About this trial
The goal of this observational study is to evaluate the efficacy and tolerability of asciminib in real-life in patients with chronic myeloid leukemia treated in second or subsequent lines. The main object of the study is to assess the achievement of Major Molecular Response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years and no upper age limit;
Patients with a diagnosis of CML-CP who started treatment with asciminib according to clinical practice - from the date of commercial availability of asciminib - until the end of recruitment period (two years after the first patient included);
Patients treated with asciminib in second or subsequent lines of therapy (≥2L)
Patients who provide written informed consent to participate in the study (if applicable).
Disqualifiers
None
Trial population
The study will include all adult patients with chronic-phase chronic myeloid leukemia (CML-CP) who initiated second-line or subsequent lines of therapy with asciminib after the date of its commercial availability. In detail, treatment with asciminb in third or greater line was approved in July 2023, while treatment in the other lines of therapy was approved by EMA in December 2025. Patients will be included according to these timelines.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluation of response to asciminib
Proportion of patients achieving Major Molecular Response (MMR) by RT-PCR at 24 months after the start of asciminib treatment
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: