ASC4START (CABL001J12302) = Asciminib versus nilotinib in patients with newly diagnosed CML [Asia-Pacific, Europe, Middle East, North America, South America]
Type of study
First line trial
Phase
Current status
Recruiting
Study title
A study to compare asciminib versus nilotinib in patients with newly diagnosed chronic myelogenous leukemia (CML)
Scientific title
A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Other trial ID
CABL001J12302; EudraCT no. 2022-000995-21; ClinicalTrials.gov NCT05456191
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
In this study, participants will be randomized into two groups and receive either oral asciminib 80 mg once daily or nilotinib 300 mg twice daily.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have been diagnosed with Philadelphia chronic myeloid leukemia in chronic phase (CML-CP) within 3 months of study entry
- have evidence of a typical BCR::ABL1 transcript [e14a2 and/or e13a2] that can be quantified on standardized real time polymerase chain reaction (RT-PCR) by the central laboratory
- have an Eastern Co-Operative Group (ECOG) status of 0 or 1.
Further criteria may apply. Please discuss these with your doctor or study staff.
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 sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Study centers / principal investigators
Argentina
Novartis Investigative Site
Buenos Aires, C1114AAN
Novartis Investigative Site
Buenos Aires, C1425AUM
Novartis Investigative Site
Buenos Aires, C1039AAC
Novartis Investigative Site
Caba, Buenos Aires, C1181ACH
Novartis Investigative Site
Caba, Buenos Aires, C1221ADH
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
Canada
Ontario
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
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
Augsburg, 86179
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
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erlangen, 91054
Universitätsklinikum Essen
Principal Investigator: PD Dr. Joachim Göthert
Essen, 45122
Novartis Investigative Site
Frankfurt, 60590
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
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Magdeburg, 39104
Universitätsmedizin Mannheim
III. Medizinische Klinik
Principal Investigator: Prof. Dr. Suanne Saussele
Mannheim, 68169
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 80377
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
Novartis Investigative Site
Würzburg, 97080
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
India
Novartis Investigative Site
Rishikesh, Uttarakhand, 249203
Italy
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Pisa, PI, 56126
Jordan
Novartis Investigative Site
Amman, 11941
Korea, Republic of
Novartis Investigative Site
Bundang Gu, Gyeonggi Do, 13620
Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759
Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Petaling Jaya, Selangor Darul Ehsan, 46150
Netherlands
Novartis Investigative Site
Dordrecht, 3318AT
Oman
Novartis Investigative Site
Muscat, 123
Romania
Novartis Investigative Site
Bucharest, 030 171
Novartis Investigative Site
Bucharest, District 2, 022328
Novartis Investigative Site
Bucuresti, 021494
Novartis Investigative Site
Cluj-Napoca, 400124
Novartis Investigative Site
Craiova, 200136
Novartis Investigative Site
Sibiu, 550245
Novartis Investigative Site
Timisoara, 300079
Novartis Investigative Site
Tg Mures, Mures, 540136
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
Switzerland
Novartis Investigative Site
Genève, 1211
United Kingdom
Novartis Investigative Site
Gloucester, GL1 3NN
Novartis Investigative Site
London, W12 0HS
United States
Texas
Lumi Research
Saleha Sajid
Kingwood, Texas, 77339