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Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia (AML)

Intervention: Cytarabine (Drug); Etoposide (Drug); All-trans retinoic acid (ATRA) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Richard F Schlenk, MD, Principal Investigator, Affiliation: University Hospital of Ulm

Overall contact:
Peter Paschka, MD, Phone: 004973150045757, Email: peter.paschka@uniklinik-ulm.de


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)

Clinical Details

Official title: Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: overall survival

Secondary outcome:

Rate of Complete remission

cumulative incidence of relapse

cumulative incidence of death in complete remission

event-free survival

Rate of early deaths (ED)/hypoplastic deaths (HD)

Type, frequency, severity, timing and relatedness of adverse events (AEs) and laboratory abnormalities observed during different treatment cycles

Incidence of infection after each treatment cycle

Duration of neutropenia after each treatment cycle

Duration of thrombocytopenia after each treatment cycle

Duration of hospitalization after each treatment cycle

Quality of life


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


- 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.

Locations and Contacts

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

Additional Information

Starting date: March 2011
Last updated: October 14, 2014

Page last updated: August 23, 2015

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