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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CML Cohort | Adult patients diagnosed with CML who received at least one line of TKI treatment between January 2014 and January 2024. |
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| 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:
| Baseline |
| 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. |
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Inclusion criteria
Exclusion criteria
• Patients not fulfilling any of the above-mentioned inclusion criteria.
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Patients with CML who were treated in a tertiary care center in Kuwait between January 2014 and January 2024.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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:
| 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 |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |