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)

Indication and most important 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) with 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 or imatinib 400 mg once daily or dasatinib 100 mg once daily for up to 6 weeks.

Other criteria may apply.

Short description of intervention

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.

Type of study

First line trial

Current status

Recruiting

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

Additional information

Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health

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
Prof. Dr. Rainer Ordemann,
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
PD Dr. med. 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