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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | Asciminib |
| Locations | 17 sites (Wŏnju, Gangwon-do and 16 other locations) |
| Status | Recruiting |
| Started | July 19, 2023 |
| Main results expected | June 7, 2030 |
| Study ends | June 7, 2030 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT05943522 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
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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
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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
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.
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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.
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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.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.