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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

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

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

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

The Netherlands

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