Clinical trial · Observational
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)
NCT06211153CI-TRIAL-00073072completedClinicalTrials.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)
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
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 With T315I Mutation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Asciminib
Primary outcomes (2)
- measure
- Major molecular response (MMR) at 6 months
- timeFrame
- At 6 months
- measure
- Major molecular response (MMR) by 6 months
- timeFrame
- By 6 months
Secondary outcomes (24)
- measure
- MMR at and by 3, 9, and 12 months
- timeFrame
- At and by 3, 9, and 12 months
- measure
- Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months
- timeFrame
- At and by 3, 6, 9, and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.