Clinical trial · Observational
Asciminib RMP Study
A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
NCT05943522CI-TRIAL-00108794recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asciminib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Asciminib
- description
- Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice
- interventionNames
- Other: Asciminib
Primary outcomes (4)
- measure
- Percentage of participants with an AE / ADR
- timeFrame
- 24 weeks
- description
- Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
- measure
- Percentage of participants with a SAE / SADR
- timeFrame
- 24 weeks
- description
- Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.