ASC4START (CABL001J12302) = Asciminib versus nilotinib in patients with newly diagnosed CML [Europe, Jordan, Republic of Korea, Singapore]

What is the purpose of the study

This is a study to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP).

What will happen during the study

Key inclusion criteria

Key exclusion criteria

This study does not include patients who:

• have been treated previously for CML with any other anti-cancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide.
• have known infiltration of the central nervous system (CNS) by malignant cells, as confirmed by cytopathology (a specialist diagnostic technique to examine cells)
• have impaired cardiac function or cardiac repolarization abnormality.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in the EU Clinical Trials Registry. This is a database hosted by the European Medicines Agency (EMA).

Study centers / principal investigators

Bulgaria

Novartis Investigative Site
Pleven, 5800

Novartis Investigative Site
Plovdiv, 4002

Novartis Investigative Site
Sofia, 1413

Novartis Investigative Site
Sofia, 1431

Novartis Investigative Site
Sofia, 1797

Novartis Investigative Site
Varna, 9010

Czechia

Novartis Investigative Site
Brno Bohunice, 625 00

Novartis Investigative Site
Praha 2, 128 20

Novartis Investigative Site
Plzen-Bory, 30599

Novartis Investigative Site
Praha 10, 100 34

France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Caen Cedex, 14033

Novartis Investigative Site
Clermont Ferrand, 63003

Novartis Investigative Site
Lille Cedex, 59037

Novartis Investigative Site
Lyon, 69373

Novartis Investigative Site
Marseille, 13273

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Nice Cedex, 06202

Novartis Investigative Site
Paris Cedex 10, 75475

Novartis Investigative Site
Poitiers, 86000

Novartis Investigative Site
Strasbourg, 67200

Novartis Investigative Site
Toulouse, 31059

Novartis Investigative Site
Vandoeuvre les Nancy cedex, 54511

Germany

Uniklinik RWTH Aachen
Medizinische Klinik IV
Principal Investigator: Prof. Dr. Tim Brümmendorf
Aachen, 52074

Novartis Investigative Site
Bad Saarow, 15526

Klinik für Onkologie und Hämatologie
Klinikum Bayreuth
Principal Investigator: Prof. Dr. Alexaner Kiani
Bayreuth, 95445

Novartis Investigative Site
Berlin, 13353

Universitätsklinikum Bonn
Medizinischen Klinik und Poliklinik III
Principal Investigator: Dr. med. Lino Teichmann
Bonn, 53105

Klinikum Bremen Mitte gGmbH
Principal Investigator: Dr. med. Matthias Bormann
Bremen, 28177

Klinikum Chemnitz GmbH
Principal Investigator: PD Dr. Mathias Hänel
Chemnitz, 09113

Universitätsklinikum Essen
Principal Investigator: PD Dr. Joachim Göthert
Essen, 45122

Novartis Investigative Site
Freiburg, 79106

Universitätsklinikum Halle (Saale)
Principal Investigator: Dr. med. Nadja Jäkel
Halle, 06120

Novartis Investigative Site
Hamburg, 20246

Praxis für Hämatologie und Onkologie
Principal Investigator: Dr. med. Eyck von der Heyde
Hannover, 30161

Universitätsklinikum Heidelberg
Principal Investigator: Dr. med. Tim Sauer
Heidelberg, 69120

Universitätsklinikum Jena
Klinikum für Innere Medizin II
Principal Investigator: Prof. Dr. Andreas Hochhaus
Jena, 07743

Universitätsklinikum Leipzig
Principal Investigator: Dr. med. Georg-Nikolaus Franke
Leipzig, 04103

Universitätsmedizin Mannheim
III. Medizinische Klinik
Principal Investigator: Prof. Dr. Suanne Saussele
Mannheim, 68169

Novartis Investigative Site
Magdeburg, 39104

Novartis Investigative Site
München, 81241

Brüderkrankenhaus St. Josef Paderborn
Principal Investigator: Dr. med. Tobias Gaska
Paderborn, 33098

Krankenhaus Barmherzige Brüder Regensburg
Principal Investigator: Dr. med. Michael Schenk
Regensburg, 93049

Universitätsklinikum Tübingen
Principal Investigator: Prof. Dr. Martin Möhle
Tübingen, 72076

Universitätsklinikum Ulm
Principal Investigator: PD Dr. Frank Stegelmann
Ulm, 89081

Gemeinschaftspraxis für Innere Medizin Hämatologie
Principal Investigator: Dr. med Arnd Nusch
Velbert, 42551

Greece

Novartis Investigative Site
Ioannina, 455 00

Novartis Investigative Site
Larissa, 411 10

Novartis Investigative Site
Thessaloniki, 570 10

Novartis Investigative Site
Athens, 115 27

Novartis Investigative Site
Patras, 265 00

Hungary

Novartis Investigative Site
Budapest, 1085

Novartis Investigative Site
Budapest, 1097

Novartis Investigative Site
Eger, 3300

Jordan

Novartis Investigative Site
Amman, 11941

Korea, Republic of

Novartis Investigative Site
Bundang Gu, Gyeonggi Do, 13620

Romania

Novartis Investigative Site
Bucharest, District 2, 022328

Novartis Investigative Site
Bucharest, 030 171

Novartis Investigative Site
Cluj-Napoca, 400124

Novartis Investigative Site
Craiova, 200136

Novartis Investigative Site
Sibiu, 550245

Novartis Investigative Site
Timisoara, 300079

Singapore

Novartis Investigative Site
Singapore, 119228

Novartis Investigative Site
Singapore, 169608

Novartis Investigative Site
Singapore, S308433

Slovakia

Novartis Investigative Site
Kosice, 040 66

Novartis Investigative Site
Bratislava, 85107