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

NCT07454850 | Not Yet Recruiting

• 1 other identifier: CABL001AKW01
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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: * 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)

  Baseline

Secondary Outcomes (26)

• Number and Percentage of Patients by TKI and Line of Therapy

  Up to approximately 10 years

• Time-to-Treatment

  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

Study Arms (1)

CML Cohort

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

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share