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Recruiting NCT07375355

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

— Observational Chronic Myeloid Leukemia in Chronic Phase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Myeloid Leukemia in Chronic Phase. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Cumulative rate of MMR [Time frame: Month 12]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Novartis Investigative Site — Wuhan

Identifiers

NCT: NCT07375355 · CABL001J1CN01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗