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

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Wuhan, Hubei, China