Asciminib RMP Study

Recruiting

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT05943522
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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 Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-13
• Study Start: 2023-07-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 an AE / ADR	24 weeks	Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
Percentage of participants with a SUAE/ SUADR	24 weeks	Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)

Secondary Outcome Measures

Name	Time	Method
Major molecular response rate	week 12, week 24	Major molecular response (MMR) rate at week 12 and week 24
Molecular response 4.5 rate	week 12 ,week 24	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).
Molecular response 4 rate	week 12, week 24	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).
Number of participants with CCyR and/or BCR-ABL1 IS<1%	week 12,week 24	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Taegu, Korea, Republic of

Novartis Investigative Site

🇰🇷Taegu, Korea, Republic of