Status:
COMPLETED
Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia With T315I Mutation
Eligibility:
All Genders
18+ years
Brief Summary
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
Eligibility Criteria
Inclusion
- Study Population: Key Inclusion/Exclusion Criteria Inclusion criteria
- Diagnosis of CML (chronic phase, accelerated phase or blast crisis).
- Confirmed presence of T315I mutation prior to asciminib initiation.
- Patients enrolled in the asciminib MAP and received their first dose of asciminib between 01 November 2018 and 30 April 2022. Patients must have received at least one dose of asciminib.
- Appropriate approval was obtained for the patient chart review including:
- Patient signed the informed consent form (ICF) or,
- Individual ICF waiver was granted by an institutional review board/ Independent Ethics Committee (IRB)/ IEC.
- Exclusion criteria
- • Age less than 18 years old at the time of initiating asciminib treatment.
Exclusion
Key Trial Info
Start Date :
December 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06211153
Start Date
December 31 2021
End Date
December 15 2022
Last Update
January 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis
Basel, Switzerland, 4056