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NCT Number: NCT07375355

Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China

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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Key information

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Cumulative rate of MMR

    Time frame: Month 12

    Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months

Secondary outcomes

  1. Cumulative rate of MMR

    Time frame: Month 3, Month 6, Month 9, Month 18 and Month 24

    The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period

  2. Cumulative rate of deep molecular response (DMR): MR4 and MR4.5

    Time frame: Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24

    Cumulative rate of MR4 is defined as at least one BCR::ABL1 transcript level ≤ 0.01% during the follow-up period; Cumulative MR4.5 is defined as at least one BCR::ABL1 transcript level ≤0.0032% during the follow-up period

  3. Cumulative rate of complete cytogenetic response (CCyR)

    Time frame: Month 3, Month 6, and Month 12

    Cumulative CCyR is defined as at least one cytogenetic examination showing 0 Ph+ cells during the follow-up period

  4. Time to first MMR

    Time frame: 24 month follow up period

    Time to first MMR is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.1% during the follow-up period

  5. Time to first MR4 and MR4.5

    Time frame: 24 month follow up period

    Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.01% during the follow-up period.

    Time to first MR4 is defined as the time interval from baseline to the first occurrence of BCR::ABL1 transcript level ≤0.0032% during the follow-up period

  6. Time to first complete cytogenetic response (CCyR)

    Time frame: 24 month follow up period

    Time to first CCyR is defined as the time interval from baseline to the first occurrence of CCyRduring the follow-up period

  7. Early molecular response (EMR) rate at 3 months

    Time frame: Month 3

    Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3

  8. Complete hematologic response (CHR) rate

    Time frame: Month 1, Month 2, and Month 3

    the proportion of patients achieving white blood cell count < 10 × 109/L, platelet count < 450 × 109/L, no immature myeloid cells in peripheral blood, peripheral blood basophil percentage < 5%, absence of symptoms/signs of extramedullary involvement, and non-palpable spleen at M1, M2, and M3

  9. Rate of decline in BCR::ABL1 transcript levels

    Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12

    indirectly calculated from BCR::ABL1 transcript levels at baseline, M1, M2, M3, M6, M9, and M12; determined by BCR::ABL1 halving time

  10. Duration of MMR

    Time frame: 24 month follow up period

    Definition of duration: Duration = sum of "intervals"; Interval calculation method: the first visit at which a response is achieved (and previously unmeasured) within the interval is taken as the starting point, then evaluated sequentially in time order; the calculation stops upon encountering a visit that fails to meet the criterion; The duration is calculated as the time interval between the first and last visit at which the response was achieved; Missing visit data points during this period will be defaulted as achieving the response.

  11. Duration of MR4 and MR4.5

    Time frame: 24 month follow-up period

  12. Event-Free survival (EFS) rate

    Time frame: Month 12 and Month 24

    Lack of efficacy:

    • Failure to achieve expected molecular response: failure to reach the molecular response milestones recommended by the ELN guidelines at prespecified time points;
    • Loss of molecular response: loss of confirmed MMR following achievement of MMR, or loss of CCyR.

    Disease progression: progression from the chronic phase to the accelerated phase or blast crisis.

    Death: fatal outcome due to any cause during the treatment period. Treatment discontinuation due to adverse events: permanent discontinuation caused by intolerable toxicity, serious adverse events, or other safety-related reasons associated with the study drug.

  13. Progression-free survival (PFS) rate

    Time frame: Month 12 and Month 24

  14. Overall survival (OS) rate

    Time frame: Month 12 and Month 24

  15. Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment

    Time frame: 24 month follow-up period

  16. Asciminib persistence rates

    Time frame: Month 6, Month 12, and Month 24

  17. Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs

    Time frame: 24 month follow-up period

  18. Proportion of patients requiring concomitant medications due to AEs

    Time frame: 24 month follow-up period

  19. Change in the simplified CML quality of life questionnaire from baseline

    Time frame: Baseline, Month 12 and Month 24

  20. Compliance following asciminib treatment

    Time frame: 24 month follow-up period

    Medication possession ratio

  21. Concomitant medication use associated with AEs related to asciminib

    Time frame: 24 month follow-up period

  22. Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment

    Time frame: 24 month follow-up period

  23. Gene mutation rate associated with asciminib treatment

    Time frame: 24 month follow-up period

    Gene mutation rate associated with asciminib treatment; types and proportions of positive gene mutations identified via genetic testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)

Acronym: ASC4CN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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