Status:
COMPLETED
Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Treatment
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Chronic Myeloid
Eligibility:
All Genders
18+ years
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 (TKI...
Detailed Description
The study used claims from Medicare FFS data from 1 January 2016 to 31 December 2022 (observation period). The patient identification period spanned from 1 January 2017 to 30 June 2022. The index date...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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).
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
February 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
2298 Patients enrolled
Trial Details
Trial ID
NCT07188428
Start Date
February 27 2024
End Date
December 2 2024
Last Update
September 23 2025
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936