Scemblix (asciminib) for newly diagnosed chronic-phase CML in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, non-interventional real-world study prospectively collects baseline, pre-treatment, on-treatment, and long-term follow-up data from adults newly diagnosed with Philadelphia chromosome–positive chronic-phase CML who start asciminib. Eligible patients must have been diagnosed within 3 months, have documented BCR-ABL1 transcript type and level, and may have had up to two weeks of prior TKI exposure; asciminib must be started within 14 days of consent. Treatment decisions are made by the treating physician and the protocol records molecular response, adverse events, treatment patterns, and other clinical outcomes over time. The design aims to describe effectiveness and safety of asciminib during routine clinical care rather than in a controlled randomized setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.