ClinicalTrialsFinder
RecruitingNCT07375355

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)

Sponsor

Novartis Pharmaceuticals

Enrollment

200 participants

Start Date

Feb 12, 2026

Study Type

OBSERVATIONAL

Conditions

Chronic Myeloid Leukemia in Chronic Phase

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Locations(1)

Novartis Investigative Site

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07375355