Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China (ASC4CN)

Novartis

Status: Begins enrollment this month

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Study type: Observational

Funder types: Industry

Identifiers

NCT07375355

CABL001J1CN01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Study Group

Description:

Asciminib treatment