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Recruiting NCT05943522

Asciminib RMP Study

— Observational Chronic Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Asciminib.
Who it may be relevant to
Registry conditions: Chronic Myeloid Leukemia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Percentage of participants with an AE / ADR [Time frame: 24 weeks]
  • Percentage of participants with a SAE / SADR [Time frame: 24 weeks]
  • Percentage of participants with an UAE/ UADR [Time frame: 24 weeks]
  • Percentage of participants with a SUAE/ SUADR [Time frame: 24 weeks]
Secondary outcome measures (4)
  • Major molecular response rate [Time frame: week 12, week 24]
  • Molecular response 4 rate [Time frame: week 12, week 24]
  • Molecular response 4.5 rate [Time frame: week 12 ,week 24]
  • Number of participants with CCyR and/or BCR-ABL1 IS<1% [Time frame: week 12,week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 17 centers
  • Novartis Investigative Site — Wŏnju
  • Novartis Investigative Site — Anyang-si
  • Novartis Investigative Site — Bucheon-si
  • Novartis Investigative Site — Uijeongbu-si
  • Novartis Investigative Site — Gyeonggi-do
  • Novartis Investigative Site — Incheon
  • Novartis Investigative Site — Seoul
  • Novartis Investigative Site — Seoul
  • … and 9 more centers

Identifiers

NCT: NCT05943522 · CABL001A2006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗