NCT07375355 Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
| NCT ID | NCT07375355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Chronic Myeloid Leukemia in Chronic Phase |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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Brief Summary
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 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 wh
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