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NCT Number: NCT07454850

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

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Key information

Conditions

Leukemia, Myeloid, Chronic-Phase Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Patients by Demographic Category

    Time frame: Baseline

    Demographics include gender and ethnicity.

  2. Age at Diagnosis

    Time frame: Baseline

  3. 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

  1. Number and Percentage of Patients by TKI and Line of Therapy

    Time frame: Up to approximately 10 years

  2. Time-to-Treatment

    Time frame: Up to approximately 10 years

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

  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

  5. Number and Percentage of Patients With a Dose Escalation

    Time frame: Up to approximately 10 years

  6. Number and Percentage of Patients who Switch TKI Treatment Across All Treatment Lines

    Time frame: Up to approximately 10 years

  7. Number of Treatment Modifications by Type of Modification

    Time frame: Up to approximately 10 years

    Treatment modifications include dose reduction, dose escalation, interruption, and switching.

  8. Number of Treatment Modifications by Reason for Modification

    Time frame: Up to approximately 10 years

    Treatment modifications include dose reduction, dose escalation, interruption, and switching.

  9. 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

    Predefined BCR-ABL1 Q-PCR Transcript Levels include:

    • ≤10% BCR::ABL1 International Scale (IS)
    • ≤1% BCR::ABL1 IS
    • ≤0.1% BCR::ABL1 IS

  10. Percentage of Patients Achieving Complete Hematological Response (CHR)

    Time frame: 3, 6, and 12 months

    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.

  11. CHR Rate for Each Line of Treatment

    Time frame: 3, 6, and 12 months

    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.

  12. Percentage of Patients Achieving Complete Cytogenetic Response (CcyR)

    Time frame: 3, 6, and 12 months

    CcyR is defined as the absence of Ph+ve metaphases.

  13. Overall Survival (OS)

    Time frame: Up to approximately 10 years

    OS is defined as the period from the initiation of treatment until death from any cause at any time.

  14. Event-Free Survival (EFS)

    Time frame: Up to approximately 10 years

    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.

  15. Transformation-Free Survival

    Time frame: Up to approximately 10 years

    Transformation-free survival will be calculated from the initiation of treatment to transformation to accelerated phase or blast phase or death during study treatment.

  16. Proportion of Patients Achieving Treatment-Free Remission (TFR) ≥12 months

    Time frame: Up to approximately 10 years

  17. Percentage of Patients who Die While on TKI Treatment

    Time frame: Up to approximately 10 years

  18. Time From Diagnosis to Death

    Time frame: Up to approximately 10 years

  19. Time From Initiation of Each Line of TKI Treatment to Death

    Time frame: Up to approximately 10 years

  20. Number of Patients by Charlson Comorbidity Index (CCI) Score

    Time frame: Baseline

    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).

  21. Number of Patients by Comorbidity at the Start of Each Line of Treatment

    Time frame: Up to approximately 10 years

  22. Number of Patients by Comorbidity During Each Line of TKI Treatment

    Time frame: Up to approximately 10 years

  23. Association Between Comorbidities and Treatment Selection

    Time frame: Up to approximately 10 years

    Multivariate regression analysis will be performed to assess the association between comorbidities and treatment selection.

  24. Association Between Comorbidities and Treatment Adjustments

    Time frame: Up to approximately 10 years

    Multivariate regression analysis will be performed to assess the association between comorbidities and treatment adjustments.

  25. Association Between the Presence of Comorbidities at Diagnosis and the Achievement of Major Molecular Response (MMR)

    Time frame: 12 months

    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.

  26. Correlation Between Comorbidity Development During Treatment and the Achievement of Complete/Deep Molecular Response (DMR)

    Time frame: Up to approximately 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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