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

NCT07375355 | Recruiting

• 1 other identifier: CABL001J1CN01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 asciminib's clinical benefits.

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Keywords

CML-CP; Asciminib

Outcome Measures

Primary Outcomes (1)

• Cumulative rate of MMR

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

  Month 12

Secondary Outcomes (23)

• Cumulative rate of MMR

  Month 3, Month 6, Month 9, Month 18 and Month 24

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

  Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24

• Cumulative rate of complete cytogenetic response (CCyR)

  Month 3, Month 6, and Month 12

• Time to first MMR

  24 month follow up period

• Time to first MR4 and MR4.5

  24 month follow up period

Study Arms (1)

Study Group

Asciminib treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Wuhan, Hubei, 430022, China

RECRUITING

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)