A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leukemia, Myeloid, Chronic-Phase. Basic parameters: 21 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective Study on Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia (CML) in Kuwait
Overview
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.
Primary outcome measures
- Number of Patients by Demographic Category [Time frame: Baseline]
- Age at Diagnosis [Time frame: Baseline]
- Number of Patients by Disease Characteristics at Diagnosis [Time frame: Baseline]
Secondary outcome measures (12)
- Number and Percentage of Patients by TKI and Line of Therapy [Time frame: Up to approximately 10 years]
- Time-to-Treatment [Time frame: Up to approximately 10 years]
- Duration of Each Line of TKI Treatment [Time frame: Up to approximately 10 years]
- Initial and Maximum TKI Daily Dose [Time frame: Up to approximately 10 years]
- Number and Percentage of Patients With a Dose Escalation [Time frame: Up to approximately 10 years]
- Number and Percentage of Patients who Switch TKI Treatment Across All Treatment Lines [Time frame: Up to approximately 10 years]
- Number of Treatment Modifications by Type of Modification [Time frame: Up to approximately 10 years]
- Number of Treatment Modifications by Reason for Modification [Time frame: Up to approximately 10 years]
- Proportion of Patients Achieving Predefined BCR-ABL1 Quantitative Polymerase Chain Reaction (Q-PCR) Transcript Levels [Time frame: 3, 6, and 12 months, and annually thereafter up to approximately 10 years]
- Percentage of Patients Achieving Complete Hematological Response (CHR) [Time frame: 3, 6, and 12 months]
- CHR Rate for Each Line of Treatment [Time frame: 3, 6, and 12 months]
- Percentage of Patients Achieving Complete Cytogenetic Response (CcyR) [Time frame: 3, 6, and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07454850 · CABL001AKW01