Asciminib RMP Study

Novartis

Status: Enrolling

Conditions: Chronic Myeloid Leukemia

Treatments: Other: Asciminib

Study type: Observational

Funder types: Industry

Identifiers

NCT05943522

CABL001A2006

Details and patient eligibility

About

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.

Full description

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.

This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion criteria

1. Patients with contraindication according to locally approved label of Scemblix®
2. Patients who receive or are going to receive any investigational medicine during the observation period

Trial design

100 participants in 1 patient group

Asciminib

Description:

Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice

Treatment:

Other: Asciminib