Actively Recruiting

Age: 18Years - 100Years
All Genders
ID05943522

A Post Approval Surveillance of Scemblix4 (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea

Led by Novartis Pharmaceuticals · Updated on 2026-04-20

600

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Asciminib in Korean patients with Chronic Myeloid Leukemia (CML) in a prospective, open-label, multi-center observational study. The study focuses on understanding how Asciminib works in real-world clinical settings following its market approval, enrolling patients treated under usual clinical practice. Participants prescribed Asciminib by their physicians according to the locally approved label will be included in this study. The dosage and duration of Asciminib treatment will be decided by the investigators based on prescribing information. The study plans to enroll all patients prescribed Asciminib for two years after its market launch. During the study, researchers will monitor participants for adverse events and various molecular response rates at 12 and 24 weeks. Data on safety, including serious and unexpected adverse reactions, will be collected. Participants will be followed during their usual care, and no study drug will be dispensed by the sponsor. The total participation duration depends on clinical practice and monitoring schedules.

CONDITIONS

Brief Title

Asciminib RMP Study

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix4 treatment according to locally approved label
  • Patients who are willing to provide written informed consent prior to study enrollment
Not Eligible

You will not qualify if you...

  • Patients with contraindication according to locally approved label of Scemblix4
  • Patients who receive or are going to receive any investigational medicine during the observation period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants who are prescribed Asciminib at physicians' discretion are observed under usual clinical practice for 2 years after market launch.

Visits as per routine clinical practice

Trial Site Locations

Total: 17 locations

1

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea, 26426

Actively Recruiting

2

Novartis Investigative Site

Anyang-si, Gyeonggi-do, South Korea, 14068

Actively Recruiting

3

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea, 14584

Actively Recruiting

4

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, South Korea, 11759

Actively Recruiting

5

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea, 10408

Actively Recruiting

6

Novartis Investigative Site

Incheon, Korea, South Korea, 405 760

Actively Recruiting

7

Novartis Investigative Site

Seoul, Korea, South Korea, 02841

Actively Recruiting

8

Novartis Investigative Site

Seoul, Seoul, South Korea, 03080

Actively Recruiting

9

Novartis Investigative Site

Seoul, Seoul, South Korea, 06351

Actively Recruiting

10

Novartis Investigative Site

Seoul, Yangcheon gu, South Korea, 07985

Actively Recruiting

11

Novartis Investigative Site

Suwon, Yeongtong Gu, South Korea, 16499

Actively Recruiting

12

Novartis Investigative Site

Jeollanam, South Korea, 519763

Actively Recruiting

13

Novartis Investigative Site

Pusan, South Korea, 614 735

Actively Recruiting

14

Novartis Investigative Site

Seoul, South Korea, 03722

Actively Recruiting

15

Novartis Investigative Site

Seoul, South Korea, 05505

Actively Recruiting

16

Novartis Investigative Site

Seoul, South Korea, 06591

Actively Recruiting

17

Novartis Investigative Site

Taegu, South Korea, 41944

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

N

Novartis Pharmaceuticals

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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