Asciminib RMP Study

NCT ID: NCT05943522

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-19

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Asciminib

Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice

Asciminib

Intervention Type OTHER

There is no treatment allocation. Asciminib will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Scemblix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Site Status RECRUITING

Novartis Investigative Site

Incheon, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Jeollanam, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Pusan, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Taegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CABL001A2006

Identifier Type: -

Identifier Source: org_study_id

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