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Clinical Trials in South Korea / NCT05943522
Recruiting Observational

Asciminib RMP Study

NCT05943522 · tracked via the Priya Life Science South Korea tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2023-07-19
Last updated
2026-04-20

Condition(s) studied

Chronic Myeloid Leukemia

Investigational drug(s) / intervention(s)

Asciminib

Asciminib: There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 outcome measure(s)

  • Percentage of participants with an AE / ADR — 24 weeks
    Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
  • Percentage of participants with a SAE / SADR — 24 weeks
    Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
  • Percentage of participants with an UAE/ UADR — 24 weeks
    Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
  • Percentage of participants with a SUAE/ SUADR — 24 weeks
    Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)

Trial sites (17)

FacilityCityRegionStatus
Novartis Investigative Site Wŏnju Gangwon-do Recruiting
Novartis Investigative Site Anyang-si Gyeonggi-do Recruiting
Novartis Investigative Site Bucheon-si Gyeonggi-do Recruiting
Novartis Investigative Site Uijeongbu-si Gyeonggi-do Recruiting
Novartis Investigative Site Gyeonggi-do Korea Recruiting
Novartis Investigative Site Incheon Korea Recruiting
Novartis Investigative Site Seoul Korea Recruiting
Novartis Investigative Site Seoul Seoul Recruiting
Novartis Investigative Site Seoul Seoul Recruiting
Novartis Investigative Site Seoul Yangcheon gu Recruiting
Novartis Investigative Site Suwon Yeongtong Gu 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

More Novartis Pharmaceuticals trials in South Korea

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A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting

Other trials for the same condition

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) Recruiting
Study of Olverembatinib (HQP1351) in Patients With CML-CP Recruiting
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05943522 on ClinicalTrials.gov ↗ ← All trials in South Korea