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

Type of study

Therapy optimization trial

Phase

3b

Current status

Recruiting

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 (ClinicalTrials.gov NCT04948333)

Other trial ID

CABL001A2302

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 male or female patients 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.

Key exclusion criteria

This study does not include patients 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

May 2024

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 sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Study centers / principal investigators

Argentina

Novartis Investigative Site
Buenos Aires, C1114AAN


Austria

Novartis Investigative Site
Graz, 8036

Novartis Investigative Site
Linz, 4010

Novartis Investigative Site
Wien, 1140


Canada

Novartis Investigative Site
Quebec, G1J 1Z4


France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Lyon Cedex, 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
Roma, 00161

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


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
Leeds, LS9 7TF

Novartis Investigative Site
London, SE1 9RT

Novartis Investigative Site
London, W12 0HS