ASC4OPT = Asciminib treatment optimization in ≥ 3rd line CML-CP [Argentina, Canada, Europe, Republic of Korea, Malaysia, Russian Federation, Singapore]

What is the purpose of the study

This is a study to optimize the treatment of asciminib in CML-CP patients without T315I mutation who have had at least 2 prior TKIs.

The study will assess the use of two different dosages of asciminib, 40 mg twice daily or 80 mg once daily.

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 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