Clinical trial • Phase III • Haematology

CYTARABINE, DAUNORUBICIN for Acute myeloid leukaemia (AML) | AML with myelodysplasia-related changes (AML-MRC) | Therapy-related acute myeloid leukaemia

Phase III trial of CYTARABINE, DAUNORUBICIN for Acute myeloid leukaemia (AML) | AML with myelodysplasia-related changes (AML-MRC) | Therapy-related acute…

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Acute myeloid leukaemia (AML) | AML with myelodysplasia-related changes (AML-MRC) | Therapy-related acute myeloid leukaemia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-01-2024
First CTIS Authorization Date
15-02-2024

Trial design

Randomised, daunorubicin (comparator) intravenous; max daily dose amount reported 60 mg/m2 (max total dose amount 330 mg/m2). cytarabine (comparator) intravenous; max daily dose amount reported 1500 mg/m2 (max total dose amount 17900 mg/m2). (schedule details not specified in the ctis record.)-controlled Phase III trial in Austria, Germany.

Randomised
Yes
Comparator
Daunorubicin (comparator) intravenous; max daily dose amount reported 60 mg/m2 (max total dose amount 330 mg/m2). Cytarabine (comparator) intravenous; max daily dose amount reported 1500 mg/m2 (max total dose amount 17900 mg/m2). (Schedule details not specified in the CTIS record.)
Target Sample Size
842

Eligibility

Recruits 842 No vulnerable population selected. Only adults (Age ≥ 18 years). Subjects must be able to understand and willing to sign an informed consent form (ICF); consent is provided by the participant. Consent for registration/storage/processing of disease characteristics and for biobanking is required (lack of such consent is an exclusion). No assent procedures for minors are described because minors are excluded..

Pregnancy Exclusion
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 randomization (“Women of childbearing potential” is defined as a sexually active mature woman who has not undergone a hysterectomy or bilateral oophorectomy or who has had menses at any time in the preceding 24 consecutive months)
Vulnerable Population
No vulnerable population selected. Only adults (Age ≥ 18 years). Subjects must be able to understand and willing to sign an informed consent form (ICF); consent is provided by the participant. Consent for registration/storage/processing of disease characteristics and for biobanking is required (lack of such consent is an exclusion). No assent procedures for minors are described because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria [Appendix B]), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification\n- Female patients of childbearing potential must agree to avoid getting pregnant while on therapy and for 27 weeks after the last dose of study drug\n- Women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or apply one highly effective method of birth control (such as IUD, bilateral tubal ligation, or partner’s vasectomy) in combination with one acceptable method of birth control at the same time (such as hormonal contraception or the male partner has to use a latex condom coated with spermicide lubricant or combined with spermicide gel or foam) while on therapy and for 27 weeks after the last dose of study drug. Hormonal contraception is only a highly effective method of birth control in case of combined (estrogen and progestogen containing) associated with inhibition of ovulation or progestogen-only hormonal contraception associated with inhibition of ovulation is used\n- Men must use a latex condom coated with a spermicide lubricant or combined with spermicide gel or foam 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 6 months after the last dose of study drug). In addition, their female partners of childbearing potential have to use a highly effective method of birth control\n- Able to understand and willing to sign an informed consent form (ICF)\n- Age ≥ 18 years, no upper age limit\n- Patient considered eligible for intensive chemotherapy\n- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening\n- Genetic assessment in AMLSG central laboratory\n- Adequate renal function as evidenced by serum creatinine ≤ 2.0 × ULN or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR)\n- Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless considered due to Gilbert’s disease, or leukemic involvement following approval by the Coordinating Investigator or Co-Coordinating Investigator; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Coordinating Investigator or Co-Coordinating Investigator\n- No prior chemotherapy for acute leukemia except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts >30x10^9/l); prior treatment of myelo-dysplastic syndrome with hypomethylating agents is allowed\n- 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 randomization (“Women of childbearing potential” is defined as a sexually active mature woman who has not undergone a hysterectomy or bilateral oophorectomy or who has had menses at any time in the preceding 24 consecutive months)"}

Exclusion criteria

  • {"criterion_text":"- AML with favorable-risk genetics according to 2017 ELN criteria [Appendix B]: - AML with t(8;21)(q22;q22.1), RUNX1-RUNX1T1; - AML with inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11; - AML with mutated NPM1 without FLT3-ITD or with FLT3-ITDlow; - AML with biallelic CEBPA mutation\n- Evidence of active hepatitis B or C infection or known Human Immunodeficiency Virus (HIV) infection\n- Patients with a “currently active” second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, subjects with the following history/concurrent conditions are allowed: - Basal or squamous cell carcinoma of the skin; - Carcinoma in situ of the cervix; -\tCarcinoma in situ of the breast, - Incidental histologic finding of prostate cancer\n- Severe neurological or psychiatric disorder interfering with ability to give an informed consent\n- No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation\n- No consent for biobanking of patient’s biological specimens\n- Current participation in any other interventional clinical trial within 30 days before the first administration of the investigational product or at any time during the trial\n- Patients with prior cumulative anthracycline exposure of daunorubicin (or equivalent) can be included but the maximum of daunorubicin (or equivalent) dose of 550 mg/m2 must not be exceeded. Anthracycline-based therapy should be avoided until exposure to the previous cardiotoxic agents is negligible. If this is not possible, the patient's cardiac function should be carefully monitored and an absolute cumulative dose of 400 mg/m² in adults can be exceeded only with great caution. In patients who received radiation therapy to the mediastinum the maximum of daunorubicin (or equivalent) dose of 400 mg/m2 must not be exceeded.\n- Known or suspected hypersensitivity to cytarabine, daunorubicin or liposomal products and/or any excipients\n- History of Wilson’s disease or other copper-metabolism disorder\n- Receipt of live, attenuated vaccine within 30 days prior to the inclusion in the clinical trial (NOTE: Subjects, if enrolled, should not receive live vaccine during the trial and until 6 months after the therapy).\n- AML with FLT3 mutation as assessed by DNA fragment analysis PCR for FLT3-ITD and FLT3-TKD mutation. Positivity is defined as a FLT3-ITD or FLT3-TKD / FLT3-WT ratio of ≥ 0.05 (5%).\n- Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA; or one of the other pathognomonic variant chromosomal translocations/ fusion genes\n- AML with BCR-ABL1\n- Prior treatment of myelodysplastic syndrome (MDS) with intensive chemotherapy or bone marrow transplant with a curative intent\n- Significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; myocardial infarction, unstable angina and/or stroke; severe cardiac arrhythmias, or left ventricular ejection fraction (LVEF) <50% by ultrasound obtained within 28 days prior to the start of study treatment\n- Severe obstructive or restrictive ventilation disorder\n- Uncontrolled infection\n- Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required, if there is a clinical suspicion of CNS involvement by leukemia during screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS) in the restricted set of de novo patients","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS) in the extended set of patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Event-free survival (EFS) with CRi considered as response to induction therapy in both, the restricted set of de novo patients and the extended set of patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Event-free survival (EFS) with CRi considered as failure of induction therapy in the restricted set of de novo patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Rate of objective responses (complete remission [CR], CR with incomplete hematologic recovery [CRi], CRi without measurable residual disease [CRiMRD-], CR without measurable residual disease [CRMRD-]) in the restricted set of de novo patients","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
842
Recruitment Window Months
92
Consent Approach
Informed consent must be signed by the participant (Able to understand and willing to sign an informed consent form (ICF)). Adults only (Age ≥ 18). Specific ICF and addendum documents are provided (documents listed include L1_ICF main and addendum; German-language ICFs are present). Consent for registration/storage/processing of disease characteristics and for biobanking is required (lack of such consent excludes participation). No assent for minors is described because minors are excluded.

Geography

Total Number Of Sites
63
Total Number Of Participants
842

Austria

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
16-05-2025
Processing Time Days
471
Number Of Sites
6
Number Of Participants
76

Sites

Site Name
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name
III. Medizinische Abteilung
Contact Person Name
Elisabeth Koller
Contact Person Email
elisabeth.koller@wgkk.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik für Innere Medizin III
Contact Person Name
Lisa Pleyer
Contact Person Email
l.pleyer@salk.at
Site Name
Tirol Kliniken GmbH
Department Name
Universitätsklinik für Innere Medizin V
Contact Person Name
David Nachbaur
Site Name
Ordensklinikum Linz GmbH
Department Name
Hämatologie/Onkologie
Contact Person Name
Sigrid Machherndl-Spandl
Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Interne E
Contact Person Name
Bernd Hartmann
Contact Person Email
bernd.hartmann@lkhf.at
Site Name
University Hospital Graz
Department Name
Klinische Abteilung für Hämatologie
Contact Person Name
Armin Zebisch
Contact Person Email
armin.zebisch@medunigraz.at

Germany

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
659
Number Of Sites
57
Number Of Participants
766

Sites

Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Fachabteilungsbereich Hämatologie und internistische Onkologie
Contact Person Name
Jan Schleicher
Site Name
Medical Center - University Of Freiburg
Department Name
Medizinische Universitätsklinik, Abteilung Medizin I
Principal Investigator Name
Michael Lübbert
Principal Investigator Email
michael.luebbert@uniklinik-freiburg.de
Contact Person Name
Michael Lübbert
Site Name
Marienhaus Klinikum St. Elisabeth Saarlouis
Department Name
Klinik für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin
Contact Person Name
Katharina Gräber
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Medizinische Klinik I
Principal Investigator Name
Maher Hanoun
Principal Investigator Email
Maher.Hanoun@gesundheitnord.de
Contact Person Name
Maher Hanoun
Contact Person Email
Maher.Hanoun@gesundheitnord.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin
Principal Investigator Name
Swen Wessendorf
Principal Investigator Email
s.wessendorf@klinikum-esslingen.de
Contact Person Name
Swen Wessendorf
Site Name
Medizinische Hochschule Hannover
Department Name
Zentrum Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantat
Principal Investigator Name
Felicitas Thol
Principal Investigator Email
thol.felicitas@mh-hannover.de
Contact Person Name
Felicitas Thol
Contact Person Email
thol.felicitas@mh-hannover.de
Site Name
Klinikum Oldenburg AöR
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Andreas Voß
Principal Investigator Email
voss.andreas@klinikum-oldenburg.de
Contact Person Name
Andreas Voß
Site Name
Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Volker Runde
Principal Investigator Email
volker.runde@kkle.de
Contact Person Name
Volker Runde
Contact Person Email
volker.runde@kkle.de
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Innere Medizin 1
Principal Investigator Name
Tobias Buss
Principal Investigator Email
tobias.buss@mutterhaus.de
Contact Person Name
Tobias Buss
Contact Person Email
tobias.buss@mutterhaus.de
Site Name
Evangelisches Krankenhaus Hamm gGmbH
Department Name
Medizinische Klinik, Abteilung Hämatologie-Onkologie
Principal Investigator Name
Alexander Baraniskin
Principal Investigator Email
alexander.baraniskin@valeo-kliniken.de
Contact Person Name
Alexander Baraniskin
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department für Innere Medizin, Innere Medizin II
Principal Investigator Name
Claudia Lengerke
Principal Investigator Email
Claudia.lengerke@med.uni-tuebingen.de
Contact Person Name
Claudia Lengerke
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
II. Medizinische Abteilung - Hämatologie und internistische Onkologie
Principal Investigator Name
Hans Salwender
Principal Investigator Email
h.salwender@asklepios.com
Contact Person Name
Hans Salwender
Contact Person Email
h.salwender@asklepios.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Zentrum für Innere Medizin, Medizinische Klinik III
Principal Investigator Name
Lino Teichmann
Principal Investigator Email
lino.teichmann@uni-bonn.de
Contact Person Name
Lino Teichmann
Contact Person Email
lino.teichmann@uni-bonn.de
Site Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Department Name
Innere Medizin II
Principal Investigator Name
Paul Graf La Rosèe
Principal Investigator Email
paul.larosee@sbk-vs.de
Contact Person Name
Paul Graf La Rosèe
Contact Person Email
paul.larosee@sbk-vs.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Zentrum für Innere Medizin, Medizinische Klinik IV
Principal Investigator Name
Tobias Arnold
Principal Investigator Email
tobias.arnold@uk-gm.de
Contact Person Name
Tobias Arnold
Contact Person Email
tobias.arnold@uk-gm.de
Site Name
Malteser Norddeutschland gGmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Nicolai Faber
Principal Investigator Email
nicolai.faber@malteser.org
Contact Person Name
Nicolai Faber
Contact Person Email
nicolai.faber@malteser.org
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Innere Medizin III
Principal Investigator Name
Verena Gaidzik
Principal Investigator Email
verena.gaidzik@uniklinik-ulm.de
Contact Person Name
Verena Gaidzik
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Principal Investigator Name
Jörg Westermann
Principal Investigator Email
joerg.westermann@charite.de
Contact Person Name
Jörg Westermann
Contact Person Email
joerg.westermann@charite.de
Site Name
Klinikum Darmstadt GmbH
Department Name
Medizinische Klinik V - Onkologie und Hämatologie
Principal Investigator Name
Helga Bernhard
Principal Investigator Email
helga.bernhard@klinikum-darmstadt.de
Contact Person Name
Helga Bernhard
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Universitätsklinik für Hämatologie und Onkologie
Principal Investigator Name
Martin Mikusko
Principal Investigator Email
martin.mikusko@med.ovgu.de
Contact Person Name
Martin Mikusko
Contact Person Email
martin.mikusko@med.ovgu.de
Site Name
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Department Name
Zentrum für Innere Medizin
Principal Investigator Name
Holger Hebart
Principal Investigator Email
holger.hebart@kliniken-ostalb.de
Contact Person Name
Holger Hebart
Site Name
Pius-Hospital Oldenburg
Department Name
Internistische Onkologie
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger
Site Name
Asklepios Klinik St George
Department Name
Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Ahmet Elmaagacli
Principal Investigator Email
a.elmaagacli@asklepios.com
Contact Person Name
Ahmet Elmaagacli
Contact Person Email
a.elmaagacli@asklepios.com
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Silke Schostok
Principal Investigator Email
silke.schostok@helios-kliniken.de
Contact Person Name
Silke Schostok
Site Name
Maerkische Kliniken GmbH
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Monika Schwalenberg
Contact Person Name
Monika Schwalenberg
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Medizinische Abteilung A
Principal Investigator Name
Peter Paschka
Principal Investigator Email
paschkap@klilu.de
Contact Person Name
Peter Paschka
Contact Person Email
paschkap@klilu.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Markus Lindauer
Principal Investigator Email
markus.lindauer@slk-kliniken.de
Contact Person Name
Markus Lindauer
Site Name
Charite Universitaetsmedizin Berlin KöR (Augustenburger Platz)
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Principal Investigator Name
Jörg Westermann
Principal Investigator Email
joerg.westermann@charite.de
Contact Person Name
Jörg Westermann
Contact Person Email
joerg.westermann@charite.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Abteilung für Hämatologie und Internistische Onkologie
Principal Investigator Name
Daniel Heudobler
Principal Investigator Email
Daniel.Heudobler@klinik.uni-regensburg.de
Contact Person Name
Daniel Heudobler
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Mark Ringhoffer
Principal Investigator Email
mark.ringhoffer@klinikum-karlsruhe.de
Contact Person Name
Mark Ringhoffer
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik für Innere Medizin C
Principal Investigator Name
Christian Späth
Principal Investigator Email
christian.spaeth@med.uni-greifswald.de
Contact Person Name
Christian Späth
Site Name
Augusta-Kranken-Anstalt gGmbH
Department Name
Klinik für Onkologie, Hämatologie und Palliativmedizin
Principal Investigator Name
Stefan Lukic
Principal Investigator Email
s.lukic@augusta-bochum.de
Contact Person Name
Stefan Lukic
Contact Person Email
s.lukic@augusta-bochum.de
Site Name
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Department Name
Zentrum für Innere Medizin - Hämatologie, internistische Onkologie u. Stammzelltransplantation
Principal Investigator Name
Stephanie von Harsdorf
Principal Investigator Email
s.vonHarsdorf@kem-med.com
Contact Person Name
Stephanie von Harsdorf
Contact Person Email
s.vonHarsdorf@kem-med.com
Site Name
Klinikum Passau
Department Name
II. Medizinische Klinik
Principal Investigator Name
Thomas Südhoff
Principal Investigator Email
Thomas.Suedhoff@klinikum-passau.de
Contact Person Name
Thomas Südhoff
Site Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name
Medizinische Klinik
Principal Investigator Name
Roland Schroers
Principal Investigator Email
roland.schroers@rub.de
Contact Person Name
Roland Schroers
Contact Person Email
roland.schroers@rub.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Hindenburgdamm)
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Principal Investigator Name
Jörg Westermann
Principal Investigator Email
joerg.westermann@charite.de
Contact Person Name
Jörg Westermann
Contact Person Email
joerg.westermann@charite.de
Site Name
Klinikum Lippe GmbH
Department Name
Medizinische Klinik II
Principal Investigator Name
Sarunas Bagdonas
Principal Investigator Email
sarunas.bagdonas@klinikum-lippe.de
Contact Person Name
Sarunas Bagdonas
Site Name
Klinikum Aschaffenburg-Alzenau gGmbH
Department Name
Hämatologie/Onkologie
Principal Investigator Name
Manfred Welslau
Principal Investigator Email
manfred.welslau@klinikum-ab-alz.de
Contact Person Name
Manfred Welslau
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
III. Medizinische Klinik
Principal Investigator Name
Katharina Götze
Principal Investigator Email
katharina.goetze@tum.de
Contact Person Name
Katharina Götze
Contact Person Email
katharina.goetze@tum.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Innere Medizin - Hämatologie und Onkologie
Principal Investigator Name
Maike de Wit
Principal Investigator Email
maike.dewit@vivantes.de
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik und Poliklinik
Principal Investigator Name
Michael Kühn
Principal Investigator Email
michael.kuehn@unimedizin-mainz.de
Contact Person Name
Michael Kühn
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Hämatologie/Onkologie
Principal Investigator Name
Friederike Wortmann
Principal Investigator Email
friederike.wortmann@uksh.de
Contact Person Name
Friederike Wortmann
Contact Person Email
friederike.wortmann@uksh.de
Site Name
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH
Department Name
Medizinische Klinik II
Principal Investigator Name
Jochen Greiner
Principal Investigator Email
greiner@diak-stuttgart.de
Contact Person Name
Jochen Greiner
Contact Person Email
greiner@diak-stuttgart.de
Site Name
Klinikum Region Hannover GmbH
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Kim Marienhagen
Principal Investigator Email
kim.marienhagen@krh.eu
Contact Person Name
Kim Marienhagen
Contact Person Email
kim.marienhagen@krh.eu
Site Name
Klinikum Hochsauerland GmbH
Department Name
Klinik für Hämatologie, Onkologie, Palliativmedizin, Stammzelltransplantation
Principal Investigator Name
Mohammad Wattad
Principal Investigator Email
m.wattad@klinikum-hochsauerland.de
Contact Person Name
Mohammad Wattad
Site Name
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
Department Name
Medizinische Klinik III
Principal Investigator Name
Dirk Strumberg
Principal Investigator Email
dirk.strumberg@marienhospital-herne.de
Contact Person Name
Dirk Strumberg
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH (Dieffenbachstrasse)
Department Name
Innere Medizin Hämatologie und Onkologie
Principal Investigator Name
Christian Scholz
Principal Investigator Email
christianw.scholz@vivantes.de
Contact Person Name
Christian Scholz
Contact Person Email
christianw.scholz@vivantes.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Principal Investigator Name
Franziska Westendorf
Principal Investigator Email
f.westendorf@uke.de
Contact Person Name
Franziska Westendorf
Contact Person Email
f.westendorf@uke.de
Site Name
Kliniken Suedostbayern AG
Department Name
Innere Medizin, Abteilung Hämato-Onkologie
Principal Investigator Name
Florian Zettl
Principal Investigator Email
florian.zettl@kliniken-sob.de
Contact Person Name
Florian Zettl
Contact Person Email
florian.zettl@kliniken-sob.de
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Abteilung Innere Medizin I
Principal Investigator Name
Iordanis Deligiannis
Principal Investigator Email
i.deligiannis@bbtgruppe.de
Contact Person Name
Iordanis Deligiannis
Contact Person Email
i.deligiannis@bbtgruppe.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Hämatologie, Onkologie und Klinische Immunologie
Principal Investigator Name
Ulrich Germing
Principal Investigator Email
germing@med.uni-duesseldorf.de
Contact Person Name
Ulrich Germing
Contact Person Email
germing@med.uni-duesseldorf.de
Site Name
St. Johannes Hospital Dortmund
Department Name
Kliniken für Innere Medizin II
Principal Investigator Name
Darina Kodzhabasheva
Principal Investigator Email
darina.kodzhabasheva@joho-dortmund.de
Contact Person Name
Darina Kodzhabasheva
Site Name
Ortenau Klinikum
Department Name
Hämatologie/Onkologie/Palliativmedizin
Principal Investigator Name
Carsten Schwänen
Principal Investigator Email
Carsten.Schwaenen@ortenau-klinikum.de
Contact Person Name
Carsten Schwänen
Site Name
Muhlenkreiskliniken AöR
Department Name
Zentrum für Innere Medizin
Principal Investigator Name
Kai Wille
Principal Investigator Email
kai.wille@muehlenkreiskliniken.de
Contact Person Name
Kai Wille
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Klinik für Innere III - Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Daniel Schöndube
Principal Investigator Email
daniel.schoendube@helios-gesundheit.de
Contact Person Name
Daniel Schöndube
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Jürgen Krauter
Principal Investigator Email
j.krauter@skbs.de
Contact Person Name
Jürgen Krauter
Contact Person Email
j.krauter@skbs.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Ulm AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Merative Germany GmbH","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Jazz Pharmaceuticals PLC","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Alcedis GmbH","duties_or_roles":"[{\"code\":\"1\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Protocol review for the sponsor\"},{\"code\":\"8\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"[{\"code\":\"11\"},{\"code\":\"12\"},{\"code\":\"13\"},{\"code\":\"5\"},{\"code\":\"6\"},{\"code\":\"8\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"National Center For Tumor Diseases (NCT) Heidelberg","duties_or_roles":"[{\"code\":\"10\"}]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Vyxeos Liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
Active Substance
CYTARABINE, DAUNORUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised (EU marketing authorisation EU/1/18/1308/001)
Maximum Dose
maxDailyDoseAmount 100 (unit reported as 'Other'); maxTotalDoseAmount 990
Investigational Product Name
CYTARABINE
Active Substance
CYTARABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
maxDailyDoseAmount 1500 mg/m2; maxTotalDoseAmount 17900 mg/m2
Investigational Product Name
DAUNORUBICIN
Active Substance
DAUNORUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
maxDailyDoseAmount 60 mg/m2; maxTotalDoseAmount 330 mg/m2
Combination Treatment
Yes

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