This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients
with AML and NPM1 mutation ineligible for intensive chemotherapy.
Sample size: 144 patients
Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are
expected to be included into the trial)
Estimated treatment duration of an individual patient: 8 months (Follow-Up period per
patient will last additional 2 years)
Minimum age: 61 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Patients with confirmed diagnosis of acute myeloid leukemia according to the World
Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
- Presence of NPM1 mutation as assessed in one of the central AMLSG reference
laboratories.
- Age > 60 years. There is no upper age limit.
- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if
needed for up to 10 days during the diagnostic screening phase.
- Signed written informed consent
- Men must give their informed consent that they do not father a baby and 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 3 month after
the last dose of chemotherapy)
- WHO performance status ≤ 3
- Patients not eligible for intensive chemotherapy according to at least one of the
following criteria
- HCT-CI Score >2
- Patient's decision
- age ≥ 75 years
Exclusion Criteria:
The presence of any of the following will exclude a patient from study enrollment:
- All other AML subtypes, in particular those AML with other recurrent genetic changes
(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 other translocations involving RARA)
- AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
- AML with t(6;9)(p23;q34); DEK-NUP214
- AML with inv(3)(q21q26. 2) or t(3;3)(q21;q26. 2); RPN1-EVI1
- No consent for registration, storage and processing of the individual
disease-characteristics and course as well as information of the family physician and
all other treating physicians about study participation
- Bleeding disorder independent of leukemia
- Uncontrolled infection
- Known positive for HIV, HBV or HCV
- 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)
- 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.
Peter Paschka, MD, Phone: 004973150045757, Email: peter.paschka@uniklinik-ulm.de
Ubbo-Emmius Klinik Aurich, Aurich 26603, Germany; Recruiting
Dietmar Reichert, MD
Dietmar Reichert, MD, Principal Investigator
Charité Universitätsmedizin Berlin, Berlin 13353, Germany; Recruiting
Joerg Westermann, MD, Phone: 004930450553192, Email: joerg.westermann@charite.de
Joerg Westermann, MD, Principal Investigator
University Hospital of Bonn, Bonn 53111, Germany; Recruiting
Marie von Lilienfeld-Toal, MD, Phone: 014922828714003, Email: m.lilienfeld.toal@uni-bonn.de
Marie von Lilienfeld-Toal, MD, Principal Investigator
Annkristin Heine, MD, Sub-Investigator
Städtisches Klinikum Braunschweig, Braunschweig 38114, Germany; Recruiting
Jens Karsten
Jens Karsten, Principal Investigator
Klinikum Bremen-Mitte gGmbH, Bremen 28177, Germany; Recruiting
Bernd Hertenstein, MD, Phone: 0049 421-497-5240, Email: bernd.hertenstein@klinikum-bremen-mitte.de
Bernd Hertenstein, MD, Principal Investigator
Kliniken Essen Süd, Evangelischs Krankenhaus, Essen 45239, Germany; Recruiting
Peter Reimer, MD, Principal Investigator
Klinikum Esslingen, Esslingen 73730, Germany; Recruiting
Carsten Schwaenen, MD, Phone: +497113103-82460, Email: c.schwaenen@klinikum-esslingen.de
Carsten Schwaenen, MD, Principal Investigator
Medizinische Universitätsklinik, Freiburg 79106, Germany; Recruiting
Michael Luebbert, MD, Phone: 0049 761-270-3534, Email: Michael.luebbert@uniklinik-freiburg.de
Michael Luebbert, MD, Principal Investigator
Medizinisches Versorgungszentrum Osthessen GmbH, Fulda 36043, Germany; Recruiting
Heinz-Gert Höffkes, MD, Phone: 0049 661 84-5481, Email: hoeffkes.tumorklinik@klinikum-fulda.de
Heinz-Gert Höffkes, MD, Principal Investigator
Universitätsklinikum Gießen, Gießen 35392, Germany; Recruiting
Alexander Burchardt, MD, Principal Investigator
Wilhelm- Anton- Hospital gGmbH, Goch 47574, Germany; Recruiting
Volker Runde, MD, Phone: 0049 2823-891-115, Email: innere@wilhelm-anton-hospital-goch.de
Volker Runde, MD, Principal Investigator
Universitätsmedizin Göttingen, Göttingen 37075, Germany; Recruiting
Gerald Wulf, MD, Phone: 0049 551-39 12881, Email: gwulf@med.uni-goettingen.de
Gerald Wulf, MD, Principal Investigator
Asklepios Klinik Altona, Hamburg 22763, Germany; Recruiting
Hans-Jürgen Salwender, MD, Phone: +4940-8822-1212, Email: h.salwender@asklepios.com
Hans-Jürgen Salwender, MD, Principal Investigator
University Hospital of Hamburg Eppendorf, Hamburg 20246, Germany; Recruiting
Walter Fieder, Prof., Phone: 004940428033919, Email: fiedler@uke.uni-hamburg.de
Walter Fiedler, MD, Principal Investigator
Stefan Balabanov, MD, Sub-Investigator
Medical Department III, Hospital of Hannover-Siloah, Hannover 30449, Germany; Recruiting
Hartmut Kirchner, PD Dr., Phone: 0049-511-927-, Ext: 2801, Email: Hartmut.Kirchner.Siloah@krh.eu
Hartmut Kirchner, PD Dr., Principal Investigator
Medizinische Hochschule Hannover, Hannover 30625, Germany; Recruiting
Juergen Krauter, MD, Phone: 0049 511-532-3720, Email: krauter.juergen@mh-hannover.de
Juergen Krauter, MD, Principal Investigator
SLK-Kliniken Heilbronn GmbH, Heilbronn 74078, Germany; Recruiting
Uwe Martens, MD, Phone: 07131-49-2801, Email: uwe.martens@slk-kliniken.de
Uwe Martens, MD, Principal Investigator
Department of Internal Medicine I, University Hospital of Saarland, Homburg 66421, Germany; Recruiting
Michael Pfreundschuh, Prof. Dr., Phone: +49 (0) 6841-162-3084, Ext: 3031, Email: michael.pfreundschuh@uniklinik-saarland.de
Michael Pfreundschuh, Prof. Dr., Principal Investigator
Staedtisches Klinikum Karlsruhe, Karlsruhe 76133, Germany; Recruiting
Martin Bentz, MD, Phone: 0049 721-974-3000, Email: Martin.Bentz@klinikum-karlsruhe.com
Martin Bentz, MD, Principal Investigator
Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach, Lebach 66822, Germany; Recruiting
Stephan Kremers, Dr., Phone: +49 (0)6881-501-217, Email: s.kremers@caritas-krankenhaus-lebach.de
Stephan Kremers, Dr., Principal Investigator
Klinikum der Johannes Gutenberg Universität Mainz, Mainz 55131, Germany; Recruiting
Thomas Kindler, MD, Principal Investigator
Klinikum rechts der Isar der TU Muenchen, Muenchen 81675, Germany; Recruiting
Katharina Goetze, MD, Phone: 0049 89-4140-5814, Email: K.Goetze@lrz.tum.de
Katharina Goetze, MD, Principal Investigator
Stauferklinikum Schwäbisch Gmünd, Mutlangen 73557, Germany; Recruiting
Wolfgang Grimminger, MD, Principal Investigator
Pius Hospital Oldenburg, Oldenburg 26133, Germany; Recruiting
Frank Griesinger, MD
Astrid Schloen, MD, Principal Investigator
Krankenhaus der Barmherzigen Brueder, Regensburg 93049, Germany; Recruiting
Michael Schenk, MD, Phone: 0049 941 3632156
Michael Schenk, MD, Principal Investigator
Caritas-Klinik St. Theresia, Saarbrücken 66113, Germany; Recruiting
Axel Matzdorff, MD, Email: a.matzdorff@caritasklinik.de
Axel Matzdorff, MD, Principal Investigator
Clinikal Cetner of Stuttgart, Center of Oncology, Stuttgart 70174, Germany; Recruiting
Hans-Günther Mergenthaler, Prof. Dr., Phone: +49 (0) 711-278-5601, Ext: 5609, Email: h.mergenthaler@katharinenhospital.de
Hans-Günther Mergenthaler, Prof. Dr., Principal Investigator
Diakonie-Klinikum Stuttgart, Stuttgart 70176, Germany; Recruiting
Else Heidemann, MD, Phone: 0049 711-991-0 / 3501, Email: heidemann@diak-stuttgart.de
Else Heidemann, MD, Principal Investigator
Krankenhaus der Barmherzigen Brüder Trier, Trier 54292, Germany; Recruiting
Heinz Kirchen, MD, Email: h.kirchen@bk-trier.de
Heinz Kirchen, MD, Principal Investigator
Universitätsklinikum Tübingen, Tübingen 72076, Germany; Recruiting
Helmut Salih, MD, Principal Investigator
University hospital of Ulm, Ulm 89081, Germany; Recruiting
Richard F Schlenk, MD
Richard F Schlenk, MD, Principal Investigator
Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen, Villingen - Schwenningen 78050, Germany; Recruiting
Wolfram Brugger, Prof. Dr., Phone: +49 (0) 7721-93-4001, Ext: 4099, Email: imo.wolfram.brugger@klinikumvs.de
Wolfram Brugger, Prof. Dr., Principal Investigator
Helios Klinikum Wuppertal, Wuppertal 42283, Germany; Recruiting
Katrin Beckmann, MD
Katrin Beckmann, MD, Principal Investigator