Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
Recruiting now
Conditions studied: Chronic Myeloid Leukemia in Chronic Phase
In brief
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.
Key facts
- Study ID
- NCT07375355
- Run by
- Novartis Pharmaceuticals
- People needed
- 200
- Starts
- 2026-02-12
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients eligible for inclusion in this study must meet all the following criteria:
- 18 years or older at the time of ICF signing;
- 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.
- Prior treatment with a maximum of 2 weeks of TKIs;
- Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;
- Patients scheduled to initiate treatment with asciminib;
- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;
- Signed ICF.
You may not qualify if…
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- Previous diagnosis of CML-accelerated phase or blast crisis;
- Currently participating in an interventional clinical study for CML;
- Having rare, atypical transcript types that cannot be standardised internationally;
- Women who are pregnant, lactating or planning to become pregnant during the study;
- Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);
- Other conditions that are considered not suitable for the study by the investigator.
Where it is running
- Novartis Investigative Site — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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