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    Summary
    EudraCT Number:2012-003033-42
    Sponsor's Protocol Code Number:UKER-BLZ-PH1
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-26
    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 - PEI
    A.2EudraCT number2012-003033-42
    A.3Full title of the trial
    Prospective, open-label, multicentre clinical trial, phase I/IIa, to investigate the safety and tolerability of allogeneic B-cell concentrates CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses for immune response enhancement, measured as response to a preponed single vaccination
    Prospektive, offene, multizentrische klinische Prüfung der Phase I/IIa zur Untersuchung der Sicherheit und Verträglichkeit von allogenen
    B-Zellkonzentraten CD3+-depletiert, CD19+-angereichert, kryokonserviert (einmalig appliziert nach Tag 120 nach allogener Stammzelltransplantation, Spender-ident) in 4 Gruppen mit eskalierenden Dosisstufen zur Verbesserung der Immunantwort, gemessen am Ansprechen auf eine vorgezogene Einzelvakzinierung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label clinical trial, phase I/IIa, at several study sites to investigate the safety and tolerability of selected deep-frozen immune cells from a donor in patients who underwent a stem cell transplantation, for the enhancement of the immune response, measured as response to an early vaccination. Patients receive a single dose of the study medication after day 120 following the stem cell transplantation. Increasing doses are administered to subsequent groups of patients.
    Offene klinische Prüfung, Phase I/IIa, an mehreren Studienzentren zur Untersuchung der Sicherheit und Verträglichkeit von ausgewählten gefrorenen Immunzellen eines Spenders in Patienten, die eine Stammzelltransplantation erhalten haben, zur Verbesserung der Immunantwort, gemessen am Ansprechen auf eine frühe Impfung. Die Patienten erhalten dabei das Prüfpräparat einmalig nach Tag 120 nach Transplantation. Ansteigende Dosen werden aufeinanderfolgenden Gruppen von Patienten verabreicht.
    A.3.2Name or abbreviated title of the trial where available
    B-cell therapy trial
    B-Zelltherapie-Studie
    A.4.1Sponsor's protocol code numberUKER-BLZ-PH1
    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 SponsorUniversitätsklinikum Erlangen
    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 supportDeutsche Forschungsgemeinschaft e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointMedizinische Klinik 5
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318543112
    B.5.5Fax number+4991318535984
    B.5.6E-mailjulia.winkler@uk-erlangen.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 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 nameAllogeneic B-cell concentrate CD3+-depleted, CD19+-enriched, cryopreserved
    D.3.4Pharmaceutical form Suspension 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 INNAllogeneic B-lymphocytes
    D.3.9.3Other descriptive nameALLOGENEIC B-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB112494
    D.3.10 Strength
    D.3.10.1Concentration unit thousand organisms/ml thousand organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6000
    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) Yes
    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
    Status post allogeneic stem cell transplantation
    Zustand nach allogener Stammzelltransplantation
    E.1.1.1Medical condition in easily understood language
    Status after transplantation of blood stem cells from a donor
    Zustand nach Transplantation von Blutstammzellen eines Spenders
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10067862
    E.1.2Term Allogeneic stem cell transplantation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of escalating doses of the study medication in patients after allogeneic stem cell transplantation (donor-identical)
    Untersuchung der Sicherheit und Verträglichkeit von aufsteigenden Dosen des Prüfpräparats in Patienten nach allogener Stammzelltransplantation (Spender-ident)
    E.2.2Secondary objectives of the trial
    Assessment of the effect of the study medication on the secondary immune response to a preponed single vaccination with a combined vaccine against DTPa-IPV-Hib and Prevenar 13
    Detection of indications for the efficacy of the study medication
    Bestimmung des Einflusses des Prüfpräparats auf die sekundäre Immunantwort auf eine vorgezogene Einzelvakzinierung mit einem Kombinationsimpfstoff gegen DTPa-IPV-Hib und Prevenar 13
    Ermittlung von Anhaltspunkten für die Wirksamkeit des Prüfpräparats
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female person aged 18 to 75 years.
    2. Written informed consent of the patient.
    3. Day 100±10 days after allogeneic stem cell transplantation.
    4. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+.
    7. Females must in addition meet at least one of the following criteria:
    menopause (minimum amenorrhoea for 12 months oder amenorrhoea for 6 Monate with serum FSH >40mU/ml) or bilateral ovarectomy or hysterectomy or vasectomy of her partner (all in medical history) or routine, correct and consequent use of a contraceptual method with a failure rate of <1%/year.
    1. Männliche oder weibliche Person im Alter von 18 bis 75 Jahre.
    2. Schriftlichen Einwilligung des Patienten/der Patientin
    3. Zustand nach allogener SZT im Zeitraum von 100±10 Tagen vor Studieneinschluss.
    4. Serostatus für EBV: R-/D- oder R+/D- oder R+/D+.
    7. Frauen müssen zusätzlich mindestens eines der folgenden Kriterien erfüllen:
    Menopause (mindestens 12 Monate natürliche Amenorrhoe oder 6 Monate Amenorrhoe mit Serum-FSH >40mU/ml) oder Zustand nach beidseitiger Ovarektomie oder Zustand nach Hysterektomie oder Vasektomie des Partners
    oder regelmäßige, korrekte und konsequente Anwendung einer Verhütungsmaßnahme mit Fehlerquote <1%/Jahr.
    E.4Principal exclusion criteria
    1. Serostatus for EBV: R-/D+.
    2. Severe acute GvHD (Glucksberg grade III und IV).
    3. Chronic GvHD in middle- or high-risk group according to NIH staging.
    4. Rituximab administration after SCT.
    5. >10.000 EBV DNA copies/ml plasma.
    6. Recurrence of the haematological disorder needing therapeutic intervention.
    7. Secondary transplantation.
    8. SCT with transplat from a haploidentical donor.
    9. SCT with transplant from umbilical cord blood.
    10. CD34+-enriched transplant.
    11. in vitro T-cell depleted transplant.
    12. Pregnant or breast-feeding female.
    1. Serostatus für EBV: R-/D+.
    2. Schwere akute GvHD (Grad III und IV nach Glucksberg).
    3. Chronische GvHD der Mittel- und Hochrisikogruppe nach NIH-Staging.
    4. Therapie mit Rituximab im gesamten Zeitraum nach SZT.
    5. >10.000 EBV-DNA Kopien/ml Plasma.
    6. Behandlungsbedürftiges Rezidiv der hämato-onkologischen Grunderkrankung.
    7. Zweittransplantation.
    8. SZT mit Transplatat eines haploidenten Spenders.
    9. SZT mit Transplantat aus Nabelschnurblut.
    10. CD34+-angereicherte Transplantate.
    11. in vitro T-Zell-depletierte Transplantate.
    12. Schwangere oder stillende Frauen.
    E.5 End points
    E.5.1Primary end point(s)
     Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs between dose groups.
     Difference in number, duration and severity of AESIs between dose groups.
     Change in number of EBV DNA copies/ml plasma).
     Frequency of >50,000 EBV DNA copies/ml plasma).
     Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD).
     Anzahl, Dauer und Ausprägung von AEs, ARs, SAEs, SARs und SUSARs im Vergleich zwischen den vier Dosigruppen.
     Anzahl, Dauer und Ausprägung von AESIs im Vergleich zwischen den vier Dosisgruppen.
     Anstieg der EBV-Viruslast (DNA-Kopien/ml Plasma).
     Auftreten einer behandlungsbedürftigen EBV-Viruslast (>50.000 Kopien/ml Plasma).
     Auftreten von Zeichen einer lymphoproliferativen Erkrankung nach Transplantation (PTLD).
    E.5.1.1Timepoint(s) of evaluation of this end point
     Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs: before and after administration of study medication.
     Difference in number, duration and severity of AESIs: after administration of study medication.
     Change in number of EBV DNA copies/ml plasma: before and after administration of study medication.
     Frequency of >50,000 EBV DNA copies/ml plasma after administration of study medication.
     Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD): after administration of study medication.
     Anzahl, Dauer und Ausprägung von AEs, ARs, SAEs, SARs und SUSARs: vor und nach Gabe des Prüfpräparats.
     Anzahl, Dauer und Ausprägung von AESIs: nach Gabe des Prüfpräparats.
     Anstieg der EBV-Viruslast: vor und nach Gabe des Prüfpräparats.
     Auftreten einer behandlungsbedürftigen EBV-Viruslast: nach Gabe des Prüfpräparats.
     Auftreten von Zeichen einer PTLD: nach Gabe des Prüfpräparats.
    E.5.2Secondary end point(s)
     Difference in mean change in the frequency of antibody-producing cells between dose groups.
     Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups.
     Difference in mean change of antigen-specific antibody concentration in serum/plasma between dose groups
     Differnce in mean change of CMV DNA copies/ml plasma between dose groups.
     Differenz in number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.
     Mittlere Veränderung der Frequenz der Antikörper-produzierenden Zellen im Vergleich zwischen den vier Dosisgruppen.
     Veränderung der mittleren absoluten Zellzahl der B-Lymphozyten, der naiven
    B-Lymphozyten und der Gedächtnis-B-Lymphozyten im Vergleich zwischen den vier Dosisgruppen.
     Mittlere Veränderung der antigenspezifischen Antikörper-Konzentration im Serum/Plasma im Vergleich zwischen den vier  Mittlere Veränderung der CMV-Viruslast (DNA-Kopien/ml Plasma) im Vergleich zwischen den vier Dosisgruppen.
     Anzahl der Patienten mit behandlungsbedürftiger CMV-Viruslast (>5.000 DNA-Kopien/ml Plasma) oder Zeichen eines CMV-Organbefalls im Vergleich zwischen den vier Dosisgruppen.
    E.5.2.1Timepoint(s) of evaluation of this end point
     Difference in mean change in the frequency of antibody-producing cells: before and after preponed single vaccination.
     Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes: before and after administration of study medication.
     Difference in mean change of antigen-specific antibody concentration in serum/plasma: before and after administration of study medication.
     Difference in mean change of CMV DNA copies/ml plasma): before and after administration of study medication.
     Differenz in number of patients with >5,000 CMV DNA copies/ml plasma) or with signs of organ infestation by CMV: after administration of study medication.
     Mittlere Veränderung der Frequenz der Antikörper-produzierenden Zellen: vor und nach der vorgezogenen Einzelvakzinierung.
     Veränderung der mittleren absoluten Zellzahl der B-Lymphozyten, der naiven
    B-Lymphozyten und der Gedächtnis-B-Lymphozyten: vor und nach Gabe des Prüfpräparats.
     Mittlere Veränderung der antigenspezifischen Antikörper-Konzentration im Serum/Plasma: vor und nach Gabe des Prüfpräparats.
     Mittlere Veränderung der CMV-Viruslast (DNA-Kopien/ml Plasma): vor und nach Gabe des Prüfpräparats.
     Anzahl der Patienten mit behandlungsbedürftiger CMV-Viruslast (>5.000 DNA-Kopien/ml Plasma) oder Zeichen eines CMV-Organbefalls: nach Gabe des Prüfpräparats.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    Dosiseskalation in aufeinanderfolgenden Gruppen
    Dose escalation in sequential groups
    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 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 concerned4
    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 No
    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 Studienteilnehmers
    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 months2
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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.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
    Keine
    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 Decision2013-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-21
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