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    Summary
    EudraCT Number:2013-003191-12
    Sponsor's Protocol Code Number:TUD-2DAUNO-058
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-26
    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 - BfArM
    A.2EudraCT number2013-003191-12
    A.3Full title of the trial
    Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of in-duction therapy for adult patients with acute myeloid leukemia ≤65 years
    Randomisierter Vergleicher zwischen zwei Dosierungen von Daunorubicin und zwischen Einfach- und Doppel-Induktionstherapie bei erwachsenen Patienten mit Akuter Myeloischer Leukämie ≤ 65 Jahre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of in-duction therapy for adult patients with acute myeloid leukemia ≤65 years
    A.3.2Name or abbreviated title of the trial where available
    DAUNODOUBLE
    A.4.1Sponsor's protocol code numberTUD-2DAUNO-058
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT02140242
    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 supportUCC Dresden
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversitätsklinikum Dresden
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Fakultät der TU Dresden
    B.5.2Functional name of contact pointMK I Bereich Klinische Studien
    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 number04903514583965
    B.5.5Fax number04903514584367
    B.5.6E-mailannett.haake@uniklinikum-dresden.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/08/585
    D.3 Description of the IMP
    D.3.1Product nameDaunoblastin
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaunorubicin
    D.3.9.3Other descriptive nameDAUNORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01556MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Newly diagnosed AML other than acute promyelocytic leukemia (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 acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
    Patients at the age of 18 to 65 years.
    Patienten mit neu diagnostizierter AML nach WHO-Kriterien (Blastenanteil ≥20%; ausgeschlossen ist akute promyelozytische Leukämie (APL)), Patienten mit sekundärer AML können ebenfalls eingeschlossen werden.
    Patienten müssen im Alter von 18-65 Jahren sein.
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed AML other than acute promyelocytic leukemia (APL) at the age of 18 - 65 years
    Patienten mit neu diagnostizierter AML; ausgeschlossen ist akute promyelozytische Leukämie (APL)
    Patienten müssen im Alter von 18-65 Jahren sein.
    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 10000886
    E.1.2Term Acute myeloid 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 10066353
    E.1.2Term Treatment related acute myeloid 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 10000887
    E.1.2Term Acute myeloid leukemia in remission
    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 10054294
    E.1.2Term Acute myeloid leukemia (in remission)
    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
    - Trial part I: To investigate whether a higher dose of daunorubicin in induction chemotherapy leads to an in-crease in good responders defined as having <5% myeloid blasts on day 15 after start of induction
    - Trial part II: To investigate whether the rate of CR/CRi after single induction is similar to that after double induction in patients with a good response to induction I.
    - Studienteil I: Es soll untersucht werden, ob eine höhere Dosis Daunorubicin in der Induktionstherapie zu einem höheren Anteil von Patienten mit gutem Therapieansprechen führt (definiert als <5% Knochenmark-Blasten 15 Tage nach Beginn der Induktionstherapie).
    - Studienteil II: Es soll bei Patienten mit gutem Ansprechen auf die erste Induktion untersucht werden, ob die Rate an kompletten Remissionen (CR; CRi) nach einer einmaligen Induktion vergleichbar ist mit der nach doppelter Induktion.
    E.2.2Secondary objectives of the trial
    - To investigate whether a higher dose of daunorubicin in induction chemotherapy will lead to an increase in cytogenetic and molecular complete remissions.
    - To investigate whether a higher dose of daunorubicin will lead to improved event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS).
    - To investigate whether EFS, RFS and OS is similar after single versus double induction in patients with good response to induction I.
    - To investigate a possible correlation between the level of cytogenetic and molecular minimal residual disease after induction treatment with survival outcomes EFS, RFS and OS.
    - Es soll untersucht werden, ob eine höhere Daunorubicindosis in der Induktionstherapie zu einer Erhöhung der kompletten molekularen und zytogenetischen Remissionen (CRm; CRc) führt.
    - Es soll untersucht werden, ob eine höhere Daunorubicindosis das Ereignis-freie Überleben (EFS), das Rezidiv-freie Überleben (RFS) und das Gesamtüberleben (OS) verbessert.
    - Es soll bei Patienten mit gutem Ansprechen auf die erste Induktion untersucht werden, ob EFS, RFS und OS nach einmaliger Induktion vergleichbar zur doppelten Induktion sind.
    - Es soll die Höhe der molekularen und zytogenetischen minimalen Resterkrankung nach der Induktionstherapie mit den Überlebensraten (EFS, RFS und OS) korreliert werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Newly diagnosed AML other than acute promyelocytic leukemia (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 acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
    - Age 18-65 years
    - ECOG performance status 0-2
    - Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 10 days prior to Day 1/Baseline:
    o Total bilirubin ≤ 1.5 times the upper limit of normal
    o ALT and AST ≤ 2.5 times upper limit of normal
    o Creatinine ≤ 1.5 times upper limit of normal
    - Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by transthoracal twodimensional echocardiography (“M Mode”) or MUGA scan
    - Signed Informed Consent
    - Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
    o Post-menopausal (12 months of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
    o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
    o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
    o Sexual abstinence
    o Vasectomy of the sexual partner
    - neu diagnostizierte AML nach WHO-Kriterien (ausgeschlossen ist die Akute Promyelozyten-Leukämie (APL)), d.h. Knochenmarksaspirate- oder Biopsien müssen ≥20% myeloischen Blastenanteil unter allen kernhaltigen Zellen oder das Differentialblutbild ≥20% Blasten aufweisen. Im Falle einer akuten erythroiden Leukämie müssen ≥20% Blasten in den nicht-erythroiden Knochenmarkszellen vorhanden sein. Bei AMLs, welche durch zytogenetische Abberationen gekennzeichnet ist, kann die Anzahl der Blasten <20% liegen. Patienten mit sekundärer AML können ebenfalls eingeschlossen werden.
    - Alter 18-65 Jahre
    - ECOG performance status 0-2
    - adäquate Leber- und Nierenfunktion (folgende innerhalb von 10 Tagen vor Tag 1/Baseline zu erhebende Laborgrenzwerte sind einzuhalten)
    o Gesamt-Bilirubin ≤ 1,5-faches des oberen Normalwertes
    o ALT und AST ≤ 2,5-faches des oberen Normalwertes
    o Kreatinin ≤ 1,5-faches des oberen Normalwertes
    - ausreichende Herzfunktion, d.h. links-ventrikuläre Auswurffraktion (LVEF) von ≥50% ermittelt durch transthorakale zwei-dimensionale Echokardiographie (“M Mode”) oder MUGA-Scan
    - unterzeichnete Einverständniserklärung
    - Frauen müssen mindestens eines der folgenden Kriterien für einen Studieneinschluss erfüllen:
    o post-menopausal (12 Monate natürliche Amenorrhöe oder 6 Monate Amenorrhöe mit Serum-FSH >40 U/ml)
    o postoperativ (d.h. 6 Wochen) nach bilateraler Ovariektomie mit oder ohne Hysterektomie
    o kontinuierliche und korrekte Anwendung kontrazeptiver Methoden mit einem Pearl-Index von <1% (z.B. Implantate, Depots, orale Kontrazeptiva, Intrauterinpessar (IUD))
    o sexuelle Abstinenz
    o Vasektomie des Sexualpartners
    E.4Principal exclusion criteria
    - Patients who are not eligible for standard chemotherapy as assessed by the treating physician
    - Central nervous system manifestation of AML
    - Cardiac disease: i.e. heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
    - Patients undergoing renal dialysis
    - Chronic pulmonary disease with clinical relevant hypoxia
    - Known HIV or Hepatitis infection
    - Uncontrolled active infection
    - Medical conditions other than AML with an estimated life expectancy below 6 months
    - Previous treatment of AML except hydroxyurea up to 5 days
    - Relapsed or primary refractory AML
    - Acute promyelocytic leukemia
    - Previous anthracyclin-containing chemotherapy
    - Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
    - Incapability of understanding purpose and possible consequences of the trial
    - Pregnant or breastfeeding women
    - Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
    - Patienten, die nach Einschätzung des behandelnden Arztes nicht für eine Standardchemotherapie geeignet sind
    - Manifestation der AML im zentralen Nervensystem
    - Herzerkrankungen: d.h. Herzinsuffizienz NYHA III-IV; instabile koronare Herzkrankheit (ein Myokardinfarkt, der mehr als 6 Monate zurück liegt ist erlaubt); schwerwiegende kardiale ventrikuläre Arrhythmien, die eine anti-arrhythmische Therapie erfordern
    - dialysepflichtige Patienten
    - chronische pulmonale Erkrankungen mit einer klinisch relevanten Hypoxie
    - bekannte HIV- oder Hepatitisinfektion
    - unkontrollierte aktive Infektion
    - andere Erkrankungen(außer AML), die mit einer Lebenserwartung von unter 6 Monaten einhergehen
    - vorherige zytostatische Behandlung der AML (Hydroxyurea bis 5 Tage erlaubt)
    - rezidivierte oder primär refraktäre AML
    - Akute Promyelozyten-Leukämie (APL)
    - vorherige Anthracyclin-haltige Chemotherapie
    - bekannte Behandlung mit nicht zugelassenen Medikamenten, Substanzen oder experimentelle Behandlung innerhalb von 4 Wochen vor Studieneinschluss
    - Unvermögen des Patienten Wesen und Tragweite oder mögliche Konsequenzen der Studie zu verstehen
    - schwangere oder stillende Frauen
    - Hinweise, die darauf hindeuten, dass der Patient den Anweisungen der Studienärzte oder dem Protokoll nicht folgen werden (z. B. fehlende Compliance)
    E.5 End points
    E.5.1Primary end point(s)
    - Trial part I: Rate (percentage) of good responders two weeks after start of induction defined by the presence of <5% myeloid blasts on day 15 after start of IT.
    - Trial part II: Rate (percentage) of complete hematological remissions (CR; CRi) as defined by standard criteria [Döhner 2010] after induction treatment.
    - Studienteil I: Rate (in %) an Patienten mit gutem Therapieansprechen 2 Wochen nach Beginn der die ersten Induktion (definiert als <5% myeloischer Blasten im Knochenmark).
    - Studienteil II: Rate (in %) kompletter hämatologischer Remissionen (CR; CRi) nach Abschluss der Induktionstherapie (definiert nach Standardkriterien [Döhner 2010])
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Trial part I: 15 days after start of induction I
    - Trial part II: day 35 after start of last in-study induction
    - Studienteil I: 15 Tage nach Beginn der ersten Induktionstherapie
    - Studienteil II: 35 Tage nach Beginn der letzten Induktionstherapie, die innerhalb der Studie durchgeführt wird
    E.5.2Secondary end point(s)
    - Efficacy Endpoints:
    o Rate of complete molecular and cytogenetic remissions
    o Event-free survival
    o Relapse-free survival
    o Overall survival
    - Safety Endpoints:
    o Rate of early deaths (2 weeks) and induction deaths (until day 60 or beginning of consolidation treatment – whichever occurs first)
    o Incidence of serious infectious complications (Grades 3-4 CTCAE V4.0)
    o Incidence of CTCAE grade ≥3 cardiac complications
    - Effektivitätsendpunkte:
    o Rate kompletter molekularer und zytogentischer Remissionen
    o Ereignis-freies Überleben (EFS)
    o Rezidiv-freies Überleben (RFS)
    o Gesamtüberleben (OS)
    - Safety-Endpunkte:
    o Rate an frühen Todesfällen (innerhalb von 2 Wochen) und Induktionstodesfällen (bis 60 Tage nach Beginn der letzten Induktion innerhalb der Studie oder bis Beginn der Konsolidierungstherapie – je nach dem was eher zutrifft)
    o Inzidenz schwerer infektiöser Komplikationen (Grad 3-4 CTCAE V4.0)
    o Inzidenz von kardialen Komplikationen (CTCAE Grad ≥3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy Endpoints: day 35 after start of last in-study induction; 2 years
    - Safety Endpoints: regulary; within 2 weeks after start of induction; until day 60 or beginning of consolidation treatment – whichever occurs first
    - Effektivitätsendpunkte:
    35 Tage nach Beginn der letzten Induktionstherapie, die innerhalb der Studie durchgeführt wird; 2 Jahre
    - Safety-Endpunkte:
    regelmäßig; innerhalb von 2 Wochen nach Start der Induktion; bis 60 Tage nach Start der letzten Induktion innerhalb der Studie bzw. bis Start der Konsolidierungstherapie
    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 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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    gleiches Arzneimittel; Vergleich als Standarddosierung
    same medicinal product using standard dose
    E.8.2.4Number of treatment arms in the trial4
    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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    last patient last visit (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 years
    E.8.9.1In the Member State concerned months55
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months55
    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: 568
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 568
    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 state568
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 568
    F.4.2.2In the whole clinical trial 568
    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)
    Further treatment for Patients who drop out will continue outside the clinical trial at the discretion of the treating physician.
    Die Patienten, die aus der Studie vorzeitig ausscheiden, erhalten die weitere Behandlung außerhalb der Studie in Absprache mit dem jeweiligen behandelnden Arzt.
    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 Study Alliance Leukemia (SAL)
    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 Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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