Not yet recruitingNCT07454850ClinicalTrials.gov record

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

Leukemia, Myeloid, Chronic-Phase

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 21 years - 90 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 400 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 population

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

CML Cohort

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Number of Patients by Demographic Category

Time frame: Baseline

Demographics include gender and ethnicity.

Age at Diagnosis

Time frame: Baseline

Not reported in this registry record.

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 measures

Number and Percentage of Patients by TKI and Line of Therapy

Time frame: Up to approximately 10 years

Not reported in this registry record.

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.

Duration of Each Line of TKI Treatment

Time frame: Up to approximately 10 years

Not reported in this registry record.

Initial and Maximum TKI Daily Dose

Time frame: Up to approximately 10 years

Not reported in this registry record.

Number and Percentage of Patients With a Dose Escalation

Time frame: Up to approximately 10 years

Not reported in this registry record.

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

Time frame: Up to approximately 10 years

Not reported in this registry record.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

Time frame: Up to approximately 10 years

Not reported in this registry record.

Percentage of Patients who Die While on TKI Treatment

Time frame: Up to approximately 10 years

Not reported in this registry record.

Time From Diagnosis to Death

Time frame: Up to approximately 10 years

Not reported in this registry record.

Time From Initiation of Each Line of TKI Treatment to Death

Time frame: Up to approximately 10 years

Not reported in this registry record.

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).

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

Time frame: Up to approximately 10 years

Not reported in this registry record.

Number of Patients by Comorbidity During Each Line of TKI Treatment

Time frame: Up to approximately 10 years

Not reported in this registry record.

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.

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.

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.

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (0)

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No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor: Novartis Pharmaceuticals
Study start: Jan 31, 2027 Estimated
Primary completion: Jul 2, 2027 Estimated
Study completion: Jul 2, 2027 Estimated
First posted: Mar 6, 2026 Actual
Last updated: Nov 10, 2026 Actual

Official study contacts

Novartis PharmaceuticalsCONTACTnovartis.email@novartis.com +41613241111

Novartis PharmaceuticalsCONTACT

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026