About this trial
The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region. The data source for this study will consist of routinely collected clinical information documented within the electronic health records (EHR) of participating centers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)
Adult patients aged ≥ 18 years at the index date (or adult as defined by applicable national regulations)
Documented exposure to asciminib during the identification period (May 2023 to May 2026)
Provision of signed informed consent for secondary use of data, or an ethics committee-approved waiver of consent, where applicable (including for deceased patients or where data were previously collected within the EHR system)
Disqualifiers
Patients who do not meet the eligibility criteria specified above
Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes
Trial population
CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Major Molecular Response (MMR) Rate in Young Adults
MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
Secondary outcomes
Incidence of Adverse Events (AEs)
Number of Patients by Type and Severity of AEs
Number of patients by type and severity of AEs including serious AEs and grade ≥ 3 AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Incidence of AEs Leading to Dose Modifications
Dose modifications include treatment interruptions and dose reductions.
Number of Treatment Interruptions Due to AEs
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: