Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China (ASC4CN)

March 27, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study Group
Asciminib treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Month 3, Month 6, Month 9, Month 18 and Month 24
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
Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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
Month 3, Month 6, and Month 12
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
24 month follow up period
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
24 month follow up period
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
24 month follow up period
Early molecular response (EMR) rate at 3 months
Time Frame: Month 3
Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3
Month 3
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
Month 1, Month 2, and Month 3
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
Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12
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.
24 month follow up period
Duration of MR4 and MR4.5
Time Frame: 24 month follow-up period
24 month follow-up period
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.
Month 12 and Month 24
Progression-free survival (PFS) rate
Time Frame: Month 12 and Month 24
Month 12 and Month 24
Overall survival (OS) rate
Time Frame: Month 12 and Month 24
Month 12 and Month 24
Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment
Time Frame: 24 month follow-up period
24 month follow-up period
Asciminib persistence rates
Time Frame: Month 6, Month 12, and Month 24
Month 6, Month 12, and Month 24
Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs
Time Frame: 24 month follow-up period
24 month follow-up period
Proportion of patients requiring concomitant medications due to AEs
Time Frame: 24 month follow-up period
24 month follow-up period
Change in the simplified CML quality of life questionnaire from baseline
Time Frame: Baseline, Month 12 and Month 24
Baseline, Month 12 and Month 24
Compliance following asciminib treatment
Time Frame: 24 month follow-up period
Medication possession ratio
24 month follow-up period
Concomitant medication use associated with AEs related to asciminib
Time Frame: 24 month follow-up period
24 month follow-up period
Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment
Time Frame: 24 month follow-up period
24 month follow-up period
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.
24 month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CABL001J1CN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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