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This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asciminib |
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| Measure | Description | Time Frame |
|---|---|---|
| Major molecular response (MMR) at 6 months | At 6 months | |
| Major molecular response (MMR) by 6 months | By 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MMR at and by 3, 9, and 12 months | At and by 3, 9, and 12 months | |
| Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months | At and by 3, 6, 9, and 12 months | |
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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:
Exclusion criteria
• Age less than 18 years old at the time of initiating asciminib treatment.
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | 4056 | Switzerland |
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| Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months |
| At and by 3, 6, 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 |
| Gender | Baseline |
| Race | Baseline |
| Time from CML diagnosis to study index (i.e., asciminib) start date | Baseline |
| Country of residence | Baseline |
| Status of CML at baseline | Baseline |
| Number of patients per response type at asciminib start date | Response types were MMR, CCyR, and CHR. | Baseline |
| Stem-cell transplant performed status | Baseline |
| Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date | Baseline |
| Overall tyrosine kinase inhibitors (TKIs) prior to index date | Baseline |
| Prior TKIs between CML diagnosis and T315I mutation diagnosis | Baseline |
| Prior TKIs between T315I mutation diagnosis and index date | Baseline |
| Sequence of prior TKI treatment patterns | Baseline |
| Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date) | Response types were MMR, CCyR, and CHR. | Baseline |
| Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis | Response types were MMR, CCyR, and CHR. | 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. | Baseline |
| Number of patients with intolerance to prior TKIs, per category | Categories were discontinuation due to adverse events, relationship to treatment, and outcome. | 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. | Baseline |
| Asciminib dose | Up to 13 months |
| Asciminib discontinuation | Up to 13 months |
| Duration of exposure to asciminib | Up to 13 months |