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

Retrospective Study on Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia (CML) in Kuwait

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 Overview

• Status: Not yet recruiting
• Conditions: Leukemia, Myeloid, Chronic-Phase

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with CML who were treated in a tertiary care center in Kuwait between January 2014 and January 2024.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CML Cohort; Adult patients diagnosed with CML who received at least one line of TKI treatment between January 2014 and January 2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients by Demographic Category	Demographics include gender and ethnicity.	Baseline
Age at Diagnosis		Baseline
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)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Patients by TKI and Line of Therapy		Up to approximately 10 years
Time-to-Treatment	Time-to-treatment is defined as the number of days between CML diagnosis and treatment initiation.	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	Treatment modifications include dose reduction, dose escalation, interruption, and switching.	Up to approximately 10 years
Number of Treatment Modifications by Reason for Modification	Treatment modifications include dose reduction, dose escalation, interruption, and switching.	Up to approximately 10 years
Proportion of Patients Achieving Predefined BCR-ABL1 Quantitative Polymerase Chain Reaction (Q-PCR) Transcript Levels	Predefined BCR-ABL1 Q-PCR Transcript Levels include: ≤10% BCR::ABL1 International Scale (IS); ≤1% BCR::ABL1 IS; ≤0.1% BCR::ABL1 IS	3, 6, and 12 months, and annually thereafter up to approximately 10 years
Percentage of Patients Achieving Complete Hematological Response (CHR)	CHR is defined as a white blood cell count of less than 10×10^9/L, no immature cells (myelocytes, promyelocytes, or blasts), platelets <450×10^9/L, and a non-palpable spleen.	3, 6, and 12 months
CHR Rate for Each Line of Treatment	CHR is defined as a white blood cell count of less than 10×10^9/L, no immature cells (myelocytes, promyelocytes, or blasts), platelets <450×10^9/L, and a non-palpable spleen.	3, 6, and 12 months
Percentage of Patients Achieving Complete Cytogenetic Response (CcyR)	CcyR is defined as the absence of Ph+ve metaphases.	3, 6, and 12 months
Overall Survival (OS)	OS is defined as the period from the initiation of treatment until death from any cause at any time.	Up to approximately 10 years
Event-Free Survival (EFS)	Event-free-survival will be calculated from the initiation of treatment to loss of CHR, loss of major cytogenetic response, transformation to accelerated phase or blast phase, or death from any cause during study treatment.	Up to approximately 10 years
Transformation-Free Survival	Transformation-free survival will be calculated from the initiation of treatment to transformation to accelerated phase or blast phase or death during study treatment.	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	The CCI score is used to predict the 10-year survival in patients with several comorbid diseases. Comorbidity is assessed using the CCI, categorized as low (0-1) and high (≥2).	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	Multivariate regression analysis will be performed to assess the association between comorbidities and treatment selection.	Up to approximately 10 years
Association Between Comorbidities and Treatment Adjustments	Multivariate regression analysis will be performed to assess the 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)	MMR is defined as ≤0.1% BCR::ABL1 IS. Multivariate regression analysis will be performed to assess the association between the presence of comorbidities at diagnosis and achieving MMR.	12 months
Correlation Between Comorbidity Development During Treatment and the Achievement of Complete/Deep Molecular Response (DMR)	DMR is defined as ≤0.01% BCR::ABL1 [IS], MR4.0; ≤0.0032% BCR::ABL1 [IS], MR4.5. Multivariate regression analysis will be performed to assess the correlation between the comorbidity development and achieving DMR.	Up to approximately 10 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): October 19, 2026

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Myeloid Leukemia; CML
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: CABL001AKW01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO