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Recruiting NCT05943522

Asciminib RMP Study

Conditions: Chronic Myeloid Leukemia

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Asciminib
OTHER
Locations 17
South Korea (17)
Novartis Investigative Site
Anyang-si , Gyeonggi-do
Novartis Investigative Site
Bucheon-si , Gyeonggi-do
Novartis Investigative Site
Gyeonggi-do , Korea
Novartis Investigative Site
Incheon , Korea
Novartis Investigative Site
Jeollanam
Novartis Investigative Site
Pusan
Novartis Investigative Site
Seoul , Korea
Novartis Investigative Site
Seoul , Seoul
Novartis Investigative Site
Seoul , Seoul
Novartis Investigative Site
Seoul , Yangcheon gu
Novartis Investigative Site
Seoul
Novartis Investigative Site
Seoul
Novartis Investigative Site
Seoul
Novartis Investigative Site
Suwon , Yeongtong Gu
Novartis Investigative Site
Taegu
Novartis Investigative Site
Uijeongbu-si , Gyeonggi-do
Novartis Investigative Site
Wŏnju , Gangwon-do
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
19.07.2023
Completion date
07.06.2030
Registry ID
NCT05943522
Source
clinicaltrials.gov
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