Status:
COMPLETED
Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib
Lead Sponsor:
Novartis
Conditions:
Chronic Myeloid Leukemia, Chronic Phase
Eligibility:
All Genders
18+ years
Brief Summary
A retrospective, non-interventional cohort study design using data obtained from the Flatiron Health oncology electronic health record (EHR)-derived de-identified database, was used to address the stu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients who initiated asciminib as identified by Flatiron through the Flatiron Health-Novartis Scemblix CML Spotlight database study.
- Patients had at least one diagnosis for CML (International Classification of Diseases, 9th Edition, Clinical Modification \[ICD-9-CM\]: 205.1x; International Classification of Diseases, 10th Edition, Clinical Modification \[ICD-10-CM\]: C92.1x).
- Diagnosed with CP as identified by Flatiron through chart abstraction.
- Had 2 or more documented clinical visits, on different days in the Flatiron data on or after 1 January 2011.
- Had evidence of treatment with asciminib on or after Food and Drug Administration (FDA) approval date (29 October 2021), with data granularity availability at least at the month level for dates of asciminib use.
- Had CML initial diagnosis date on or after 1 January 2011.
- Had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.).
- Exclusion criteria:
- Patients who did not meet inclusion criteria listed above.
- Had stem-cell transplant (SCT) on or prior to asciminib initiation or unknown SCT date.
- Diagnosed with CML in accelerated phase (AP) or blast crisis (BC) before asciminib initiation, as identified by Flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation.
- Patients had received a clinical study drug between 15 November 2017 and 4 December 2019 (randomization dates for the ASCEMBL trial).
Exclusion
Key Trial Info
Start Date :
April 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06516029
Start Date
April 21 2023
End Date
October 2 2023
Last Update
July 23 2024
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936