NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second or third TKI stop [Europe]
Study title
Efficacy of nilotinib in inducing persistence of molecular remission after second or third TKI stop
Scientific title
Multicenter prospective trial after first or second 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 or third time (ClinicalTrials.gov NCT02917720; EudraCT no. 2015-004998-33)
Type of study
Treatment discontinuation trial
Current status
No longer recruiting
What is the purpose of the study
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 attempt stopping 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.
Key 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 first or second 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.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
University of Heidelberg, Germany, with financial support from Novartis GmbH
Scientific lead / contact
Prof. Dr. Susanne Saußele
MCC-Studienzentrale, III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68167 Mannheim
Principal investigator
Prof. Dr. Susanne Saußele
MCC-Studienzentrale, III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68167 Mannheim
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
Freiburg
Universitätsklinikum Freiburg
Innere Medizin I
Prof. Dr. Cornelius Waller
Hugstetter Str. 55
79108 Freiburg
Halle (Saale)
Universitätsklinikum Halle
Universitätsklinik und Poliklinik für Innere Medizin IV
PD Dr. med. Haifa Kathrin Al-Ali
Ernst-Grube-Str. 40
06120 Halle (Saale)
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
Mannheim
MCC-Studienzentrale, III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
Prof. Dr. Susanne Saußele
68167 Mannheim
Marburg
Universitätsklinikum Gießen und Marburg,
Standort Marburg
Klinik für Hämatologie, Onkologie und Immunologi
Prof. Dr. med. Andreas Burchert
35043 Marburg
München
Klinikum rechts der Isar
Klinik und Poliklinik für innere Medizin III
Dr. med. Peter Herhaus
Ismaninger Str. 22
81675 München
Mutlangen
Klinikum Ostalb, Stauferklinikum Schwäbisch Gmünd
Zentrum für Innere Medizin
Prof. Dr. Holger Hebart
Wetzgauer Str. 85
73557 Mutlangen
Rostock
Universitätsmedizin Rostock
ZIM III – Hämatologie, Onkologie, Palliativmedizin
Prof. Dr. med. Christian Junghanß
Ernst-Heydemann-Straße 6
18057 Rostock
Villingen Schwenningen
Schwarzwald-Baar Klinikum
Klinik für Innere Medizin II
Prof. Dr. med. Paul Graf La Rosée
Klinikstraße 11
78052 Villingen-Schwenningen
The Netherlands
VU University Medical Center Amsterdam
Dr. Jeroen Janssen
1081 HV Amsterdam