NCT07375355Recruiting
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)
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 12 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07375355
What you commit to
- Study type: Observational
- Planned participants: 200
- From 12 Feb 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of CML-accelerated phase or blast crisis;
- Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);
Other illness
- Other conditions that are considered not suitable for the study by the investigator.
Other
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.