About this trial
The aim of this study is to assess demographics, clinical features, treatment patterns, and the comorbidity burden and its impact on CML patients in the real-world clinical setting in Kuwait. Adult patients with Philadelphia positive-chromosome (Ph+ve) CML who have received at least one line of tyrosine kinase inhibitor (TKI) treatment, such as but not limited to imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and asciminib will be included. The study will use data from the hospital records of CML patients between January 2014 and January 2024.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Ph+ve CML based on the European LeukemiaNet (ELN) and National Comprehensive Cancer Network (NCCN) diagnostic criteria.
Received at least one line of TKI therapy.
Having a documented pre-index period (equal to either 6 months prior to the index date or less in case of newly diagnosed patients).
Disqualifiers
None
Trial population
Patients with CML who were treated in a tertiary care center in Kuwait between January 2014 and January 2024.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of Patients by Demographic Category
Demographics include gender and ethnicity.
Age at Diagnosis
Number of Patients by Disease Characteristics at Diagnosis
Disease characteristics include: * Disease phase * BCR-ABL1 status * Level of BCR-ABL1 transcription * Mutations * Risk score (Sokal or European Treatment And Outcome Study score (EUTOS) or according to local hospital utilization) * Baseline laboratory parameters (complete blood count, organ function tests, symptom presence, spleen size)
Secondary outcomes
Number and Percentage of Patients by TKI and Line of Therapy
Time-to-Treatment
Time-to-treatment is defined as the number of days between CML diagnosis and treatment initiation.
Duration of Each Line of TKI Treatment
Initial and Maximum TKI Daily Dose
Locations
Sponsors and contacts
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