Clinical trial Recruiting at 17 sites Observational Ages 18 to 100

Observational study of Asciminib in patients with Chronic Myeloid Leukemia

Official title: A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea

Run by Novartis · NCT05943522 · Data updated 2026-11-12

This study is looking at how well Asciminib works and how safe it is for adults with Chronic Myeloid Leukemia in Korea who are using this medication as prescribed by their doctors.

More Chronic Myeloid Leukemia trials

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment600 (estimated)
SponsorNovartis
Industry-sponsored
Drugs / interventionsAsciminib
Locations17 sites (Wŏnju, Gangwon-do and 16 other locations)
StatusRecruiting
StartedJuly 19, 2023
Main results expectedJune 7, 2030
Study endsJune 7, 2030
Registry record updatedApril 20, 2026
Trial IDNCT05943522 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adult patients diagnosed with Ph+ CP-CML who are currently receiving or will receive Asciminib treatment.

Probably not a fit

Patients with contraindications to Asciminib or those receiving investigational medicines during the observation period may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and effectiveness of Asciminib in real-world clinical settings for patients with Chronic Myeloid Leukemia (CML) in Korea. It will enroll adult patients diagnosed with Ph+ CP-CML who are prescribed Asciminib at the discretion of their physicians. The study will follow these patients for two years after the market launch of the medication, allowing for a comprehensive evaluation of treatment outcomes. The dosage and duration of treatment will be determined by the investigator based on the prescribing information.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Asciminib for CML patients.

How similar studies have gone: Other studies have shown success with similar observational approaches in assessing real-world treatment outcomes for CML.

Who can join: the full rules

Show full inclusion / 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

Where it's running

  • Novartis Investigative Site
    Wŏnju, Gangwon-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Anyang-si, Gyeonggi-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Bucheon-si, Gyeonggi-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Uijeongbu-si, Gyeonggi-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Gyeonggi-do, Korea, South Korea
    Recruiting
  • Novartis Investigative Site
    Incheon, Korea, South Korea
    Recruiting
Show 11 more locations
  • Novartis Investigative Site
    Seoul, Korea, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Yangcheon gu, South Korea
    Recruiting
  • Novartis Investigative Site
    Suwon, Yeongtong Gu, South Korea
    Recruiting
  • Novartis Investigative Site
    Jeollanam, South Korea
    Recruiting
  • Novartis Investigative Site
    Pusan, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Taegu, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Potential of asciminib in early chronic‑phase CML

    This trial will see if asciminib alone, or asciminib plus nilotinib, helps adults newly diagnosed with chronic‑phase, BCR‑ABL–positive CML reach deep molecular responses and remain off treatment.

    Recruiting at 11 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Barcelona and 10 other locations · NCT06409936

  • Evaluating asciminib for newly diagnosed chronic myeloid leukemia patients

    This study is testing a new drug called asciminib to see if it helps people with newly diagnosed chronic myeloid leukemia feel better and achieve a good response to treatment after a year.

    Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06236724

  • Asciminib for chronic phase CML with T315I mutation

    This study tests asciminib 200 mg twice daily in adults with chronic phase CML and a T315I mutation after stem cell transplant to see if it helps control leukemia.

    Recruiting at 5 sites Phase 2 University of Jena · Aachen and 9 other locations · NCT07789574

  • Asciminib for Ph+ CML-CP in Germany: real-world patient experiences

    This real-world study tests how asciminib performs in adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, including those newly diagnosed or after one prior TKI.

    Recruiting at 74 sites Novartis · Baden-Baden, Baden-Wurttemberg and 73 other locations · NCT07549516

  • Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

    This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

    Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

  • Scemblix (asciminib) for newly diagnosed chronic-phase CML in China

    This project will try asciminib (Scemblix) in adults newly diagnosed with chronic-phase CML to see if it controls the disease and is safe.

    Recruiting Novartis · Wuhan, Hubei · NCT07375355

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.