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

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

This project will try asciminib (Scemblix) in adults newly diagnosed with chronic-phase CML to see if it controls the disease and is safe.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (industry)
• Drugs / interventions: asciminib
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07375355 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) newly diagnosed with Philadelphia-positive chronic-phase CML within 3 months, with documented BCR-ABL1 transcript levels, minimal prior TKI exposure (≤2 weeks), and planning to start asciminib within 14 days of consent are ideal candidates.

Not a fit: Patients with a prior diagnosis of accelerated-phase or blast-crisis CML, those currently enrolled in other interventional CML trials, or those with rare unstandardizable BCR-ABL1 transcripts are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, asciminib could offer an effective and possibly better-tolerated frontline option for adults with newly diagnosed chronic-phase CML in China.

How similar studies have performed: Asciminib has shown benefit in prior clinical trials for patients with TKI-resistant or -intolerant CML, but real-world data in newly diagnosed frontline patients remain limited, so this use is partly building on past success while being relatively novel for first-line care.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

• Novartis Investigative Site — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Chronic Myeloid Leukemia in Chronic Phase, CML-CP, Asciminib