ASC4FIRST = Oral Asciminib Versus Other TKIs in Newly Diagnosed Ph+ CML-CP [Asia-Pacific, Australia, Europe, Israel, North America, Russian Federation]
Type of study
First line trial
Phase
Current status
Recruiting
Study title
ASC4FIRST = A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Scientific title
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Other trial ID
(ClinicalTrials.gov NCT04971226, EudraCT no. 2021-000678-27)
What is the purpose of the study
This is a study to compare the efficacy of asciminib 80 mg once daily with a tyrosine kinase inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The TKI will be selected by the investigator and will be either imatinib 400 mg once daily or nilotinib 300 mg twice daily or dasatinib 100 mg once daily or bosutinib 400 mg once daily.
What will happen during the study
Patients will be randomly assigned to one of two treatment arms.
Participants in Arm 1 will receive asciminib 80 mg once daily under fasting conditions.
Participants in Arm 2 will receive investigator selected TKI that will include one of the below treatments:
- imatinib 400 mg once daily administered with food, or
- niilotinib 300 mg twice daily administered under fasting conditions, or
- dasatinib 100 mg once daila administered with or without meal, or
- bosutinib 400 mg once daily administered with food.
Key inclusion criteria
This study includes male or female patients who:
- are aged 18 years or older
- have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) within 3 months of study entry.
Key exclusion criteria
This study does not include patients who:
- have been treated 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. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤2 weeks is allowed, but no other treatment with other tyrosine kinase inhibitors prior to randomization is permitted.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study descripiton in the EU Clinical Trials Registry which is hosted by the European Medicines Agency (EMA)
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
Study centers / principal investigators
Australia
Novartis Investigative Site
SouthPort, 4215
Novartis Investigative Site
Kingswood, New South Wales, 2747
Novartis Investigative Site
Port Macquarie, New South Wales, 2444
Austria
Novartis Investigative Site
Linz, 4010
Novartis Investigative Site
Vienna, 1090
Belgium
Novartis Investigative Site
Bruxelles, 1000
Novartis Investigative Site
Leuven, 3000
Bulgaria
Novartis Investigative Site
Sofia, 1797
Novartis Investigative Site
Varna, 9010
Canada
Alberta
Novartis Investigative Site
Calgary, Alberta, T2N 4N2
Ontario
Novartis Investigative Site
Hamilton, Ontario, L8V 1C3
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
China
Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Lanzhou
Novartis Investigative Site
Shanghai, 200025
China, Anhui
Novartis Investigative Site
Hefei, Anhui, 230001
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Shenzhen, Guangdong, 518037
China, Henan
Novartis Investigative Site
Zhengzhou, Henan, 450008
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, 430022
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu
Novartis Investigative Site
Nantong, Jiangsu, 226000
Novartis Investigative Site
Suzhou, Jiangsu, 215006
China, Shanxi
Novartis Investigative Site
Xian, Shanxi, 710068
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, 610041
China, Tianjin
Novartis Investigative Site
Tianjin, Tianjin, 300020
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Czechia, Czech Republic
Novartis Investigative Site
Brno Bohunice, 625 00
Novartis Investigative Site
Hradec Kralove, 500 05
Novartis Investigative Site
Ostrava, Poruba, 708 52
Denmark
Novartis Investigative Site
Aarhus, 8000
Novartis Investigative Site
Copenhagen, 2100
Novartis Investigative Site
Roskilde, 4000
Finland
Novartis Investigative Site
Helsinki, 00290
Novartis Investigative Site
Turku, 20520
France
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Lyon Cedex, 69373
Novartis Investigative Site
Nantes Cedex 1, 44093
Novartis Investigative Site
Paris Cedex, 75475
Germany
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mannheim, 68305
Hungary
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvar, 7400
Novartis Investigative Site
Kecskemet, 6001
India
Novartis Investigative Site
Delhi, 110 085
Israel
Novartis Investigative Site
Petah Tikva
Novartis Investigative Site
Ramat Gan, 52621
Novartis Investigative Site
Tel Aviv, 6423906
Italy
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Milano, MI, 20122
Novartis Investigative Site
Reggio Emilia, RE, 42123
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Verona, VR, 37126
Japan
Novartis Investigative Site
Akita, 010 8543
Japan, Akita
Novartis Investigative Site
Akita, 010 8543
Japan, Aichi
Novartis Investigative Site
Nagoya, Aichi, 453-8511
Novartis Investigative Site
Toyoake city, Aichi, 470 1192
Japan, Chiba
Novartis Investigative Site
Kashiwa, Chiba, 277 8577
Japan, Fukuoka
Novartis Investigative Site
Fukuoka city, Fukuoka, 812-8582
Japan, Fukushima
Novartis Investigative Site
Fukushima city, Fukushima, 960 1295
Japan, Hokkaido
Novartis Investigative Site
Sapporo city, Hokkaido, 060 8648
Japan, Hyogo
Novartis Investigative Site
Kobe-city, Hyogo, 650-0047
Japan, Okayama
Novartis Investigative Site
Kurashiki-city, Okayama, 710-8602
Japan, Osaka
Novartis Investigative Site
Osaka, 545-8586
Novartis Investigative Site
Osaka Sayama, Osaka, 589 8511
Novartis Investigative Site
Suita city, Osaka, 565 0871
Japan, Shizuoka
Novartis Investigative Site
Sunto Gun, Shizuoka, 411 8777
Japan, Tochigi
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Japan, Yamagata
Novartis Investigative Site
Yamagata, 990 9585
Japan, Yamanashi
Novartis Investigative Site
Chuo-city, Yamanashi, 409-3898
Korea, Republic of
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759
Malaysia
Novartis Investigative Site
Kuantan, 25100
Novartis Investigative Site
Pulau Pinang, 10990
Novartis Investigative Site
Selangor, 68000
Novartis Investigative Site
Subang Jaya, 47500
Norway
Novartis Investigative Site
Bergen, 5021
Novartis Investigative Site
Oslo, 0372
Novartis Investigative Site
Trondheim, 7006
Portugal
Novartis Investigative Site
Porto, 4200 072
Novartis Investigative Site
Vila Nova de Gaia, 4434 502
Russian Federation
Novartis Investigative Site
Moscow, 127644
Novartis Investigative Site
Saint Petersburg, 191024
Singapore
Novartis Investigative Site
Singapore, 119228
Novartis Investigative Site
Singapore, 169608
Slovakia
Novartis Investigative Site
Bratislava, 83310
Novartis Investigative Site
Kosice, 040 66
Spain
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
El Palmar, 30120
Novartis Investigative Site
Granada, 18014
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Pamplona, 31008
Sweden
Novartis Investigative Site
Goteborg, 413 45
Novartis Investigative Site
Lund 221 85
Novartis Investigative Site
Stockholm; 141 86
Switzerland
Novartis Investigative Site
Bellinzona, 6850
Novartis Investigative Site
Zurich, 8091
Taiwan
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Taichung, 40447
United Kingdom
Novartis Investigative Site
London, W12 0HS
Novartis Investigative Site
Nottingham, NG5
Novartis Investigative Site
Oxford, OX3 7LJ
United States
California
City of Hope National Medical Center
Duarte, California, 91010
Principal Investigator: Paul Koller
Colorado
Rocky Mountain Cancer Center
Denver, Colorado, 80501
Principal Investigator: David J Andorsky
Florida
Florida Cancer Specialists Dept. of Oncology
Fort Myers. Florida, 33901
Principal Investigator: Vijay Patel
Florida Cancer Specialists
Fort Myers. Florida, 33901
Principal Investigator: Anjan J Patel
Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Principal Investigator: Pareshkumar Patel
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Principal Investigator: Shachar Peles
Illinois
Illinois Cancer Care P.C. IL Cancer Specialists
Chicago, Illinois, 61615-7828
Principal Investigator: Leonard Klein
Kentucky
University of Kentucky
Lexington, Kentucky, 40536
Principal Investigator: Reinhold Munker
Massachusetts
University of Massachusetts Medical Center Dept of Oncology
Worcester, Massachusetts, 01655
Principal Investigator: Jonathan Gerber
Michigan
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109
Principal Investigator: Moshe Talpaz
North Carolina
Wake Forest University Baptist Medical Center Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Principal Investigator: Edward R Broun
Oregon
Williamette Cancer Center
Eugene, Oregon, 97401
Principal Investigator: Luke Fletcher
South Dakota
Avera Cancer Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Principal Investigator: Roberto Ferro Valdes
Tennessee
Chattanooga Oncology and Hematologiy Associates PC
Tennessee Oncology Chattanooga
Principal Investigator: Bertrand Marquess Anz
Texas
Texas Oncology Texas Onc – Amarillo
Dallas, Texas, 75246
Principal Investigator: Praveen Kumar Tumula
Texas Oncology-Baylor USO
Dallas, Texas, 75246
Principal Investigator: Moshe Levy
Texas Oncology P A Austin
Dallas, Texas, 75251
Principal Investigator: Jason M Melear
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Ghayas C Issa
Texas Oncology Northeast Texas
Tyler, Texas, 75702
Principal Investigator: Habte Yimer
Virginia
Virginia Cancer Specialists
Gainesville, Virginia, 20155
Principal Investigator: Mitul Gandhi
Virginia Oncology Associates
Norfolk, Virginia, 23502
Principal Investigator: Celeste Bremer