Retrospective Study on Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia (CML) in Kuwait
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 400
- Primary Endpoint
- Number of Patients by Demographic Category
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Patients not fulfilling any of the above-mentioned inclusion criteria.
Arms & Interventions
CML Cohort
Adult patients diagnosed with CML who received at least one line of TKI treatment between January 2014 and January 2024.
Outcomes
Primary Outcomes
Number of Patients by Demographic Category
Time Frame: Baseline
Demographics include gender and ethnicity.
Age at Diagnosis
Time Frame: Baseline
Number of Patients by Disease Characteristics at Diagnosis
Time Frame: Baseline
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(Up to approximately 10 years)
- Time-to-Treatment(Up to approximately 10 years)
- Duration of Each Line of TKI Treatment(Up to approximately 10 years)
- Initial and Maximum TKI Daily Dose(Up to approximately 10 years)
- Number and Percentage of Patients With a Dose Escalation(Up to approximately 10 years)
- Number and Percentage of Patients who Switch TKI Treatment Across All Treatment Lines(Up to approximately 10 years)
- Number of Treatment Modifications by Type of Modification(Up to approximately 10 years)
- Number of Treatment Modifications by Reason for Modification(Up to approximately 10 years)
- Proportion of Patients Achieving Predefined BCR-ABL1 Quantitative Polymerase Chain Reaction (Q-PCR) Transcript Levels(3, 6, and 12 months, and annually thereafter up to approximately 10 years)
- Percentage of Patients Achieving Complete Hematological Response (CHR)(3, 6, and 12 months)
- CHR Rate for Each Line of Treatment(3, 6, and 12 months)
- Percentage of Patients Achieving Complete Cytogenetic Response (CcyR)(3, 6, and 12 months)
- Overall Survival (OS)(Up to approximately 10 years)
- Event-Free Survival (EFS)(Up to approximately 10 years)
- Transformation-Free Survival(Up to approximately 10 years)
- Proportion of Patients Achieving Treatment-Free Remission (TFR) ≥12 months(Up to approximately 10 years)
- Percentage of Patients who Die While on TKI Treatment(Up to approximately 10 years)
- Time From Diagnosis to Death(Up to approximately 10 years)
- Time From Initiation of Each Line of TKI Treatment to Death(Up to approximately 10 years)
- Number of Patients by Charlson Comorbidity Index (CCI) Score(Baseline)
- Number of Patients by Comorbidity at the Start of Each Line of Treatment(Up to approximately 10 years)
- Number of Patients by Comorbidity During Each Line of TKI Treatment(Up to approximately 10 years)
- Association Between Comorbidities and Treatment Selection(Up to approximately 10 years)
- Association Between Comorbidities and Treatment Adjustments(Up to approximately 10 years)
- Association Between the Presence of Comorbidities at Diagnosis and the Achievement of Major Molecular Response (MMR)(12 months)
- Correlation Between Comorbidity Development During Treatment and the Achievement of Complete/Deep Molecular Response (DMR)(Up to approximately 10 years)