Trial Title:
Asciminib RMP Study
NCT ID:
NCT05943522
Condition:
Chronic Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Asciminib
Conditions: Keywords:
Scemblix
Asciminib
CML
Chronic Myeloid Leukemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Asciminib
Description:
There is no treatment allocation. Asciminib will be prescribed by the physician as per
locally approved label. No drug will be dispensed from Novartis
Arm group label:
Asciminib
Other name:
Scemblix
Summary:
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Patients who are going to receive Scemblix® for the first time or those who are currently
taking Scemblix® per clinical judgment are eligible and will be prescribed with Scemblix®
under routine medical practice.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Wonju-si
Zip:
26426
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Uijeongbu si
Zip:
11759
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Gyeonggi do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Incheon
Zip:
405 760
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Jeollanam
Zip:
519763
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Pusan
Zip:
614 735
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
158-710
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Taegu
Zip:
41944
Country:
Korea, Republic of
Status:
Recruiting
Start date:
July 19, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943522
