Chronic Myeloid Leukemia in Chronic PhaseASC4CNNCT07375355
Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
An observational study of Chronic Myeloid Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Myeloid Leukemia in Chronic Phase
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
China1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Wuhan, Hubei, 430022
About this study
Official title: 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.
- Keywords
- CML-CP, Asciminib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Asciminib treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of MMR
Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months
Measured: Month 12
Secondary outcomes (23)
Cumulative rate of MMR
The cumulative MMR is defined as at least one BCR::ABL1 transcript level ≤ 0.1% during the follow-up period
Measured: Month 3, Month 6, Month 9, Month 18 and Month 24
Cumulative rate of deep molecular response (DMR): MR4 and MR4.5
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
Measured: Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Cumulative rate of complete cytogenetic response (CCyR)
Cumulative CCyR is defined as at least one cytogenetic examination showing 0 Ph+ cells during the follow-up period
Measured: Month 3, Month 6, and Month 12
Time to first MMR
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
Measured: 24 month follow up period
Time to first MR4 and MR4.5
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
Measured: 24 month follow up period
Time to first complete cytogenetic response (CCyR)
Time to first CCyR is defined as the time interval from baseline to the first occurrence of CCyRduring the follow-up period
Measured: 24 month follow up period
Early molecular response (EMR) rate at 3 months
Proportion of patients achieving BCR::ABL1 transcript level ≤10% at M3
Measured: Month 3
Complete hematologic response (CHR) rate
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
Measured: Month 1, Month 2, and Month 3
Rate of decline in BCR::ABL1 transcript levels
indirectly calculated from BCR::ABL1 transcript levels at baseline, M1, M2, M3, M6, M9, and M12; determined by BCR::ABL1 halving time
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12
Duration of MMR
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.
Measured: 24 month follow up period
Duration of MR4 and MR4.5
Measured: 24 month follow-up period
Event-Free survival (EFS) rate
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.
Measured: Month 12 and Month 24
Progression-free survival (PFS) rate
Measured: Month 12 and Month 24
Overall survival (OS) rate
Measured: Month 12 and Month 24
Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment
Measured: 24 month follow-up period
Asciminib persistence rates
Measured: Month 6, Month 12, and Month 24
Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs
Measured: 24 month follow-up period
Proportion of patients requiring concomitant medications due to AEs
Measured: 24 month follow-up period
Change in the simplified CML quality of life questionnaire from baseline
Measured: Baseline, Month 12 and Month 24
Compliance following asciminib treatment
Medication possession ratio
Measured: 24 month follow-up period
Concomitant medication use associated with AEs related to asciminib
Measured: 24 month follow-up period
Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment
Measured: 24 month follow-up period
Gene mutation rate associated with asciminib treatment
Gene mutation rate associated with asciminib treatment; types and proportions of positive gene mutations identified via genetic testing.
Measured: 24 month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start12 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia in Chronic PhaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375355
- Sponsor's protocol ID
- CABL001J1CN01
- Acronym
- ASC4CN
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)
- ClinicalTrials.gov ID
- NCT07375355
- Acronym / sponsor ID
- ASC4CN / CABL001J1CN01
- Keywords
- CML-CP, Asciminib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Asciminib treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records
Key inclusion criteria (9 listed)
- 18 years or older at the time of ICF signing;
- Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
23 secondary outcomes
Cumulative rate of MMR
Time frame: 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 complete cytogenetic response (CCyR)
Time frame: Month 3, Month 6, and Month 12
Time to first MMR
Time frame: 24 month follow up period
Time to first MR4 and MR4.5
Time frame: 24 month follow up period
Time to first complete cytogenetic response (CCyR)
Time frame: 24 month follow up period
Early molecular response (EMR) rate at 3 months
Time frame: Month 3
Complete hematologic response (CHR) rate
Time frame: 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
Duration of MMR
Time frame: 24 month follow up period
Duration of MR4 and MR4.5
Time frame: 24 month follow-up period
Event-Free survival (EFS) rate
Time frame: Month 12 and Month 24
Progression-free survival (PFS) rate
Time frame: Month 12 and Month 24
Overall survival (OS) rate
Time frame: Month 12 and Month 24
Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment
Time frame: 24 month follow-up period
Asciminib persistence rates
Time frame: 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
Proportion of patients requiring concomitant medications due to AEs
Time frame: 24 month follow-up period
Change in the simplified CML quality of life questionnaire from baseline
Time frame: Baseline, Month 12 and Month 24
Compliance following asciminib treatment
Time frame: 24 month follow-up period
Concomitant medication use associated with AEs related to asciminib
Time frame: 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
Gene mutation rate associated with asciminib treatment
Time frame: 24 month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rate of MMR (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.