ASC4CN (CABL001J1CN01): Real-world Study of Scemblix in Chronic Myeloid Leukemia [China]

What is the purpose of the study

This study will evaluate the efficacy and safety of asciminib as treatment for adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years and older.
• have been newly diagnosed with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) within 3 months before enrollment in this study.
• have been treated with TKIs for no longer than 2 weeks.
• may have received treatment with non-TKI regimens, including interferon and hydroxyurea.

Patients scheduled to start treatment with asciminib must receive the first dose within 14 days of signing the informed consent form.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have had a revious diagnosis of CML in accelerated phase or blast crisis.
• are currently participating in an interventional clinical study for CML.
• having rare, atypical transcript types that cannot be standardised internationally.
• are pregnant, lactating or planning to become pregnant during the study.
• have concurrent other malignancies.

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.

Study centers / principal investigators

China

Novartis Investigative Site
Wuhan, 430022