Status:
ACTIVE_NOT_RECRUITING
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-99 years
Brief Summary
The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients trea...
Detailed Description
The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in real-life conditions with primary data collection in adult patients with Philadelphia chromosome-positive chron...
Eligibility Criteria
Inclusion
- Patient aged ≥ 18 years at inclusion,
- Patient with Ph+ CML-CP previously treated with two or more TKIs,
- Patient for whom a decision has been taken by the treating physician (investigator) to initiate treatment with asciminib according to his own practice, the drug label / Summary of Product Characteristics (SmPC), and regardless of study participation,
- Patient having given their non objection to participate to the study
Exclusion
- Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
- Patient with known history of T315I mutation,
- Patient who previously received asciminib treatment,
- Patient currently participating to an interventional clinical trial,
- Patient with known contra-indication to asciminib according to the SmPC.
Key Trial Info
Start Date :
March 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2026
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT06092879
Start Date
March 6 2024
End Date
December 15 2026
Last Update
December 22 2025
Active Locations (59)
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1
Novartis Investigative Site
Angers, France, France, 49933
2
Novartis Investigative Site
Challes-les-Eaux, France, France, 73190
3
Novartis Investigative Site
Limoges, Haute Vienne, France, 87000
4
Novartis Investigative Site
Saint Priest Jarez, Pays de la Loire Region, France, 42270