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    Summary
    EudraCT Number:2011-003168-63
    Sponsor's Protocol Code Number:AMLSG16-10/CPKC412ADE02T
    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:2012-01-12
    Trial results View 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 number2011-003168-63
    A.3Full title of the trial
    Phase-II study evaluating midostaurin in induction, consolidation and
    maintenance therapy also after allogeneic blood stem cell transplantation
    in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
    Phase II Studie zu Midostaurin in der Induktions-, Konsolidierungs- und
    Erhaltungstherapie sowie nach allogener Blutstammzelltransplantation bei Patienten mit neu diagnostizierter akuter myeloischer Leukämie und
    Nachweis einer internen Tandemduplikation des FLT3-Gens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase-II study evaluating midostaurin in induction, consolidation and
    maintenance therapy also after allogeneic blood stem cell transplantation
    in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
    Phase II Studie zu Midostaurin in der Induktions-, Konsolidierungs- und
    Erhaltungstherapie sowie nach allogener Blutstammzelltransplantation bei Patienten mit neu diagnostizierter akuter myeloischer Leukämie und
    Nachweis einer internen Tandemduplikation des FLT3-Gens
    A.3.2Name or abbreviated title of the trial where available
    AMLSG 16-10
    A.4.1Sponsor's protocol code numberAMLSG16-10/CPKC412ADE02T
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01477606
    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 SponsorUniversity Hospital Ulm
    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 supportNovartis GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversity Hospital Ulm
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversiy Hospital Ulm
    B.5.2Functional name of contact pointHartmut Doehner
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Einstein-Allee 23
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number+4973150045951
    B.5.5Fax number+4973150045905
    B.5.6E-mailhartmut.doehner@uniklinik-ulm.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 Es werden nur in Deutschland zugelassene Arzneimittel für diese Studie verwendet
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCytarabine
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Concentrate and solvent for solution for 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 INNCYTARABINE
    D.3.9.1CAS number 147-94-4
    D.3.9.3Other descriptive nameCYTARABINE
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 4000
    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.IMP: 2
    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 If the IMP has a marketing authorisation in the Member State concerned by this application, but the trade name and marketing authorisation holder are not fixed in the protocol, go to section D.2.2.
    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.3.1Product nameMidostaurin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMidostaurin
    D.3.9.1CAS number 120685-11-2
    D.3.9.3Other descriptive nameMIDOSTAURIN
    D.3.9.4EV Substance CodeSUB21040
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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 Es werden nur in Deutschland zugelassene Arzneimittel für diese Studie verwendet
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDaunorubicin
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form 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 INNDAUNORUBICIN
    D.3.9.1CAS number 20830-81-3
    D.3.9.4EV Substance CodeSUB06917MIG
    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 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 confirmed diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
    -Neu diagnostizierte akute myeloische Leukämie mit Nachweis einer
    internen Tandemduplikation des FLT3-Gens (FLT3-ITD)
    -AMLverwandte myeloische Vorläufer Neoplasien nach WHO 2008 mit
    Nachweis einer FLT3-ITD
    -Akute Leukämie mit unklarer Linienzugehörigkeit nach WHO 2008 mit
    Nachweis einer FLT3-ITD
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic
    stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3- ITD.

    To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on OS in adult patients with AML exhibiting a FLT3-ITD.

    To perform two predefined subgroup analyses in the age-groups 18-60 years and 61-70 years evaluating the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) and Overall survival (OS) in adult patients with AML exhibiting a FLT3-ITD.
    Evaluation des Einflusses von Midostaurin in Kombination mit intensiver Induktions-, Konsolidierungs- und Erhaltungstherapie auch nach allogener Blutstammzelltransplantation auf das Ereignisfreie Überleben (EFS) bei erwachsenen Patienten mit AML und FLT3-ITD.

    Evaluation des Einflusses von Midostaurin in Kombination mit intensiver Induktions-, Konsolidierungs- und Erhaltungstherapie auch nach allogener Blutstammzelltransplantation auf das Gesamtüberleben (OS) bei erwachsenen Patienten mit AML und FLT3-ITD.

    Durchführung zweier vordefinierter Subgruppenanalysen in den Altersgruppen 18-60 Jahr und 61-70 Jahre zur Evaluation des Einflusses von Midostaurin in Kombination mit intensiver Induktions-, Konsolidierungs- und Erhaltungstherapie auch nach allogener Blutstammzelltransplantation auf das Ereignisfreie Überleben (EFS) und Gesamtüberlegen (OS) bei erwachsenen Patienten mit AML und FLT3-ITD.
    E.2.2Secondary objectives of the trial
    -Assessment of complete remission (CR) rate, cumulative incidence of relapse (CIR) , cumulative incidence of death (CID), relapse-free (RFS) and overall survival (OS)
    -Evaluation of target (FLT3) inhibition by continuous dosing of midostaurin
    - Assessment of the relative impact of allogeneic HSCT analyzed as time-dependent variable on survival endpoints.
    -Assessment of quality of live
    •Evaluation des Einflusses von Midostaurin in Kombination mit
    intensiver zytostatischer Chemotherapie auf die Rate an kompletten
    Remissionen (CR), die kumulative Inzidenz an Rezidiven (CIR) und
    Todesfällen (CID), das rezidivfreie (RFS) und Gesamtüberleben (OS)
    • Evaluation der Target-Inhibition (FLT3) durch Midostaurin
    • Evaluation des relativen Einflusses der allogenen Blutstammzelltransplantation als zeitabhängige Kovaraible auf Überlebensendpunkte
    • Bewertung der Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with confirmed diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
    • Presence of FLT3-ITD assessed in the central AMLSG reference laboratories
    • Patients considered eligible for intensive chemotherapy
    • WHO performance status of ≤ 2
    • Age ≥ 18 years and ≤ 70 years with the capacity to give informed consent
    • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤ 7 days)
    • Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration (“Women of childbearing potential” is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
    • Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 5 months after the last dose of chemotherapy
    • Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner’s vasectomy). Hormonal contraception is an inadequate method of birth control
    • Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 5 months after the last dose of chemotherapy)
    • Signed written informed consent.
    • Neu diagnostizierte AML, neu diagnostizierte AML verwandte myeloische Vorläufer Neoplasie, oder Akute Leukämie mit unklarer Linienzugehörigkeit nach WHO 2008 Kriterien, und
    • Nachweis einer FLT3-ITD, diagnostiziert in einer der beiden zentralen Referenzlaboratorien der AMLSG
    • Patient ist geeignet für eine intensive Chemotherapie
    • WHO Performance Status <= 2
    • Einwilligungsfähige Patienten, Alter >=18 Jahre und ≤ 70 Jahre
    • Keine vorangehende, die Leukämie betreffende Chemotherapie, mit Ausnahme von Hydroxyurea zur Kontrolle einer Hyperleukozytose (bis zu 7 Tage erlaubt)
    • Keine schwangeren oder stillenden Patientinnen: Frauen im fortpflanzungsfähigen Alter müssen einen negativen Schwangerschaftstest mit einer Sensitivität von mind. 25 mlU/mL (im Serum oder Urin) innerhalb 72 h vor der Registrierung aufweisen.
    • Männer müssen ihr Einverständnis geben, dass sie (während und bis fünf Monate nach Abschluss der Studienbehandlung (Erhaltungstherapie)) keine Nachkommen zeugen und müssen bei Geschlechtsverkehr mit einer Frau im gebärfähigen Alter ein Kondom benutzen, selbst wenn eine erfolgreiche Samenleiterdurchtrennung stattgefunden hat.
    • Frauen im fortpflanzungsfähigen Alter müssen ihr Einverständnis geben, dass sie während Therapie und bis fünf Monate nach Abschluss der Erhaltungstherapie eine Schwangerschaft vermeiden oder keine Nachkommen zeugen. Frauen im fortpflanzungsfähigen Alter müssen deshalb während Therapiebeginn und bis 5 Monate nach Therapieende eine effektive Verhütungsmethode anwenden. Sichere Verhütungsmethoden sind sexuelle Abstinenz oder Intrauterinpessar, Tubenligatur und Vasektomie des Partners. Hormonelle Kontrazeption ist keine akzeptable Verhütungsmethode.
    Frauen nach Gebärmutterentfernung oder ausgebliebener Regelblutung über 24 aufeinander folgende Monate benötigen keinen Schwangerschaftstest oder Verhütungsmethode.
    • Unterschriebene Einverständniserklärung
    E.4Principal exclusion criteria
    • AML with the following recurrent genetic abnormalities (according to WHO 2008):
    AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
    AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
    AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
    • Performance status WHO >2
    • Patients with ejection fraction < 50% ECHO scan within 14 days of day 1
    • Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
    • Uncontrolled infection
    • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
    • Patients with a “currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a “currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year
    • Known positive for HIV; active HBV, HCV, or Hepatitis A infection
    • Bleeding disorder independent of leukemia
    • No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
    • No consent for biobanking.
    • AML mit folgenden rekurrenten genetischen Veränderungen (gemäß WHO Klassifikation 2008):
    AML mit t(8;21)(q22;q22); RUNX1-RUNX1T1
    AML mit inv(16)(p13.1q22) oder t(16;16)(p13.1;q22); CBFB-MYH11
    AML mit t(15;17)(q22;q12); PML-RARA (oder variante Translokationen mit anderen RARA-Genfusionen)
    • Allgemeinzustand WHO > 2
    • Patienten mit Ejektionsfraktion < 50% nachgewiesen ECHO (innerhalb der letzten 14 Tage vor Tag 1)
    • Organinsuffizienz (Kreatinin > 1.5x obere Norm im Serum; Bilirubin, AST oder ALP > 2.5x obere Norm im Serum (falls nicht durch die AML-bedingt); Herzinsuffizienz NYHA III/IV; schwere obstruktive oder restriktive Ventilationsstörung)
    • Unkontrollierte Infektion
    • Schwere neurologische oder psychiatrische Störung, die das Verstehen und die freiwillige sowie selbständige Unterzeichnen der Einverständniserklärung einschränken oder unmöglich machen
    • Patienten mit einer aktiven zweiten Neoplasie (Ausnahme: Hauttumoren vom Nicht-Melanom-Typ). Patienten nach Abschluss der Therapie für die zweite Neoplasie und einer Rezidivwahrscheinlichkeit die kleiner als 30 % ist, sind für das Protokoll geeignet. Die Rezidivwahrscheinlichkeit wird vom behandelnden Arzt eingeschätzt.
    • Bekannte HIV Infektion; aktive Hepatitis A, Hepatitis B oder Hepatitis C Infektion
    • Blutungserkrankung unabhängig von der Leukämie
    • Kein Einverständnis für die Registrierung, Lagerung und Handhabung der personenbezogenen Krankheitsdaten und des Verlaufes sowie kein Einverständnis über die Information des Hausarztes und/oder anderer behandelnder Ärzte zur Studienteilnahme
    • Kein Einverständnis für das Biobanking im Rahmen der Studie
    E.5 End points
    E.5.1Primary end point(s)
    Event free Survival
    Overall Survival
    Erignisfreies Überleben
    Gesamtüberleben (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of the study, EFS and OS rate, will be evaluated
    confirmatory in comparison to the historical controls 24 months after last patient's inclusion into the study (estimated 2020).
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Rate of complete remission (CR), Relapse-free survival (RFS), Overall survival (OS)
    • Cumulative incidence of relapse (CIR) and death (CID) in CR
    • Target (FLT3) inhibition by measuring the FLT3 plasma inhibitory activity

    Safety Endpoints
    • Rate of early deaths and hypoplastic deaths (ED/HD)
    • Death in CR
    • Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 3.0), timing and relatedness of hematological and non-hematological toxicities observed during the different treatment cycles; maximally tolerated rates will be defined based on historical data of AMLSG

    QoL Endpoint
    Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics initially, in first CR, after one year, 3 and 5 years after initial diagnosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be analyzed at the same time point as the
    primary endpoint in an exploratory manner.
    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 concerned48
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    The whole study is terminated prematurely in case of fulfilled safety
    endpoints and the external review board as well as the internal review board agree to terminate the study. If new scientific results appear during the duration of the study rendering the continuation of the study questionable, the principal Investigator and the internal review board have to discuss and decide a premature termination of the study.
    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: 378
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state375
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 440
    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)
    After finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible hematologic-oncologic center.
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-26
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