)
    E.4Principal exclusion criteria
    Acute promyelocytic leukemia
    Secondary AML
    Down Syndrome
    Preexisting primary immunodeficiency
    Patients who receive regular antibiotic prophylaxis against Gram-positive bacteria for other conditions than leukemia-related
    Patients with a history of an anaphylactic reaction (CTCAE grade ≥3) to teicoplanin and/or vancomycin
    Patients with an eGFR of <30 ml/min/1.73m2 at the start of the study
    Patients with a history of severe impaired hearing (CTCAE grade ≥3)
    Pregnant or breast-feeding patients
    Patients that are participating in another clinical study with an IMP, that interferes with the study objectives
    Acute promyelocyten leukemie
    Secundaire AML
    Syndroom van Down
    Bestaande primaire immuundeficiëntie
    Patiënten die regelmatig antibiotica-profylaxe tegen grampositieve bacteriën krijgen voor andere aandoeningen dan leukemie-gerelateerd
    Patiënten met een voorgeschiedenis van een anafylactische reactie (CTCAE graad ≥3) op teicoplanine en/of vancomycine
    Patiënten met een eGFR van <30 ml/min/1,73 m2 aan het begin van het onderzoek
    Patiënten met een voorgeschiedenis van ernstig gehoorverlies (CTCAE graad ≥3)
    Zwangere of borstvoeding gevende patiënten
    patiënten die deelnemen aan een andere klinische studie met een onderzoeksgeneesmiddel, die interfereert met de studiedoelstellingen
    E.5 End points
    E.5.1Primary end point(s)
    Safety run-in:
    The number of DLTs observed

    Randomized controlled trial:
    The (first) occurrence of culture-proven BSIs with VGS during initial AML treatment;
    Date(s) of BSI(s) with VGS
    Safety run-in:
    Het aantal waargenomen DLT's

    Randomized controlled trial:
    1. De (eerste) met een bloedkweek bewezen VGS-infectie tijdens de initiële AML-behandeling;
    2. Datum van de met een bloedkweek bewezen VGS infectie
    E.5.1.1Timepoint(s) of evaluation of this end point
    During and after the safety run-in
    During the randomized controlled trial
    Gedurende en na de safety run-in
    Gedurende de randomized controlled trial
    E.5.2Secondary end point(s)
    Safety run-in:
    -Css,max
    -Css,min
    -Tss,max
    -Area under the curve
    -Clearance (inter-compartmental, total, renal fraction)
    -Volume of distribution (central and peripheral)

    Randomized controlled trial:
    1. The number of BSIs with culture-proven bacteria
    2. Results of all positive blood cultures
    3. Infection-related (pediatric) intensive care admissions;
    4. The number of episodes/admissions with (neutropenic) fever; days with fever (with or without neutropenia), days with FN, Days with neurtopenia
    5. Infection-free survival time, i.e., time from diagnosis till first culture-proven BSI;
    6. Infection-related mortality;
    7. Number of days until neutrophil recovery (ANC of ≥0.5 x109/L following the nadir);
    8. Resistance patterns of pathogenic isolates from blood cultures;
    9. Incidence of resistant bacteria in throat and rectal cultures, e.g.,; VRE
    10. AEs of special interest;
    11. Serious adverse events (SAEs);
    12. Use of (other) antibiotics, antifungals and antivirals;
    13. Serum creatinine levels
    14. Serum teicoplanine levels
    15. Cumulative incidence of relapse
    16. Event-free survival
    17. Overall survival
    Safety run-in:
    -Css,max; Css,min, Tss,max; "Area under the curve", Klaring (inter-compartimentaal, totaal, renale fractie), Verdelingsvolume (centraal en perifeer)

    Randomized controlled trial:
    1. Het aantal met een bloedkweek bewezen infecties veroorzaakt door elke mogelijke bacterie
    2. Resultaten van alle positieve bloedkweken
    3. Infectie-gerelateerde (pediatrische) intensive care opnames
    4. Het aantal episodes/opnames met (neutropene) koorts; dagen met koorts (met of zonder neutropenie), dagen met febriele neutropenie, dagen met neutropenie
    5. Infectie-vrije overlevingstijd d.w.z. tijd van diagnose tot aan de eerste, met een bloedkweek bewezen, infectie
    6. Infectie-gerelateerde mortaliteit
    7. Het aantal dagen totdat de hoeveelheid neutrofielen hersteld is (ANC of ≥0.5 x109/L volgend op de nadir)
    7. Resistentiepatonen van pathogene isolaten uit bloedkweken
    8. Incidentie van resistente bacterien in keel en rectum kweken, bijvoorbeeld Vancomycine-Resistente Enterokokken
    9. Adverse events/Bijwerkingen met speciale interesse
    10. Serious adverse events/ernstige bijwerkingen
    11. Gebruik van (andere) antibiotica, antischimmel- en antivirale middelen
    12. Serum creatinine levels
    13. Serum teicoplanine levels
    14. Cumulatieve incidentie van recidief
    15. Event-free survival
    16. Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    During and after the safety run-in
    During the randomized controlled trial
    Gedurende en na de safety run-in
    Gedurende de randomized controlled trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standaard zorg, maar geen teicoplanine profylaxe
    Standard of care, but no teicoplanin prophylaxis
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 130
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 83
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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
    Geen
    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 Decision2022-05-16
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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