ASC4OPT = Asciminib treatment optimization in ≥ 3rd line CML-CP [Argentina, Canada, Europe, Republic of Korea, Malaysia, Russian Federation, Singapore]
Study title
ASC4OPT = Asciminib treatment optimization in ≥ 3rd line CML-CP
Scientific title
A Phase 3b, Multi-center, Open-label, Treatment Optimization Study of Oral Asciminib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Previously Treated With 2 or More Tyrosine Kinase Inhibitors
Type of study
Therapy optimization trial
Phase
Current status
Active, not recruiting
Other trial ID
CABL001A2302, ClinicalTrials.gov NCT04948333, EudraCT 2020-006057-21
What is the purpose of the study
What will happen during the study
Patients will receive either asciminib 40 mg orally twice daily or 80 mg orally once daily. In patients not achieving major molecular response (MMR) at 48 weeks or losing the response after the week 48 up to week 108, the asciminib dose may be increased to 200 mg orally once daily under certain conditions.
The planned duration of treatment is up to 144 weeks unless patients stop treatment due to unacceptable toxicity, disease progression and/or if treatment is discontinued at the discretion of the investigator or the participant prior to week 144.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have been diagnosed with CML in chronic phase (CML-CP)
- meet the laboratory values specified in the study protocol
- have received at least 2 tyrosine kinase inhibitors (TKI) (imatinib, nilotinib, dasatinib, radotinib or ponatinib) with warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients of all sexes who:
- have had the BCR-ABL1 T315I mutation at any time prior to study entry
- have a known history of CML in advanced phase (AP) or blast crisis (BC)
- have undergone hematopeietic stem cell transplantation or are planning to undergo allogeneic stem cell transplantation.
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 register 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
Novartis Pharmaceuticals
Study centers / principal investigators
Argentina
Novartis Investigative Site
Buenos Aires, C1114AAN
Novartis Investigative Site
Caba, Buenos Aires, C1221ADC
Austria
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Linz, 4010
Novartis Investigative Site
Vienna, 1140
Brazil
Novartis Investigative Site
Sao Paulo, 01236 030
Novartis Investigative Site
Rio de Janeiro, 20211-030
Canada
Novartis Investigative Site
Quebec, G1J 1Z4
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Vancouver, British Columbia; V5Z 1M9
France
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Montpellier Cedex 5, 34295
Novartis Investigative Site
Nantes Cedex 1, 44093
Novartis Investigative Site
Paris Cedex, 75475
Germany
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kiel, 24116
Novartis Investigative Site
Mannheim, 68305
Novartis Investigative Site
Munich, 80377
Greece
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Thessaloniki, 570 10
Italy
Novartis Investigative Site
Monza, 20900
Novartis Investigative Site
Roma, 00144
Novartis Investigative Site
Verona, 37126
Korea, Republic of
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Taegu, 41944
Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, 88586
Novartis Investigative Site
Johor Bahru, 80100
Novartis Investigative Site
Penang, 10990
Novartis Investigative Site
Selangor, 68000
Oman
Novartis Investigative Site
Muscat, 123
Poland
Novartis Investigative Site
Katowice, 40 519
Novartis Investigative Site
Krakow, 31 531
Novartis Investigative Site
Warszawa, 01 776
Russian Federation
Novartis Investigative Site
Moscow, 127644
Singapore
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
Novartis Investigative Site
Singapore, S308433
Spain
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Bilbao, 48013
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Santiago de Compostela, 15706
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
United Kingdom
Novartis Investigative Site
Cambridge, CB2 2QQ
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
London, W12 0HS
Vietnam
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh, 738000