Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China

Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)

This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre- and post-treatment, and long-term follow-up data, enabling a comprehensive assessment of asciminib's clinical benefits.

Inclusion Criteria:

Patients eligible for inclusion in this study must meet all the following criteria:

1. 18 years or older at the time of ICF signing;

2. Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;

   - The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript.

3. Prior treatment with a maximum of 2 weeks of TKIs;

4. Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;

5. Patients scheduled to initiate treatment with asciminib;

   - Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;

6. Signed ICF.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for inclusion in this study:

1. Previous diagnosis of CML-accelerated phase or blast crisis;
2. Currently participating in an interventional clinical study for CML;
3. Having rare, atypical transcript types that cannot be standardised internationally;
4. Women who are pregnant, lactating or planning to become pregnant during the study;
5. Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);
6. Other conditions that are considered not suitable for the study by the investigator.