Asciminib RMP Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Other: Asciminib

Detailed Description

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.

This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• South Korea
  • Jeollanam, South Korea, 519763
    • Recruiting
    • Novartis Investigative Site
  • Pusan, South Korea, 614 735
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 06591
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Novartis Investigative Site
  • Taegu, South Korea, 41944
    • Recruiting
    • Novartis Investigative Site
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Recruiting
      • Novartis Investigative Site
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, South Korea, 14068
      • Recruiting
      • Novartis Investigative Site
    • Bucheon-si, Gyeonggi-do, South Korea, 14584
      • Recruiting
      • Novartis Investigative Site
    • Uijeongbu-si, Gyeonggi-do, South Korea, 11759
      • Recruiting
      • Novartis Investigative Site
  • Korea
    • Gyeonggi-do, Korea, South Korea, 10408
      • Recruiting
      • Novartis Investigative Site
    • Incheon, Korea, South Korea, 405 760
      • Recruiting
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 02841
      • Recruiting
      • Novartis Investigative Site
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Novartis Investigative Site
    • Seoul, Seoul, South Korea, 03080
      • Recruiting
      • Novartis Investigative Site
  • Yangcheon gu
    • Seoul, Yangcheon gu, South Korea, 07985
      • Recruiting
      • Novartis Investigative Site
  • Yeongtong Gu
    • Suwon, Yeongtong Gu, South Korea, 16499
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are going to receive Scemblix® for the first time or those who are currently taking Scemblix® per clinical judgment are eligible and will be prescribed with Scemblix® under routine medical practice.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asciminib; Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice	Other: 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; Other Names: Scemblix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with an AE / ADR	Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)	24 weeks
Percentage of participants with a SAE / SADR	Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)	24 weeks
Percentage of participants with an UAE/ UADR	Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)	24 weeks
Percentage of participants with a SUAE/ SUADR	Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major molecular response rate	Major molecular response (MMR) rate at week 12 and week 24	week 12, week 24
Molecular response 4 rate	Molecular response 4 (MR4) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).	week 12, week 24
Molecular response 4.5 rate	Molecular response 4.5 (MR4.5) rate. Molecular response (MR) is a Breakpoint Cluster Region protein Tyrosine-protein kinase ABL1 (BCR-ABL1) transcript that is assessed by real-time quantitative PCR (RQ-PCR) in the blood at screening. Molecular response levels are indicated with a superscript indicating the log reduction from the standardized baseline, corresponding to 100% on the international scale (IS).	week 12 ,week 24
Number of participants with CCyR and/or BCR-ABL1 IS<1%	Complete cytogenetic response (CCyR) rate and/or BCR-ABL1 IS<1%. A complete cytogenetic response (CCyR) is defined as absence of the Ph (0%) among at least 20 cells in metaphase in a bone marrow aspirate.	week 12,week 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): June 7, 2030
• Study Completion (Estimated): June 7, 2030

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Myeloid Leukemia; CML; Asciminib; Scemblix
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; asciminib
• Other Study ID Numbers: CABL001A2006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO