Clinical trial · Observational
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
Scemblix® (Asciminib): Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML-CP in Real World Setting in France
NCT06092879CI-TRIAL-00112922ASSURE-3active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asciminib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Asciminib
- description
- Adult patients with Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors
- interventionNames
- Other: Asciminib
Primary outcomes (1)
- measure
- Proportion of patients remaining on asciminib at 12 months
- timeFrame
- Month 12
- description
- Proportion of patients remaining on asciminib treatment at 12 months to be provided
Secondary outcomes (17)
- measure
- Proportion of patients in major molecular response (MMR) - for patients not in MMR at treatment initiation
- timeFrame
- 12 months
- description
- Molecular response to treatment: Response to treatment (MMR, BCR::ABL1 ≤ 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients not in MMR at treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient aged ≥ 18 years at inclusion, 2. Patient with Ph+ CML-CP previously treated with two or more TKIs, 3. 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, 4. Patient having given their non objection to participate to the study Exclusion Criteria: 1. Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment, 2. Patient with known history of T315I mutation, 3. Patient who previously received asciminib treatment, 4. Patient currently participating to an interventional clinical trial, 5. Patient with known contra-indication to asciminib according to the SmPC.
References
Publications (0)
Data not yet available
No reference posted for this study.