Clinical trial NCT05943522: Asciminib RMP Study
Official title: A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myeloid Leukemia
Keywords: Scemblix
Asciminib
CML
Chronic Myeloid Leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Percentage of participants with an AE / ADR
timeFrame: 24 weeks
measure: Percentage of participants with a SAE / SADR
timeFrame: 24 weeks
measure: Percentage of participants with an UAE/ UADR
timeFrame: 24 weeks
measure: Percentage of participants with a SUAE/ SUADR
timeFrame: 24 weeks
Secondary outcomes:
measure: Major molecular response rate
timeFrame: week 12, week 24
measure: Molecular response 4 rate
timeFrame: week 12, week 24
measure: Molecular response 4.5 rate
timeFrame: week 12 ,week 24
measure: Number of participants with CCyR and/or BCR-ABL1 IS<1%
timeFrame: week 12,week 24
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-do
city: Uijeongbu si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Gyeonggi do
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeollanam
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taegu
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: