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    Summary
    EudraCT Number:2014-004817-98
    Sponsor's Protocol Code Number:Tri-VSTs
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-29
    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 ConcernedGreece - EOF
    A.2EudraCT number2014-004817-98
    A.3Full title of the trial
    Administration of Rapidly Generated Multivirus-Specific Cytotoxic TLymphocytes for the Treatment of CMV, EBV, and BK virus Infections post Allogeneic Stem Cell Transplant
    Χορήγηση ταχέως παραγόμενων, αντι-ιικών Τ-λεμφοκυττάρων πολλαπλής ειδικότητας για τη θεραπεία ιογενών λοιμώξεων από CMV, EBV και BK μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T lymphocytes to simultaneously kill 3 viruses (CMV, EBV, BK) after allogeneic stem cell transplantation
    Χορήγηση ταχέως παραγόμενων, αντι-ιικών Τ-λεμφοκυττάρων πολλαπλής ειδικότητας για τη θεραπεία ιογενών λοιμώξεων από CMV, EBV και BK μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    A.3.2Name or abbreviated title of the trial where available
    Tri-VSTs-001
    A.4.1Sponsor's protocol code numberTri-VSTs
    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 SponsorΕλληνική Αιματολογική Εταιρεία
    B.1.3.4CountryGreece
    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 supportΕλληνική Αιματολογική Εταιρεία
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationΑιματολογική Κλινική, Μονάδα Μεταμόσχευσης Αιμοποιητικών Κυττάρων, Νοσοκομείο Γ. Παπανικολάου, Θεσσαλονίκη
    B.5.2Functional name of contact pointΓιαννάκη Ευαγγελία
    B.5.3 Address:
    B.5.3.1Street AddressΕξοχή
    B.5.3.2Town/ cityΘεσσαλονίκη
    B.5.3.3Post code57010
    B.5.3.4CountryGreece
    B.5.4Telephone number+302313307518
    B.5.5Fax number+302313307521
    B.5.6E-maileyannaki@u.washington.edu
    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 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 nameΑντι-ιικά Τ-λεμφοκύτταρα τριπλής ειδικότητας
    D.3.2Product code Τri-VSTs-001
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Infections from EBV, CMV and BK virus post allogeneic Stem Cell Transplant
    Λοιμώξεις από τους ιούς EBV, CMV και BK μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    E.1.1.1Medical condition in easily understood language
    Infections from EBV, CMV and BK virus after allogeneic Stem Cell Transplant
    Λοιμώξεις από τους ιούς EBV, CMV και BK μετά από αλλογενή μεταμόσχευση αιμοποιητικών κυττάρων
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of administering virus-specific T cells (VSTs) as treatment for viral infections at Greece and the feasibility of the approach in Greece
    H δυνατότητα εφαρμογής στην Ελλάδα της κυτταρικής θεραπείας με virus-specific T cells (VSTs) κατά ιικών λοιμώξεων, η ασφάλεια και η αποτελεσματικότητα χορήγησής τους
    E.2.2Secondary objectives of the trial
    To determine i) the frequency of reactivations by the targeted virus for which the VSTs were infused, ii) the frequency of reactivations by the rest of targeted viruses post VST infusion and iii) the probability of disease relapse throughout the follow up period
    i) η συχνότητα επανεμφάνισης νέας αναζωπύρωσης από τους ιούς για τους οποίους χορηγήθηκαν τα tri-VSTs, ii) η συχνότητα αναζωπύρωσης άλλων ιών για τους οποίους τα κύτταρα ήταν επίσης ειδικά και iii) η πιθανότητα υποτροπής της νόσου κατά τη διάρκεια της παρακολούθησης του ασθενούς.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior myeoloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells from unrelated or haploidentical donors
    2. Treatment of one or multiple infections/reactivations of at least one of the targeted viruses: CMV, EBV, BK virus
    3. Karnofsky/Lansky score of ≥ 50
    4. ANC > 500/μl
    5. Bilirubin ≤ 2x*, AST < 3x*, Serum creatinine ≤ 2x* (8=maximum normal limit), HgB >8.0 g/dl
    6. Pulse oximetry of > 90% on room air
    7.Available virus-specific T cells
    8. Negative pregnancy test in female patients if applicable
    9.Written informed consent and/or signed assent line from patient, or guardian
    • Υποβολή σε μυελοαφανιστική ή μη-μυελοαφανιστική αλλογενή μεταμόσχευση αιμοποιητικών στελεχιαίων κυττάρων μυελού ή περιφερικού αίματος από εθελοντές μη συγγενείς ή απλοταυτόσημους δότες.
    • Χορήγηση κυττάρων ως θεραπεία μίας ή πολλαπλών λοιμώξεων/αναζωπυρώσεων από οποιονδήποτε εκ των 3 ιών : CMV, EBV και ΒΚ
    • Στεροειδή ≤0.5mg/kg πρεδνιζόνης ημερησίως
    • Σκορ Karnofsky/Lansky ≥50
    • ANC > 500/μl
    • Χολερυθρίνη ≤ 2x*, AST < 3x*, Κρεατινίνη ορού ≤ 2x*, (*=του μέγιστου φυσιολογικού ορίου), Αιμοσφαιρίνη> 8.0 g/dl.
    • Παλμική οξυμετρία > 90% σε αέρα δωματίου.
    • Διαθέσιμα VSTs πολλαπλής ειδικότητας.
    • Αρνητικό τεστ εγκυμοσύνης για τις θήλεις ασθενείς εάν είναι εφαρμόσιμο.
    • Έγγραφη συγκατάθεση από τον ασθενή, τον γονέα ή τον κηδεμόνα.
    E.4Principal exclusion criteria
    • Patients receiving ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
    • Patients with other uncontrolled infections (see protocol chapter 2.3.2)
    • Patients receiving steroids: >0.5mg/kg/daily prednisone
    • Patients who received donor lymphocyte infusion (DLI) within 28 days.
    •Patients with active acute GVHD grades II-IV.
    •Active and uncontrolled relapse of malignancy
    • Λήψη ATG, ή Campath ή άλλου μονοκλωνικού αντίσώματος που καταστέλλει τα Τ-λεμφοκύτταρα τις τελευταίες 28 ημέρες.
    • Εμφάνιση άλλων μη ελεγχόμενων λοιμώξεων (κεφάλαιο 2.3.2 πρωτόκολλο).
    • Λήψη στεροειδών: >0.5mg/kg πρεδνιζόνης ημερησίως.
    • Λήψη λεμφοκυττάρων του δότη τις τελευταίες 28 ημέρες.
    • Ενεργή οξεία GvHD ≥ βαθμού III-IV.
    • Ενεργή και μη ελεγχόμενη υποτροπή της κακοήθους νόσου.
    E.5 End points
    E.5.1Primary end point(s)
    1) Feasibility and safety of cell therapy with VSTs. The safety end point will be assessed based on: i) development of de novo GvH or progression to acute GvHD grades III-IV, ii) development of grades 3-5 infusion-related adverse events and iii) grades 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities
    2) Efficacy of VSTs will be assesed based on:
    • viral load
    • anti-viral immune reconstitution
    • viral reactivations
    1) Δυνατότητα εφαρμογής και ασφάλεια της κυτταρικής θεραπείας με VSTs. Το καταληκτικό σημείο για την ασφάλεια θα εκτιμηθεί βάσει: i) της εμφάνισης ή προόδου σε οξεία GvHD βαθμού III-IV, ii) της εμφάνισης επιπλοκών σχετιζόμενων με την έγχυση, βαθμού 3-5 και iii) μη αιματολογικών παρενεργειών βαθμού 4-5, οι οποίες δεν οφείλονται σε προϋπάρχουσες λοιμώξεις/συννοσηρότητες ή στην αρχική κακοήθεια.
    2) Αποτελεσματικότητα των VSTs, η οποία θα εκτιμηθεί με βάση :
    • το ιικό φορτίο των ασθενών.
    • την αποκατάσταση της αντιικής ανοσίας.
    • τις ιικές αναζωπυρώσεις.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Safety:
    • development of de novo GvH or progression to acute GvHD of grade III-IV within 42 days post last infusion of VSTs,
    • development of grade 3-5 infusion-related adverse events and grade 4-5 nonhematological adverse events that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbiditieswithin 30 days post last infusion of VSTs
    2) Efficacy: weeks 1,2,4,6 and 8, and month 3. Additional timepoints if clinically relevant
    1) σε σχέση με την ασφάλεια:
    • εμφάνιση ή πρόοδος σε οξεία GvHD βαθμού III-IV μέσα σε 42 ημέρες μετά την τελευταία χορήγηση VSTs,
    • εμφάνιση επιπλοκών σχετιζόμενων με την έγχυση, βαθμού 3-5 και μη αιματολογικών παρενεργειών βαθμού 4-5 μέχρι 30 ημέρες από την τελευταία χορήγηση VSTs, οι οποίες δεν οφείλονται σε προϋπάρχουσες λοιμώξεις/συννοσηρότητες ή στην αρχική κακοήθεια.
    2) Σε σχέση με την αποτελεσματικότητα τις εβδομάδες 1,2,4,6 και 8, καθώς και τον 3ο μήνα. Εάν ενδείκνυται κλινικά, μπορεί να εκτιμηθούν και πρόσθετα χρονικά σημεία.
    E.5.2Secondary end point(s)
    non applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    non applicable
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Administration of virus-specific T cells in transplant recipients for the first time in Greece
    χορήγηση αντι-ιικών Τ-λεμφοκυττάρων σε μεταμοσχευμένους ασθενείς για πρώτη φορά στην Ελλάδα
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 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
    10 months post LVLS for data analysis
    10 μήνες μετά LVLS για ανάλυση δεδομένων
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned 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: 20
    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 Yes
    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.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)
    As mentioned in the protocol and required for the post transplant care of the patients
    Όπως αναφέρεται στο πρωτ/λο και απαιτείται για την μεταμεταμοσχευτική φροντίδα των συμμετεχόντων
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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