A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait
Leukemia, Myeloid, Chronic-Phase
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 21 años - 90 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 400 Estimado
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Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Población del estudio
Patients with CML who were treated in a tertiary care center in Kuwait between January 2014 and January 2024.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
CML Cohort
Adult patients diagnosed with CML who received at least one line of TKI treatment between January 2014 and January 2024.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Patients by Demographic Category
Plazo: Baseline
Demographics include gender and ethnicity.
Age at Diagnosis
Plazo: Baseline
No informado en este registro.
Number of Patients by Disease Characteristics at Diagnosis
Plazo: 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)
Medidas secundarias
Number and Percentage of Patients by TKI and Line of Therapy
Plazo: Up to approximately 10 years
No informado en este registro.
Time-to-Treatment
Plazo: 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
Plazo: Up to approximately 10 years
No informado en este registro.
Initial and Maximum TKI Daily Dose
Plazo: Up to approximately 10 years
No informado en este registro.
Number and Percentage of Patients With a Dose Escalation
Plazo: Up to approximately 10 years
No informado en este registro.
Number and Percentage of Patients who Switch TKI Treatment Across All Treatment Lines
Plazo: Up to approximately 10 years
No informado en este registro.
Number of Treatment Modifications by Type of Modification
Plazo: Up to approximately 10 years
Treatment modifications include dose reduction, dose escalation, interruption, and switching.
Number of Treatment Modifications by Reason for Modification
Plazo: 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
Plazo: 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)
Plazo: 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
Plazo: 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)
Plazo: 3, 6, and 12 months
CcyR is defined as the absence of Ph+ve metaphases.
Overall Survival (OS)
Plazo: 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)
Plazo: 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
Plazo: 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
Plazo: Up to approximately 10 years
No informado en este registro.
Percentage of Patients who Die While on TKI Treatment
Plazo: Up to approximately 10 years
No informado en este registro.
Time From Diagnosis to Death
Plazo: Up to approximately 10 years
No informado en este registro.
Time From Initiation of Each Line of TKI Treatment to Death
Plazo: Up to approximately 10 years
No informado en este registro.
Number of Patients by Charlson Comorbidity Index (CCI) Score
Plazo: 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
Plazo: Up to approximately 10 years
No informado en este registro.
Number of Patients by Comorbidity During Each Line of TKI Treatment
Plazo: Up to approximately 10 years
No informado en este registro.
Association Between Comorbidities and Treatment Selection
Plazo: 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
Plazo: 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)
Plazo: 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)
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- Novartis Pharmaceuticals
- Inicio del estudio
- 31 ene 2027 Estimado
- Finalización primaria
- 2 jul 2027 Estimado
- Finalización del estudio
- 2 jul 2027 Estimado
- Primera publicación
- 6 mar 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Retrospective Study on Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia (CML) in Kuwait
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026