A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-90
SponsorNovartis Pharmaceuticals

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: CML Cohort

Trial outcomes

Primary outcomes

1

Number of Patients by Demographic Category

Demographics include gender and ethnicity.

Time frame
Baseline
2

Age at Diagnosis

Time frame
Baseline
3

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)

Time frame
Baseline

Secondary outcomes

1

Number and Percentage of Patients by TKI and Line of Therapy

Time frame
Up to approximately 10 years
2

Time-to-Treatment

Time-to-treatment is defined as the number of days between CML diagnosis and treatment initiation.

Time frame
Up to approximately 10 years
3

Duration of Each Line of TKI Treatment

Time frame
Up to approximately 10 years
4

Initial and Maximum TKI Daily Dose

Time frame
Up to approximately 10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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