newly diagnosed CML-CP patients
Conditions
Interventions
Asciminib treatment group:
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Molecular Response, MMR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events;treatment adherence; | — |
Countries
China
Contacts
Public ContactHu Yu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed