Chronic Myeloid Leukemia With T315I Mutation
Conditions
Brief summary
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major molecular response (MMR) at 6 months | At 6 months |
| Major molecular response (MMR) by 6 months | By 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients per response type at asciminib start date | Baseline | Response types were MMR, CCyR, and CHR. |
| 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 | — |
| 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 | — |
| 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 | — |
| Stem-cell transplant performed status | 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) | Baseline | Response types were MMR, CCyR, and CHR. |
| 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. |
| Number of patients with intolerance to prior TKIs, per category | Baseline | Categories were discontinuation due to adverse events, relationship to treatment, and outcome. |
| 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 dose | Up to 13 months | — |
| Asciminib discontinuation | Up to 13 months | — |
| Duration of exposure to asciminib | Up to 13 months | — |
| Prior TKIs between CML diagnosis and T315I mutation diagnosis | Baseline | — |
| Status of CML at baseline | Baseline | — |
Countries
Switzerland
Outcome results
None listed