Status:
COMPLETED
A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myeloid Leukemia, Chronic
Eligibility:
All Genders
15+ years
Brief Summary
The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan. This was a retrospecti...
Eligibility Criteria
Inclusion
- Patients who met all the below inclusion criteria and none of the exclusion criteria were included in the study.
- Inclusion criteria:
- Patients who had at least one TKI prescription during the selection period,
- a confirmed diagnosis of chronic phase CML recorded before or at the index date,
- were aged 15 years or older at the index date, and
- had at least 12-months continuous pre-index period.
- Exclusion criteria:
- Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment \[LoT\]),
- a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date,
- a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date,
- a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date,
- a stem cell transplant procedure recorded during the pre-index period.
Exclusion
Key Trial Info
Start Date :
July 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT07150793
Start Date
July 5 2022
End Date
February 8 2023
Last Update
September 2 2025
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936