Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
Recruiting
Observational Study
Chronic Myeloid Leukemia in Chronic Phase
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 99
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
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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.
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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 l…
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.
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