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    Summary
    EudraCT Number:2010-022388-37
    Sponsor's Protocol Code Number:TUD-RELA02-048
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-15
    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 number2010-022388-37
    A.3Full title of the trial
    Treatment of patients with MDS or AML with an impending hematological relapse with Azacitidin (Vidaza)
    Behandlung des drohenden hämatologischen Rezidivs von Patienten mit MDS oder AML mit Azacitidin (Vidaza®)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of an imminent recurrence of the disease in patients with a Myelodysplastic syndrome or acute myeloid leukemia with azacitidine (Vidaza®)
    Behandlung eines drohenden Wiederauftreten der Erkrankung von Patienten mit einem Myelodisplastischen Syndrom oder einer akuten myeloischen Leukämie mit Azacitidin (Vidaza®)
    A.3.2Name or abbreviated title of the trial where available
    RELAZA2
    A.4.1Sponsor's protocol code numberTUD-RELA02-048
    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 supportDresden University of Technology
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCelgene International
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Fakultät der TU Dresden, Medizinische 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 number+49351458-02583
    B.5.5Fax number+49351458-04367
    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 Vidaza®
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/084
    D.3 Description of the IMP
    D.3.1Product nameVidaza
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with AML or MDS >= 18 years of age after conventional chemotherapy or stem cell transplantation with significant residual disease or an increase of MRD (e.g. t(6,9), NPM1 or CD34+ or CD117+ in case of PBSC Tx)
    Patienten (Alter ≥18 Jahre) mit MDS oder AML nach konventioneller Chemotherapie oder allogener HSZT und einem verfügbaren molekularen Marker wie t(6,9), NPM1 oder CD34+ oder CD117+ im Falle einer allogenen HSZT
    E.1.1.1Medical condition in easily understood language
    Patients (≥18 years) with MDS o. AML following treatment with chemotherapy or stem cell transplantation with detectable residual disease or a recurrence of the disease
    Patienten (≥18 J.) mit MDS o. AML nach Behandlung mit Chemotherapie oder Stammzelltransplantation mit nachweisbarer Resterkrankung oder einem Wiederauftreten der Erkrankung
    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 10060557
    E.1.2Term Acute myelocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028534
    E.1.2Term Myelodysplastic syndrome NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in MDS or AML patients with significant residuals or an increase of minimal residual disease (MRD) which is defined as
    - decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
    - Increase in the AML-specific molecular markers in the quantitative PCR for t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy or allogeneic HSCT or
    - Persistence of the (above) MRD level >1% after conventional chemotherapy or allogeneic HSCT
    Untersuchung der Wirksamkeit von Azacitidin 6 Monate nach Beginn der Therapie in der Verhinderung des hämatologischen Rezidivs bei MDS oder AML Patienten mit signifikanten Residuen bzw. einem Anstieg der minimalen Resterkrankung (MRD) definiert als
    - Abfall des CD34 Spenderchimärismus (<80%) nach allogen verwandter oder unverwandter HSZT bei CD34+ oder CD117+ MDS o. AML oder
    - Anstieg des AML spezifischen molekularen Markers in der quantitativen PCR für t(6,9), NPM1+ AML >1% (Ratio zu Referenzgen) nach erfolgter konventioneller Chemotherapie oder allogener HSZT oder
    - Persistenz des (o.g.) MRD Niveaus >1 % nach erfolgter konventioneller Chemotherapie oder allogener HSZT
    E.2.2Secondary objectives of the trial
    - tolerance of azacitidine
    - quality of the response of the MRD (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
    - Modulation of CD34+, NK- and T- cells of MDS and AML patients by azacitidine
    - Investigation of predictive molecular markers
    - Analysis of immunomodulatory regulators
    - Verträglichkeit von Azacitidin
    - Die Untersuchung der Qualität des Ansprechens der MRD (major vs. minor) sowie des Rezidiv-freien Überlebens und Gesamtüberleben 12, 24 und 30 Monate nach Beginn der Behandlung mit Azacitidin
    - Modulierung der CD34+ sowie NK- und T-Zellen von MDS und AML Patienten durch Azacitidin
    - Untersuchung prädiktiver molekularer Marker
    - Analyse immunmodulatorischer Regulatoren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening:
    - signed informed consent
    - Age ≥18 years
    - patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(6,9), NPM1 pos. or CD34+ or CD117+ in the case of an allogeneic HSCT (CD34+/CD117+ positivity of blasts ≥ 10% at any time prior to HSCT)
    Treatment:
    - MDS or AML without haematological relapse (blasts <5% in the bone marrow), and
    - decrease of CD34+ or CD117+ donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ MDS or AML or
    - increase in the AML-specific molecular marker in the quantitative PCR for t(6,9), NPM1+ AML >1% after conventional chemotherapy or allogeneic HSCT or
    - persistence of the (above) MRD levels >1% (relative to the reference gene) after conventional chemotherapy or allogeneic HSCT
    - leukocytes > 3 Gpt/l and platelets >75 Gpt/l (transfusion independent)
    Screeningphase:
    - Schriftliche Einwilligung des Patienten nach erfolgter Aufklärung
    - Alter ≥ 18 Jahre
    - Patienten mit MDS bzw. AML nach konventioneller Chemotherapie oder allogener HSZT und einem verfügbaren molekularen Marker wie t(6,9), NPM1 pos. oder CD34+ oder CD117+ im Falle einer allogenen HSZT (CD34+/CD117+-Positivität der Blasten von ≥ 10% zu einem beliebigen Zeitpunkt vor HSZT)
    Behandlungsphase:
    - MDS oder AML ohne hämatologisches Rezidiv (Blasten < 5% im Knochenmark) sowie
    - Abfall des CD34 Spenderchimärismus (<80%) nach allogen verwandter oder unverwandter HSZT bei CD34+ oder CD117+ MDS o. AML oder
    - Anstieg des AML spezifischen molekularen Markers in der quantitativen PCR für t(6,9), NPM1+ AML >1% nach erfolgter konventioneller Chemotherapie oder allogener HSZT oder
    - Persistenz des (o.g.) MRD Niveaus >1% (bezogen auf das Referenzgen) nach erfolgter konventioneller Chemotherapie oder allogener HSZT
    - Leukozyten > 3 Gpt/l und Thrombozyten > 75 Gpt/l (transfusionsunabhängig)
    E.4Principal exclusion criteria
    - Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
    - Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
    - addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation
    - pregnant or breast feeding women
    - women of childbearing potential, except women who meet the following criteria:
    o post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH> 40 U/ml)
    o postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy)
    o regular and proper use of a contraceptive method with error rate <1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD) during study treatment and up to 1 year after completion of therapy
    o sexual abstinence during study treatment and up to 1 year after completion of therapy
    o Vasectomy of the partner
    - Men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy:
    o sexual abstinence
    o State post-vasectomy
    o Condom
    - Evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation)
    - Uncontrolled active infection
    - Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
    - Dialysis dependent renal dysfunction
    - Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease

    These criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.
    - anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur,
    - Teilnahme der Patientin/des Patienten an einer anderen klinischen Prüfung innerhalb der letzten 4 Wochen vor dem Einschluss,
    - Sucht- oder sonstige Erkrankungen, die es der oder dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen,
    - schwangere oder stillende Frauen,
    - Frauen im gebärfähigen Alter, außer Frauen, die die folgenden Kriterien erfüllen:
    o post-menopausal (12 Monate natürliche Amenorrhoe oder 6 Monate Amenorrhoe mit Serum FSH > 40 mlU/ml)
    o postoperativ (6 Wochen nach Hysterektomie und/oder beidseitiger Ovarektomie)
    o regelmäßige und korrekte Anwendung einer Verhütungsmethode mit Fehlerquote <1% pro Jahr (z. B. Implantate, Depotspritzen, orale Kontrazeptiva, Intrauterinpessar–IUP) während der Studienbehandlung und bis 1 Jahr nach Abschluss der Therapie
    o sexuelle Enthaltsamkeit während der Studienbehandlung und bis 1 Jahr nach Abschluss der Therapie
    o Vasektomie des Partners
    - Männer, die während der Studienbehandlung und bis 1 Jahr nach Abschluss der Therapie nicht eine der nachfolgenden Varianten zur wirksamen Empfängnisverhütung nutzen:
    o Sexuelle Enthaltsamkeit
    o Zustand nach Vasektomie
    o Kondom
    - Anzeichen darauf, dass die teilnehmende Person den Prüfplan voraussichtlich nicht einhal-ten wird (z. B. mangelnde Kooperationsbereitschaft)
    - Nicht kontrollierbare bzw. aktive Infektionskrankheit
    - Schwere Leberfunktionsstörungen (ASAT und ALAT dürfen das Dreifache des Normwertes nicht überschreiten) oder Leberzirrhose oder maligner Lebertumor
    - Dialysepflichtige Nierenfunktionsstörung
    - Bekannte schwere dekompensierte Herzinsuffizienz, klinisch instabile Herzerkrankung oder Lungenerkrankung

    Bis auf eine bekannte allergische Reaktion auf bzw. Unverträglichkeit von Azacitidin gelten diese Kriterien nicht für die Screeningphase.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of treatment success (relapsed patients after 6 months of treatment)
    Rate der Patienten die ein hämatologisches Rezidiv 6 Monate nach Beginn der Therapie mit Azacitidin erleiden
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 months after start of treatment
    6 Monate nach Beginn der Therapie mit Azacitidin
    E.5.2Secondary end point(s)
    - Occurrence or exacerbation of a clinical relevant acute or chronic GvHD
    - Rate of infectious SAEs
    - Qualitative and quantitative changes by azacitidine in NK- and T-cells
    - Change of methylation in CD34+ cells
    - Major / minor response or relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
    - Frequency of PD-1 on T cells and PD-L1 on blasts
    - Mutation load of selected genes (eg DNMT3A, TET2) and their influence on the response
    - Auftreten bzw. Exazerbation klinisch relevanter akuter oder chronischer GvHD
    - Rate an infektiösen SAEs
    - Qualitative und quantitative Veränderungen von NK-und T-Zellen unter Azacitidin
    - Änderung der Methylierung in CD34+ Zellen
    - Majores/minores Ansprechen bzw. Rezidiv-freies Überleben und Gesamtüberleben 12, 24 und 30 Monate nach Beginn der Behandlung
    mit Azacitidin
    - Frequenz von PD-1 auf T-Zellen bzw. PD-L1 auf Blasten
    - Mutationslast ausgewählter Gene (z. B. DNMT3A, TET2) und deren Einfluss auf das Ansprechen
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months after start of therapy with Azacitidin
    30 Monate nach Start der Therapie mit Azacitidin
    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 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 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.8.2.4Number of treatment arms in the trial1
    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 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
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 state93
    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)
    provided in the protocol
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-10
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