Clinical trial · Observational
A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
NCT07681258CI-TRIAL-00121146ASC4Youngnot yet recruitingClinicalTrials.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)
The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region. The data source for this study will consist of routinely collected clinical information documented within the electronic health records (EHR) of participating centers.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Young Adults Cohort
- description
- CML patients aged ≤ 40 years at the first documented asciminib administration.
- label
- Older Adults Cohort
- description
- CML patients aged \> 40 years at the first documented asciminib administration.
Primary outcomes (1)
- measure
- Major Molecular Response (MMR) Rate in Young Adults
- timeFrame
- Approximately 12 Months
- description
- MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
Secondary outcomes (19)
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
- Approximately 3, 6, and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria * Confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) * Adult patients aged ≥ 18 years at the index date (or adult as defined by applicable national regulations) * Documented exposure to asciminib during the identification period (May 2023 to May 2026) * Provision of signed informed consent for secondary use of data, or an ethics committee-approved waiver of consent, where applicable (including for deceased patients or where data were previously collected within the EHR system) Exclusion Criteria * Patients who do not meet the eligibility criteria specified above * Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes
References
Publications (0)
Data not yet available
No reference posted for this study.