An observational study in Chronic Myeloid Leukemia With T315I Mutation, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Novartis Pharmaceuticals · Observational
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 31 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study.
Study Population: Key Inclusion/Exclusion Criteria Inclusion criteria
Appropriate approval was obtained for the patient chart review including:
Exclusion criteria
Major molecular response (MMR) at 6 months
Time frame: At 6 months
Major molecular response (MMR) by 6 months
Time frame: By 6 months
MMR at and by 3, 9, and 12 months
Time frame: At and by 3, 9, and 12 months
Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Time to first CCyR at and by 3, 6, 9, and 12 months
Time frame: At and by 3, 6, 9, and 12 months
Gender
Time frame: Baseline
Race
Time frame: Baseline
Time from CML diagnosis to study index (i.e., asciminib) start date
Time frame: Baseline
Country of residence
Time frame: Baseline
Status of CML at baseline
Time frame: Baseline
Number of patients per response type at asciminib start date
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Stem-cell transplant performed status
Time frame: Baseline
Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date
Time frame: Baseline
Overall tyrosine kinase inhibitors (TKIs) prior to index date
Time frame: Baseline
Prior TKIs between CML diagnosis and T315I mutation diagnosis
Time frame: Baseline
Prior TKIs between T315I mutation diagnosis and index date
Time frame: Baseline
Sequence of prior TKI treatment patterns
Time frame: Baseline
Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)
Response types were MMR, CCyR, and CHR.
Time frame: Baseline
Number of patients with intolerance to prior TKIs, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Time frame: Baseline
Number of patients with intolerance to last TKI prior to asciminib, per category
Categories were discontinuation due to adverse events, relationship to treatment, and outcome.
Time frame: Baseline
Asciminib dose
Time frame: Up to 13 months
Asciminib discontinuation
Time frame: Up to 13 months
Duration of exposure to asciminib
Time frame: Up to 13 months
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals