AzTrials
AzTrials

Leukemia, Myeloid, Chronic-PhaseNCT07454850

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

An observational study of Leukemia, Myeloid, Chronic-Phase, run by Novartis Pharmaceuticals.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Leukemia, Myeloid, Chronic-Phase
How many people
400 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 30 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • Patients not fulfilling any of the above-mentioned inclusion criteria.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

About this study

Official title: 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.

Keywords
CML, Chronic Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07454850
Study groupRoleWhat they receive
CML CohortAdult patients diagnosed with CML who received at least one line of TKI treatment between January 2014 and January 2024.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients by Demographic Category

    Demographics include gender and ethnicity.

    Measured: Baseline

  2. Age at Diagnosis

    Measured: 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)

    Measured: Baseline

Secondary outcomes (26)

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

    Measured: 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.

    Measured: Up to approximately 10 years

  3. Duration of Each Line of TKI Treatment

    Measured: Up to approximately 10 years

  4. Initial and Maximum TKI Daily Dose

    Measured: Up to approximately 10 years

  5. Number and Percentage of Patients With a Dose Escalation

    Measured: Up to approximately 10 years

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

    Measured: Up to approximately 10 years

  7. Number of Treatment Modifications by Type of Modification

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

    Measured: Up to approximately 10 years

  8. Number of Treatment Modifications by Reason for Modification

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

    Measured: Up to approximately 10 years

  9. 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

    Measured: 3, 6, and 12 months, and annually thereafter up to approximately 10 years

  10. 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.

    Measured: 3, 6, and 12 months

  11. 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.

    Measured: 3, 6, and 12 months

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

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

    Measured: 3, 6, and 12 months

  13. Overall Survival (OS)

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

    Measured: Up to approximately 10 years

  14. 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.

    Measured: Up to approximately 10 years

  15. 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.

    Measured: Up to approximately 10 years

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

    Measured: Up to approximately 10 years

  17. Percentage of Patients who Die While on TKI Treatment

    Measured: Up to approximately 10 years

  18. Time From Diagnosis to Death

    Measured: Up to approximately 10 years

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

    Measured: Up to approximately 10 years

  20. 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).

    Measured: Baseline

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

    Measured: Up to approximately 10 years

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

    Measured: Up to approximately 10 years

  23. Association Between Comorbidities and Treatment Selection

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

    Measured: Up to approximately 10 years

  24. Association Between Comorbidities and Treatment Adjustments

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

    Measured: Up to approximately 10 years

  25. 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.

    Measured: 12 months

  26. 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.

    Measured: Up to approximately 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07454850
Sponsor's protocol ID
CABL001AKW01
Status last verified
Sep 2026
First submitted
3 Mar 2026
Last updated
1 Oct 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Myeloid, Chronic-Phase, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients by Demographic Category (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in