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    Summary
    EudraCT Number:2015-004066-28
    Sponsor's Protocol Code Number:AMLSG2415
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 number2015-004066-28
    A.3Full title of the trial
    A Phase II Study with a Safety Run-in Phase Evaluating Vosaroxin With Azacitidine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia and Intermediate/Adverse Genetic Risk or Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2) - AMLSG 24-15
    Studie mit einem Dosisfindungsteil gefolgt von einem Phase II-Teil zu Vosaroxin in Kombination mit Azacitidin bei Patienten mit akuter myeloischer Leukämie und intermediärem bzw. ungünstigem genetischem Risiko oder myelodysplastischen Syndrom mit Exzess von Blasten (MDS-EB-2) (AMLSG 24-15)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study with a Safety Run-in Phase Evaluating Vosaroxin With Azacitidine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia and Intermediate/Adverse Genetic Risk or Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2) - AMLSG 24-15
    Studie mit einem Dosisfindungsteil gefolgt von einem Phase II-Teil zu Vosaroxin in Kombination mit Azacitidin bei Patienten mit akuter myeloischer Leukämie und intermediärem bzw. ungünstigem genetischem Risiko oder myelodysplastischen Syndrom mit Exzess von Blasten (MDS-EB-2) (AMLSG 24-15)
    A.3.2Name or abbreviated title of the trial where available
    AMLSG 24-15
    A.4.1Sponsor's protocol code numberAMLSG2415
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03338348
    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 supportSUNESIS PHARMACEUTICALS, INC
    B.4.2CountryUnited States
    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 pointVerena Gaidzik
    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+4973150045707
    B.5.5Fax number+4973150045905
    B.5.6E-mailverena.gaidzik@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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzacitidine
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 No
    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/3/12/990
    D.3 Description of the IMP
    D.3.1Product nameVosaroxin
    D.3.2Product code not applicalbe
    D.3.4Pharmaceutical form Injection
    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 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 acute myeloid leukemia (WHO 2016) and intermediate or adverse genetic risk (according to 2017 ELN recommendations); or patients with myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)
    Patienten mit bestätigter Diagnose einer akuten myeloischen Leukämie (WHO 2016) und intermediärem oder ungünstigem genetischem Risiko (entsprechend den ELN Empfehlungen 2017); oder Patienten mit myelodysplastischem Syndrom mit Exzess von Blasten (MDS-EB-2)
    E.1.1.1Medical condition in easily understood language
    Patients with Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2)
    Patienten mit Neu diagnostizierte akute myeloische Leukämie oder myelodysplastisches Syndrom mit Exzess von Blasten (MDS-EB-2)
    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 activity of vosaroxin in combination with azacitidine on the rate of complete remission (CR) and CR with incomplete blood count recovery (CRi)

    Evaluation der Aktivität von Vosaroxin in Kombination mit Azacitidin im Hinblick auf die Rate an kompletter Remission (CR) und CR mit inkompletter Regeneration des Blutbilds (CRi)
    E.2.2Secondary objectives of the trial
    To conduct a pre-defined subgroup analysis in patients with complex karyotype to evaluate the activity of vosaroxin in combination with azacitidine on CR and CRi

    To evaluate the rate of CR and rate of combined CR/CRi and CR with negativity for minimal residual disease (CRMRD-)
    To analyze the duration of response (DOR)
    To evaluate event-free survival (EFS)
    To evaluate overall survival (OS)
    Durchführung einer vordefinierten Subgruppenanalyse bei Patienten mit komplexem Karyotyp zur Evaluation des Einflusses der Kombinationstherapie von Vosaroxin und Azacitidin auf die CR und CRi

    Evaluation der CR Rate sowie der kombinierten Rate von CR/CRi und CR mit Negativität für minimale Resterkrankung (CRMRD-)
    Analyse der Remissionsdauer (DOR)
    Evaluation des ereignisfreien Überlebens (EFS)
    Evaluation des Gesamtüberlebens (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with confirmed diagnosis of acute myeloid leukemia (WHO 2016) and intermediate or adverse genetic risk (according to 2017 ELN recommendations); or patients with myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)
    2. Patients ≥60 years of age
    3. No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis for up to 10 days during the diagnostic screening phase; patients may have received prior therapy for myelodysplastic syndrome different from hypomethylating agents
    4. ECOG performance status ≤2
    5. Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 3 month after the last dose of vosaroxin)
    6. 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).
    7. Female patients of reproductive age must agree to avoid getting pregnant while on therapy and for 3 months after the last dose of vosaroxin.
    8. 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.
    9. Willing to adhere to protocol specific requirements
    10. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
    Patienten mit bestätigter Diagnose einer akuten myeloischen Leukämie (WHO 2016) und intermediärem oder ungünstigem genetischem Risiko (entsprechend den ELN Empfehlungen 2017); oder Patienten mit myelodysplastischem Syndrom mit Exzess von Blasten (MDS-EB-2)
    2. Patienten ≥60 Jahre
    3. Keine vorangegangene Chemotherapie für die Leukämie außer Hydroxyurea zur Kontrolle der Hyperleukozytose für 10 Tage während der diagnostischen Screening Phase; Patienten dürfen eine frühere Therapie für das myelodysplastische Syndrom erhalten haben, jedoch keine hypomethylierenden Substanzen
    4. ECOG Status ≤2
    5. Männer müssen während jeglichen sexuellen Kontaktes mit Frauen im gebärfähigem Alter ein Latexkondom verwenden, auch wenn sie sich einer erfolgreichen Vasektomie unterzogen haben, und müssen zustimmen, kein Kind zu zeugen (während der Therapie und für drei Monate nach der letzten Gabe von Vosaroxin)
    6. Nicht schwangere und nicht stillende Frauen im gebärfähigen Alter müssen einen negativen Schwangerschaftstest haben (Serum oder Urin) mit einer Sensitivität von wenigstens 25 mIU/mL innerhalb von 72 Stunden vor Registrierung (Frauen im gebärfähigen Alter sind definiert als sexuell aktive Frauen, welche sich nicht einer Hysterektomie unterzogen haben oder welche innerhalb der letzten 24 Monate eine Menstruationsblutung hatten)
    7. Weibliche Patientinnen im reproduktiven Alter müssen zustimmen, eine Schwangerschaft zu vermeiden für die Zeitdauer der Therapie sowie für drei Monate nach der letzten Gabe von Vosaroxin
    8. Frauen im gebärfähigen Alter müssen zustimmen, von heterosexuellen Handlungen abstinent zu sein oder eine adäquate Verhütungsmethode einzuleiten (IUD, Tubenligatur, Vasektomie des Partners). Hormonelle Kontrazeption ist keine adäquate Verhütungsmethode.
    9. Fähigkeit, die protokollspezifischen Anforderungen zu erfüllen
    10. Unterschriebene Einverständniserklärung
    E.4Principal exclusion criteria
    1. Known or suspected hypersensitivity to the study drugs and/or any excipients
    2. Favorable genetics: t(15;17)(q22;q12), PML-RARA; t(8;21)(q22;q22), RUNX1-RUNX1T1; inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow
    3. Prior treatment for AML except hydroxyurea
    4. Prior treatment for MDS with hypomethylating agents
    5. ECOG performance status >2
    6. Patients who are not eligible for intensive chemotherapy
    7. Inadequate cardiac, hepatic and/or renal function at the Screening Visit defined as:
    • Ejection fraction <40% confirmed by echocardiography
    • Creatinine >1.5x upper normal serum level
    • Total bilirubin, AST or ALT >1.5 upper normal serum level
    8. Active central nervous system involvement
    9. Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk, such as:
    • Myocardial infarction, unstable angina within 3 months before screening
    • Heart failure NYHA III/IV
    • Severe obstructive or restrictive ventilation disorder
    • Uncontrolled infection
    10. Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
    11. Currently receiving a therapy not permitted during the study, as defined in Section 10.5.4
    12. 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.
    13. Known history of positive test for Hepatitis B surface Antigen (HBsAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
    14. Hematological disorder independent of leukemia
    15. 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
    16. No consent for biobanking
    17. Current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study
    18. Patients known or suspected of not being able to comply with this trial protocol
    19. Patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of vosaroxin
    20. Breast feeding women or women with a positive pregnancy test at Screening visit
    1. Bekannte oder beobachtete Überempfindlichkeit gegenüber den in dieser Studie verwendeten Medikamenten
    2. Günstige Genetik: t(15;17)(q22;q12), PML-RARA; t(8;21)(q22;q22), RUNX1-RUNX1T1; inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11; mutiertes NPM1 ohneFLT3-ITD oder mit FLT3-ITDlow
    3. Vorangegangene Therapie der AML außer Hydroxyurea
    4. Vorangegangene Therapie des MDS mit hypomethylierenden Substanzen
    5. ECOG Status >2
    6. Patienten, welche sich nicht für eine intensive Chemotherapie eignen
    7. Nicht adäquate kardiale, hepatische und/oder renale Funktion zum Zeitpunkt der Screening Visite, definiert als:
    • Ejektionsfraktion <40%, nachgewiesen mit Echokardiographie
    • Kreatinin >1.5x der oberen Norm des Serumspiegels
    • Gesamtbilirubin, AST oder ALT >1.5 der oberen Norm des Serumspiegels
    8. Aktive Beteiligung des zentralen Nervensystems
    9. Jede klinische signifikante, fortgeschrittene oder instabile Erkrankung oder Anamnese, welche mit den primären oder sekundären Variablen interferieren könnte oder den Patienten einem speziellen Risiko aussetzen könnte, wie:
    • Myokardinfarkt, instabile Angina innerhalb von 3 Monaten vor dem Screening
    • Herzinsuffizienz NYHA III/IV
    • Schwere obstruktive oder restriktive Ventilationsstörung
    • Unkontrollierte Infektion
    10. Schwere neurologische oder psychiatrische Störung, die das Verstehen und die freiwillige sowie selbständige Unterzeichnen der Einverständniserklärung einschränken oder unmöglich machen
    11. Aktuelle Therapie, welche während der Studienteilnahme nicht erlaubt ist; siehe Studienprotokoll Kapitel 10.5.4
    12. Patienten mit einer aktiven zweiten Neoplasie (Ausnahme: Hauttu-moren vom Nicht-Melanom-Typ). Patienten nach Abschluss der Therapie für die zweite Neoplasie und einer Rezidivwahrschein-lichkeit, die kleiner als 30 % ist, sind für das Protokoll geeignet. Die Rezidivwahrscheinlichkeit wird vom behandelnden Arzt eingeschätzt.
    13. Bekannte HIV Infektion; Hepatitis B oder Hepatitis C Infektion
    14. Hämatologische Grunderkrankung außerhalb der Leukämie
    15. Kein Einverständnis für die Registrierung, Lagerung und Handha-bung der personenbezogenen Krankheitsdaten und des Verlaufes sowie kein Einverständnis über die Information des Hausarztes und/oder anderer behandelnder Ärzte zur Studienteilnahme
    16. Kein Einverständnis für das Biobanking
    17. Aktive Teilnahme in einer anderen interventionellen klinischen Studie innerhalb von 30 Tagen vor der ersten Gabe der Prüfsubstanz oder zu jeder anderen Zeit während der Studie
    18. Patienten, welche sicher oder vermutlich keine Compliance gegenüber dem Studienprotokoll aufzeigen
    19. Patienten im zeugungsfähigen Alter, welche während der Therapie und drei Monate nach Gabe von Vosaroxin, eine adäquate Verhütung verweigern
    20. Stillende Frauen oder Frauen mit einem positiven Schwangerschaftstest zum Zeitpunkt der Screening-Visite
    E.5 End points
    E.5.1Primary end point(s)
    Rate of complete remission (CR) and CR with incomplete blood count recovery (CRi) after combined therapy with vosaroxin and azacitidine
    Rate der kompletten Remission (CR) und CR mit inkompletter Erholung des Blutbilds (CRi) nach kombinierter Therapie mit Vosaroxin und Azacitidin
    E.5.1.1Timepoint(s) of evaluation of this end point
    Simon’s optimal two stage design [32] will be used to evaluate the activity of the combined treatment with vosaroxin and azacitidine in older (≥60 years) patients with newly diagnosed AML or MDS-EB-2, who are unlikely to benefit from standard intensive chemotherapy. This will be evaluated after last Patient last vist.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    •CR and CRi in a pre-defined subgroup analysis in patients with complex karyotype after combined therapy with vosaroxin and azacitidine
    •CR and rate of combined CR/CRi and CR with negativity for minimal residual disease (CRMRD-)
    •Duration of response (DOR)
    •Event-free survival (EFS)
    •Overall survival (OS)


    Safety Endpoints
    •To determine safety and feasibility of the combination of vosaroxin with azacitidine
    •30-day and 60-day mortality
    •Incidence and intensity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version v4.0


    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 [22] at the Screening visit, after each treatment cycle, at the end of treatment visit and at the last follow-up visit
    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 concerned25
    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
    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 years4
    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 years4
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state168
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    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 Decision2018-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-10-31
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