ASC4START (CABL001J12302) = Asciminib versus nilotinib in patients with newly diagnosed CML [Asia-Pacific, Africa, Europe, Middle East, North America, South America]
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
Type of study
First line trial
Phase
Current status
Active, not recruiting
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 – active, not recruiting
Buenos Aires, C1114AAN
Novartis Investigative Site – active, not recruiting
Buenos Aires, C1425AUM
Novartis Investigative Site – active, not recruiting
Buenos Aires, C1039AAC
Novartis Investigative Site – active, not recruiting
Caba, Buenos Aires, C1181ACH
Novartis Investigative Site – active, not recruiting
Caba, Buenos Aires, C1221ADH
Bulgaria
Novartis Investigative Site – recruiting
Pleven, 5800
Novartis Investigative Site – recruiting
Plovdiv, 4002
Novartis Investigative Site – recruiting
Sofia, 1413
Novartis Investigative Site – withdrawn
Sofia, 1431
Novartis Investigative Site – recruiting
Sofia, 1797
Novartis Investigative Site – recruiting
Varna, 9010
Canada
Ontario
Novartis Investigative Site – active, not recruiting
London, Ontario, N6A 4G4
Novartis Investigative Site – active, not recruiting
Toronto, Ontario, M5G 2M9
Czechia
Novartis Investigative Site – active, not recruiting
Brno Bohunice, 625 00
Novartis Investigative Site – active, not recruiting
Praha 2, 128 20
Novartis Investigative Site – active, not recruiting
Plzen-Bory, 30599
Novartis Investigative Site – active, not recruiting
Praha 10, 100 34
France
Novartis Investigative Site – active, not recruiting
Bordeaux, 33076
Novartis Investigative Site – active, not recruiting
Caen Cedex, 14033
Novartis Investigative Site – active, not recruiting
Clermont Ferrand, 63003
Novartis Investigative Site – active, not recruiting
Lille, 59037
Novartis Investigative Site – active, not recruiting
Lyon, 69373
Novartis Investigative Site – active, not recruiting
Marseille, 13273
Novartis Investigative Site – active, not recruiting
Nantes Cedex 1, 44093
Novartis Investigative Site – active, not recruiting
Nice, 06202
Novartis Investigative Site – active, not recruiting
Paris 10, 75475
Novartis Investigative Site – active, not recruiting
Poitiers, 86000
Novartis Investigative Site – active, not recruiting
Strasbourg, 67200
Novartis Investigative Site – active, not recruiting
Toulouse, 31059
Novartis Investigative Site – active, not recruiting
Vandoeuvre les Nancy cedex, 54511
Germany
Uniklinik RWTH Aachen – active, not recruiting
Medizinische Klinik IV
Aachen, 52074
Novartis Investigative Site – active, not recruiting
Augsburg, 86179
Novartis Investigative Site – active, not recruiting
Bad Saarow, 15526
Klinik für Onkologie und Hämatologie – active, not recruiting
Klinikum Bayreuth
Bayreuth, 95445
Novartis Investigative Site – active, not recruiting
Berlin, 13353
Universitätsklinikum Bonn – active, not recruiting
Medizinischen Klinik und Poliklinik III
Bonn, 53105
Klinikum Bremen Mitte gGmbH – active, not recruiting
Bremen, 28177
Klinikum Chemnitz GmbH – active, not recruiting
Chemnitz, 09113
Novartis Investigative Site – active, not recruiting
Dresden, 01307
Novartis Investigative Site – active, not recruiting
Erlangen, 91054
Universitätsklinikum Essen – active, not recruiting
Essen, 45122
Novartis Investigative Site – active, not recruiting
Frankfurt, 60590
Novartis Investigative Site – active, not recruiting
Freiburg, 79106
Universitätsklinikum Halle (Saale) – active, not recruiting
Halle, 06120
Novartis Investigative Site – active, not recruiting
Hamburg, 20246
Praxis für Hämatologie und Onkologie – active, not recruiting
Hannover, 30161
Universitätsklinikum Heidelberg – active, not recruiting
Heidelberg, 69120
Universitätsklinikum Jena – active, not recruiting
Klinikum für Innere Medizin II
Jena, 07743
Universitätsklinikum Leipzig – active, not recruiting
Leipzig, 04103
Novartis Investigative Site – active, not recruiting
Lübeck, 23538
Novartis Investigative Site – active, not recruiting
Magdeburg, 39104
Novartis Investigative Site – active, not recruiting
Mannheim, 68305
Novartis Investigative Site – active, not recruiting
Marburg, 35039
Novartis Investigative Site – active, not recruiting
München, 80377
Novartis Investigative Site – active, not recruiting
München, 80241
Brüderkrankenhaus St. Josef Paderborn – active, not recruiting
Paderborn, 33098
Krankenhaus Barmherzige Brüder Regensburg – active, not recruiting
Regensburg, 93049
Universitätsklinikum Tübingen – active, not recruiting
Tübingen, 72076
Universitätsklinikum Ulm – active, not recruiting
Ulm, 89081
Gemeinschaftspraxis für Innere Medizin Hämatologie – active, not recruiting
Velbert, 42551
Novartis Investigative Site – active, not recruiting
Würzburg, 97080
Greece
Novartis Investigative Site – active, not recruiting
Athens, 106 76
Novartis Investigative Site – active, not recruiting
Athens, 115 27
Novartis Investigative Site – active, not recruiting
Ioannina, 455 00
Novartis Investigative Site – withdrawn
Larissa, 411 10
Novartis Investigative Site – active, not recruiting
Thessaloniki, 570 10
Novartis Investigative Site – active, not recruiting
Patras, 265 00
Hungary
Novartis Investigative Site – active, not recruiting
Budapest, 1085
Novartis Investigative Site – active, not recruiting
Budapest, 1097
Novartis Investigative Site – active, not recruiting
Eger, 3300
India
Novartis Investigative Site – active, not recruiting
New Delhi, 110029
India, Gujrat
Novartis Investigative Site – active, not recruiting
Ahmedabad, Gujrat, 380009
India, Tamilnadu
Novartis Investigative Site – active, not recruiting
Chennai, Tamilnadu, India, 600036
India, Uttar Pradesh
Novartis Investigative Site – active, not recruiting
Varanasi, Uttar Pradesh, 221010
India, Uttarakhand
Novartis Investigative Site – active, not recruiting
Rishikesh, Uttarakhand, 249203
Italy
Novartis Investigative Site – withdrawn
Bari, BA, 70124
Novartis Investigative Site – recruiting
Meldola, FC, 47014
Novartis Investigative Site – active, not recruiting
Milano, MI, 20162
Novartis Investigative Site – active, not recruiting
Pisa, PI, 56126
Novartis Investigative Site – active, not recruiting
Roma, RM, 00144
Novartis Investigative Site – active, not recruiting
Torino, TO, 10126
Jordan
Novartis Investigative Site – active, not recruiting
Amman, 11941
Korea, Republic of
Novartis Investigative Site – active, not recruiting
Bundang Gu, Gyeonggi Do, 13620
Novartis Investigative Site – active, not recruiting
Uijeongbu si, Gyeonggi Do, 11759
Malaysia
Novartis Investigative Site – active, not recruiting
Kuala Lumpur, 59100
Novartis Investigative Site – withdrawn
Penang, 10050
Malaysia, Kedah
Novartis Investigative Site – active, not recruiting
Alor Setar, Kedah, 05460
Malaysia, Sarawak
Novartis Investigative Site – active, not recruiting
Kuching, Sarawak, 93586
Malaysia, Selangor Darul Ehsan
Novartis Investigative Site – active, not recruiting
Petaling Jaya, Selangor Darul Ehsan, 46150
Netherlands
Novartis Investigative Site – active, not recruiting
Dordrecht, 3318AT
Oman
Novartis Investigative Site – active, not recruiting
Muscat, 123
Romania
Novartis Investigative Site – active, not recruiting
Bucharest, 030 171
Novartis Investigative Site – active, not recruiting
Bucharest, District 2, 022328
Novartis Investigative Site – active, not recruiting
Bucuresti, 021494
Novartis Investigative Site – active, not recruiting
Cluj-Napoca, 400124
Novartis Investigative Site – active, not recruiting
Craiova, 200136
Novartis Investigative Site – recruiting
Sibiu, 550245
Novartis Investigative Site – active, not recruiting
Timisoara, 300079
Novartis Investigative Site – active, not recruiting
Tg Mures, Mures, 540136
Singapore
Novartis Investigative Site – active, not recruiting
Singapore, 119228
Novartis Investigative Site – active, not recruiting
Singapore, 169608
Novartis Investigative Site – active, not recruiting
Singapore, S308433
Slovakia
Novartis Investigative Site – withdrawn
Kosice, 040 66
Novartis Investigative Site – active, not recruiting
Bratislava, 85107
South Africa
Novartis Investigative Site – active, not recruiting
Pretoria, 0044
South Africa, Gauteng
Novartis Investigative Site – active, not recruiting
Soweto, Gauteng, 2013
Switzerland
Novartis Investigative Site – active, not recruiting
Genève, 1211
Turkey
Novartis Investigative Site – active, not recruiting
Ankara, 06100
Novartis Investigative Site – active, not recruiting
Izmir, 35040
Novartis Investigative Site – active, not recruiting
Istanbul, 34098
United Arab Emirates
Novartis Investigative Site – active, not recruiting
Abu Dhabi, United Arab Emirates
United Kingdom
Novartis Investigative Site – active, not recruiting
Glasgow, G12 0YN
Novartis Investigative Site – active, not recruiting
Gloucester, GL1 3NN
Novartis Investigative Site – active, not recruiting
Gwent, NP9 2UB
Novartis Investigative Site – active, not recruiting
London, SE5 9RS
Novartis Investigative Site – active, not recruiting
London, W12 0HS
Novartis Investigative Site – recruiting
Truro, Cornwall, TR1 3LJ
United States
Arizona
Arizona Oncology Associates – recruiting
Principal Investigator: Alan Langerak
Phoenix, Arizona, 85016
California
Kaiser Permanente California South Kaiser – Irvine – recruiting
Principal Investigator: Ashraf Aziz
San Diego, California, 92120
Colorado
Rocky Mountain Cancer Centers USOR – active, not recruiting
Boulder, Colorado, 80304
Florida
Florida Cancer Specialists Dept. of Concology – recruiting
Principal Investigator: Adewale Alade Fawole
Fort Myers, Florida, 33901
Florida Cancer Specialists Pan – recruiting
Principal Investigator: Jeffrey Bubis
Tallahassee, Florida, 32308
Illinois
Illinois Cancer Center – recruiting
Principal Investigator: Srinivas Jujjararapu
Peoria, Illinois, 61615
Louisiana
Hematology and Oncology Clinic – recruiting
Principal Investigator: Michael Castine III
Baton Rouge, Louisiana, 70809
Minnesota
Minnesota Oncology Hematology P A Minnesota Oncology Hematology – recruiting
Principal Investigator: Danielle Tippit
Minneapolis, Minnesota, 55404
Regions Hospital Oncology Research Consortium – active, not recruiting
Saint Paul, Minnesota, 55101
North Carolina
Messino Cancer Centers – recruiting
Principal Investigator: Andrew Beardsley
Asheville, North Carolina, 28806
Ohio
Oncology Hematology Care Inc – active, not recruiting
Cincinnati, Ohio, 45242
Oregon
Williamette Cancer Center – active, not recruiting
Eugene, Oregon, 97401
Tennessee
Sarah Cannon Research Institute HCA Healthcare Research Inst. – recruiting
Principal Investigator: Stephen Strickland
Nashville, Tennessee, 37203
Texas
Texas Oncology PA Bedford – recruiting
Principal Investigator: Henrik Illum
Bedford, Texas, 76022
Texas Oncology Midtown – recruiting
Principal Investigator: Jason M Melear
Dallas, Texas, 75251
Lumi Research – recruiting
Saleha Sajid
Kingwood, Texas, 77339
Virginia
Virginia Oncology Associates VOA – Princess Anne – recruiting
Principal Investigator: Celeste Bremer
Norfolk, Virginia, 23502