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.
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
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
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.
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- 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 group | Role | What they receive |
|---|---|---|
| CML Cohort | Adult 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.
Number of Patients by Demographic Category
Demographics include gender and ethnicity.
Measured: Baseline
Age at Diagnosis
Measured: 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)
Measured: Baseline
Secondary outcomes (26)
Number and Percentage of Patients by TKI and Line of Therapy
Measured: Up to approximately 10 years
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
Duration of Each Line of TKI Treatment
Measured: Up to approximately 10 years
Initial and Maximum TKI Daily Dose
Measured: Up to approximately 10 years
Number and Percentage of Patients With a Dose Escalation
Measured: Up to approximately 10 years
Number and Percentage of Patients who Switch TKI Treatment Across All Treatment Lines
Measured: Up to approximately 10 years
Number of Treatment Modifications by Type of Modification
Treatment modifications include dose reduction, dose escalation, interruption, and switching.
Measured: Up to approximately 10 years
Number of Treatment Modifications by Reason for Modification
Treatment modifications include dose reduction, dose escalation, interruption, and switching.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3, 6, and 12 months
Percentage of Patients Achieving Complete Cytogenetic Response (CcyR)
CcyR is defined as the absence of Ph+ve metaphases.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 10 years
Proportion of Patients Achieving Treatment-Free Remission (TFR) ≥12 months
Measured: Up to approximately 10 years
Percentage of Patients who Die While on TKI Treatment
Measured: Up to approximately 10 years
Time From Diagnosis to Death
Measured: Up to approximately 10 years
Time From Initiation of Each Line of TKI Treatment to Death
Measured: 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).
Measured: Baseline
Number of Patients by Comorbidity at the Start of Each Line of Treatment
Measured: Up to approximately 10 years
Number of Patients by Comorbidity During Each Line of TKI Treatment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted6 Mar 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, Chronic-PhaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
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