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NCT Number: NCT05943522

Asciminib RMP Study

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asciminib

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

Other names: Scemblix

Primary outcomes

  1. Percentage of participants with an AE / ADR

    Time frame: 24 weeks

    Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)

  2. Percentage of participants with a SAE / SADR

    Time frame: 24 weeks

    Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)

  3. Percentage of participants with an UAE/ UADR

    Time frame: 24 weeks

    Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)

  4. Percentage of participants with a SUAE/ SUADR

    Time frame: 24 weeks

    Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)

Secondary outcomes

  1. Major molecular response rate

    Time frame: week 12, week 24

    Major molecular response (MMR) rate at week 12 and week 24

  2. Molecular response 4 rate

    Time frame: 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).

  3. Molecular response 4.5 rate

    Time frame: 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).

  4. Number of participants with CCyR and/or BCR-ABL1 IS<1%

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 13, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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