Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Treatment

NCT07188428 | Completed

• 1 other identifier: CABL001A0US06
• Study Type: observational
• Target: 2,298
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the real-world treatment patterns, healthcare resource use and costs among patients newly diagnosed with CML who were treated with tyrosine kinase inhibitors (TKIs) in first- and second-line therapy.

Conditions

Leukemia, Chronic Myeloid

Keywords

Tyrosine kinase inhibitors; Treatment pattern; Non-optimal treatment profile

Outcome Measures

Primary Outcomes (3)

• Number of Patients Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile

  Up to approximately 6 years

• Number of Patients Who Switched to Another CML-related Treatment Within 6 Months of Starting Treatment by TKI Generation and Treatment Profile

  6 months

• Time to Treatment Switch by TKI Generation and Treatment Profile

  Up to approximately 6 years

Secondary Outcomes (13)

• Proportion of Days Covered (PDC) by TKI Generation and Treatment Profile

  Up to approximately 6 years

• Number of Patients With PDC >80% by TKI Generation and Treatment Profile

  Up to approximately 6 years

• Number of Patients who Discontinued Treatment by TKI Generation and Treatment Profile

  Up to approximately 6 years

• Time to Treatment Discontinuation by TKI Generation and Treatment Profile

  Up to approximately 6 years

• Number of Patients With Treatment Interruption by TKI Generation and Treatment Profile

  Up to approximately 6 years

Study Arms (2)

1L Cohort

Adult patients newly diagnosed with CML who received 1L treatment with imatinib, dasatinib, nilotinib, or bosutinib.

2L Cohort

Adult patients from the 1L Cohort with a subsequent line of treatment (i.e., second treatment) with imatinib, dasatinib, nilotinib, bosutinib, ponatinib, or asciminib.

Eligibility Criteria

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

Study Population

This was a retrospective, non-interventional cohort study.

You may qualify if:

• L Cohort:
• Patients had at least one diagnosis for CML (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\]: C92.1x) during the observation period.
• Patients ≥18 years of age as of the first CML diagnosis.
• Patients received imatinib, dasatinib, nilotinib, or bosutinib in 1L.
• Patients initiated 1L within a maximum of 3 months following the first observed CML diagnosis.
• Patients had at least 12 months of continuous enrollment prior to the index date.
• Patients had at least 6 months of continuous enrollment post index date (including index date).
• L Cohort:
• Patients in the 1L cohort.
• Patients received imatinib, dasatinib, nilotinib, bosutinib, ponatinib or asciminib in 2L.
• Patients with at least 12 months of continuous enrollment prior to the index date.
• Patients with at least 6 months of continuous enrollment post index date (including index date).

You may not qualify if:

• L Cohort:
• Patients with medical services with a procedure code for imatinib any time during the observation period.
• Patients with a diagnosis for CML remission (identified by ICD-10-CM code: C92.11) or CML relapse (ICD-10-CM code: C92.12) any time in the baseline period before the 1L initiation.
• Patients with a medical claim associated with a clinical trial drug during the baseline period before the 1L initiation up to the end of the observation period.
• Patients who received chemotherapy, or a TKI of interest or had a hematopoietic stem cell transplantation (HSCT) during the baseline period before 1L initiation.
• L Cohort:
• Patients with a diagnosis for CML remission (identified by ICD-10-CM code: C92.11) or CML relapse (ICD-10-CM code: C92.12) any time before the 2L initiation.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

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

Study Design

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

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: February 27, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)