Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia in Chronic Phase | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study Group
- description
- Asciminib treatment
Primary outcomes (1)
- measure
- Cumulative rate of MMR
- timeFrame
- Month 12
- description
- Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months
Secondary outcomes (23)
- measure
- Cumulative rate of MMR
- timeFrame
- Month 3, Month 6, Month 9, Month 18 and Month 24
- description
- The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period
- measure
- Cumulative rate of deep molecular response (DMR): MR4 and MR4.5
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available