FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI) [Germany]
Study title
FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI)
Scientific title
Frontline Asciminib Combination in Chronic Phase CML (ClinicalTrials.gov NCT03906292, EudraCT 2018‐002256‐33)
Type of study
First line trial
Current status
No longer recruiting
What is the purpose of the study
Within 3 months of diagnosis, patients will be treated initially for 12 weeks with standard of care. If this is well tolerated, standard of care will be combined with asciminib at different doses (60 mg once daily, 20 mg twice daily, 40 mg twice daily or 80 mg once daily). The aim is to improve quality of life and treatment adherence.
Key inclusion criteria
This study includes male or female patients who:
– are at least 18 years old
– have been diagnosed with Philadelphia chromosome positive (Ph+) and/or BCR-ABL1 positive chronic myeloid leukemia (CML) in chronic phase (CP) within 3 months of study entry
– have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
– Pretreatment is allowed with hydroxyurea for up to 4 weeks or with nilotinib 300 mg twice daily, imatinib 400 mg once daily or dasatinib 100 mg once daily for up to 6 weeks. Patients without any treatment for CML within 6 weeks of screening are also eligible for recruitment.
Other criteria may apply.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Thomas Ernst, PD Dr. med.
University of Jena
in collaboration with:
Ludwig-Maximilians – University of Munich
Novartis Pharmaceuticals
Scientific lead / contact
Thomas Ernst, PD Dr. med.
University of Jena
Principal investigator
Thomas Ernst, PD Dr. med.
University of Jena
Study centers / principal investigators
Germany
Universitätsklinikum Aachen Medizinische Klinik IV
Dr. med. Martina Crysandt
52074 Aachen
Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln
Prof. Dr. Maike de Wit
12351 Berlin
Charite Universitätsmeditin Berlin
Campus Virchow Klinikum
Prof. Dr. Philipp le Coutre
13353 Berlin
Universitätsklinikum Bonn
Dr. med. Lino Teichmann
53105 Bonn
Klinikum Bremen Mitte gGmbH
Dr. med. Matthias Bormann
28177 Bremen
Klinikum Chemnitz GmbH
PD Dr. Mathias Hänel
09113 Chemnitz
GOKOS GmbH
PD Dr. med. Thomas Illmer
01307 Dresden
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dr. med. Franziska Taube
01307Dresden
Universitätsklinikum Erlangen
Prof. Dr. Stefan Krause
91054 Erlangen
St.-Antonius-Hospital Eschweiler
PD Dr. Peter Staib
52249 Eschweiler
Universitätsklinikum Essen
PD Dr. Joachim Göthert
45122 Essen
Universitätsklinikum Frankfurt
Dr. med .Fabian Lang
60590 Frankfurt
Universitätsklinikum Freiburg
Prof. Dr. Cornelius Waller
79106 Freiburg
Universitätsklinikum Jena
PD Dr. Thomas Ernst
07747 Jena
Universitätsklinikum Leipzig
Dr. med. Georg-Nikolaus Franke
04103 Leipzig
Gemeinschaftspraxis
Dres. Müller, Kröning, Jentsch-Ullrich, Tietze, Krogel
Prof. Dr. Kathleen Jentsch-Ullrich
39104 Magdeburg
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Prof. Dr. Markus Radsak
55131 Mainz
Universitätsmedizin Mannheim
Prof. Dr. Susanne Saußele
68169 Mannheim
Universitätsklinikum Gießen und Marburg GmbH
Prof. Dr. Andreas Burchert
35043 Marburg
Klinikum rechts der Isar
Dr. med. Peter Herhaus
81675 München
Brüderkrankenhaus St. Josef Paderborn
Dr. med. Tobias Gaska
33098 Paderborn
Krankenhaus Barmherzige Brüder Regensburg
Dr. med. Michael Schenk
93049 Regensburg
Universitätsklinikum Ulm
PD Dr. Frank Stegelmann
89081 Ulm