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)
Completed
- Conditions
- Chronic Myeloid Leukemia With T315I Mutation
- Registration Number
- NCT06211153
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major molecular response (MMR) by 6 months By 6 months Major molecular response (MMR) at 6 months At 6 months
- Secondary Outcome Measures
Name Time Method MMR at and by 3, 9, and 12 months At and by 3, 9, and 12 months Time to first CCyR at and by 3, 6, 9, and 12 months At and by 3, 6, 9, and 12 months Time from CML diagnosis to study index (i.e., asciminib) start date Baseline Prior TKIs between CML diagnosis and T315I mutation diagnosis Baseline Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months At and by 3, 6, 9, and 12 months Country of residence Baseline Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months At and by 3, 6, 9, and 12 months Gender Baseline Number of patients per response type at asciminib start date Baseline Response types were MMR, CCyR, and CHR.
Overall tyrosine kinase inhibitors (TKIs) prior to index date Baseline Number of patients with intolerance to last TKI prior to asciminib, per category Baseline Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Asciminib discontinuation Up to 13 months Status of CML at baseline Baseline Stem-cell transplant performed status Baseline Race Baseline Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date Baseline Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date) Baseline Response types were MMR, CCyR, and CHR.
Asciminib dose Up to 13 months Duration of exposure to asciminib Up to 13 months Prior TKIs between T315I mutation diagnosis and index date Baseline Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis Baseline Response types were MMR, CCyR, and CHR.
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date) Baseline Response types were MMR, CCyR, and CHR.
Sequence of prior TKI treatment patterns Baseline Number of patients with intolerance to prior TKIs, per category Baseline Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland