CML ADVOCATES NETWORK

Clinical Trials

CABL001A2006 = Asciminib RMP Study [Korea]

Study title

Asciminib RMP Study

Scientific title

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

Type of study

Observational study

Phase

Observational study

Current status

Recruiting

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Other trial ID

ClinicalTrials.gov NCT05943522

What is the purpose of the study

This is an observational study to assess the safety and effectiveness of asciminib in real-world management of Korean patients with chronic myeloid leukemia in chronic phase.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older.
  • have been newly diagnosed with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) and currently receiving or going to receive Scemblix® treatment according to locally approval label.
  • are willing to provide written informed consent prior to study enrollment.

Further criteria may apply. Please discuss these with your doctor or study staff.

 

Key exclusion criteria

This study does not include patients who:

  • meet any of the contraindications to the administration of the study drug according to the locally approved label of Scemblix®.
  • receive or are going to receive any investigational medicine during the observation period.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

July 2025

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.
You can also find a study description on the website of Novartis.

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Study Director:Novartis Pharmaceuticals

Study centers / principal investigators

Korea, Republic of

Novartis Investigative Site
Jeollanam, 519763

Novartis Investigative Site
Pusan, 614 735

Novartis Investigative Site
Seoul, 02841

Novartis Investigative Site
Seoul, 03080

Novartis Investigative Site
Seoul, 03722

Novartis Investigative Site
Seoul, 05505

Novartis Investigative Site
Seoul, 158-710

Novartis Investigative Site
Taegu, 41944

Novartis Investigative Site
Wonju-si, Gangwon-do, 26426

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759

Novartis Investigative Site
Seoul, Seocho Gu, 06591