Asciminib RMP Study

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943522
• Other study ID #: CABL001A2006
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Gyeonggi do	Korea
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jeollanam
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Taegu
Korea, Republic of	Novartis Investigative Site	Uijeongbu si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Wonju-si	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with an AE / ADR	Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)	24 weeks
Primary	Percentage of participants with a SAE / SADR	Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)	24 weeks
Primary	Percentage of participants with an UAE/ UADR	Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)	24 weeks
Primary	Percentage of participants with a SUAE/ SUADR	Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)	24 weeks
Secondary	Major molecular response rate	Major molecular response (MMR) rate at week 12 and week 24	week 12, week 24
Secondary	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
Secondary	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
Secondary	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