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NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second TKI stop [Europe]

Study title

Efficacy of nilotinib in inducing persistence of molecular remission after second TKI stop

Scientific title

Multicenter prospective trial after first unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping tyrosine kinase inhibitors a second time (EudraCT no. 2015-004998-332015-004998-33)

Indication and most important inclusion criteria

This study includes patients from 18 years of age with chronic myeloid leukemia (CML) who have had a molecular relapse after a prior attempt to stop therapy with a tyrosine kinase inhibitor (TKI) therapy and who have been treated for at least one year with any TKI after the first stop.

Short description of intervention

Patients will be treated with nilotinib 600 mg/day for at least two years. Patients who achieve deep molecular remission (MR4.5 or better) at the end of treatment can make a second attempt to stop TKI treatment.

The main objective of the study is to assess whether more patients maintain at least major molecular remission at 12 and 36 months after stopping TKI therapy.

Type of study

Treatment discontinuation trial

Current status

recruiting

Study sponsor

University of Heidelberg, Germany, with financial support from Novartis GmbH

Scientific lead / contact

Prof. Dr. Susanne Saußele
III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68169 Mannheim, Germany

Principal investigator

Prof. Dr. Susanne Saußele
III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68169 Mannheim, Germany

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Germany

Aachen
Universitätsklinikum der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Prof. Dr. med. Tim Henrik Brümmendorf
Pauwelsstr. 30
52074 Aachen

Aschaffenburg
Studienzentrum Aschaffenburg
Dr. med. Martine Klausmann
Elisenstr. 26
63739 Aschaffenburg

Bayreuth
Klinikum Bayreuth GmbH
Medizinische Klinik IV
PD Dr. med. Alexander Kiani
Preuschwitzer Str. 101
95445 Bayreuth

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für innere Medizin III
Dr. med. Mathias Hänel 
Flemmingstr. 2
09113 Chemnitz

Dresden
Onkozentrum Dresden
Dr. Göhler/Dörfler/Boldt
DM Steffen Dörfel
Leipziger Str. 118
01127 Dresden

Essen
Universitätsklinikum Essen
Klinik für Hämatologie
Dr. med. Joachim R. Göthert
Hufelandstr. 55 
45147 Essen

Esslingen
Onkologische Schwerpunktpraxis
Dr. med. Robert Eckert
Berliner Str. 4
73728 Esslingen

Frankfurt
Centrum für Hämatologie und Onkologie Bethanien
Prof. Dr. med. Hans Tesch
Im Prüfling 17-19
60389 Frankfurt

Freiburg
Universitätsklinikum Freiburg
Innere Medizin I
Prof. Dr. med. Nikolas von Bubnoff
Hugstetter Str. 55
79108 Freiburg

Hannover
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
PD Dr. med. Christian Könecke
Carl-Neuberg-Str. 1
30625 Hannover

Heilbronn
Schwerpunktpraxis Onkologie
Dr. med. Jolanta Dengler
Allee 40
74072 Heilbronn

Jena
Universitätsklinikum Jena, Klinik und Poliklinik für Innere Medizin II
Hämatologie/Onkologie/ Stammzelltransplantation
Prof. Dr. med. Andreas Hochhaus
Erlanger Allee 101
07740 Jena

Mannheim
Universitätsmedizin Mannheim
III. Med. Klinik Mannheim
Prof. Dr. med. Susanne Saußele
Pettenkoferstr. 22
68169 Mannheim

Marburg
Universitätsklinikum Gießen und Marburg,
Standort Marburg
Klinik für Hämatologie, Onkologie und Immunologi
Prof. Dr. med. Andreas Burchert
35043 Marburg

Munich
Klinikum rechts der Isar
Klinik und Poliklinik für innere Medizin III
PD Dr. med. Philipp Jost
Ismaninger Str. 22
81675 Munich


The Netherlands

VU University Medical Center Amsterdam
Dr. Jeroen Janssen
1081 HV Amsterdam