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)

Novartis

Status: Completed

Conditions: Chronic Myeloid Leukemia With T315I Mutation

Study type: Observational

Funder types: Industry

Identifiers

NCT06211153

CABL001A2004

Details and patient eligibility

About

This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria

• Age less than 18 years old at the time of initiating asciminib treatment.

Trial design

31 participants in 1 patient group

Asciminib