Asciminib RMP Study

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05943522

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

Major molecular response rate [week 12, week 24]
Major molecular response (MMR) rate at week 12 and week 24
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).
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
Patients who are willing to provide written informed consent prior to study enrollment

Exclusion criteria

Patients with contraindication according to locally approved label of Scemblix®
Patients who receive or are going to receive any investigational medicine during the observation period