A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
Chronic Myeloid Leukemia
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 99 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 80 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Study population
CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Young Adults Cohort
CML patients aged ≤ 40 years at the first documented asciminib administration.
Older Adults Cohort
CML patients aged \> 40 years at the first documented asciminib administration.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Major Molecular Response (MMR) Rate in Young Adults
Time frame: Approximately 12 Months
MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
Secondary measures
Incidence of Adverse Events (AEs)
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Number of Patients by Type and Severity of AEs
Time frame: Approximately 3, 6, and 12 months
Number of patients by type and severity of AEs including serious AEs and grade ≥ 3 AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Incidence of AEs Leading to Dose Modifications
Time frame: Approximately 3, 6, and 12 months
Dose modifications include treatment interruptions and dose reductions.
Number of Treatment Interruptions Due to AEs
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Duration of Treatment Interruptions Due to AEs
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Time to Treatment Discontinuation due to Adverse Events (TTDAE)
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 10% After 3 Months of Treatment
Time frame: 3 months
Not reported in this registry record.
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment
Time frame: 6 months
Not reported in this registry record.
MMR in Patients Aged > 40 years
Time frame: Approximately 12 months
MMR is defined as BCR::ABL1 IS ≤ 0.1%.
Rate of Deep Molecular Response
Time frame: Approximately 12 months
Deep molecular response includes:
- Molecular response (MR) 4.0 (BCR::ABL1 IS ≤ 0.01%), and
- MR4.5 (BCR::ABL1 IS ≤ 0.0032%), where available.
Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment
Time frame: Up to 12 months prior to Baseline
Not reported in this registry record.
Duration of CML at Time of Asciminib Treatment Initiation
Time frame: Baseline
Not reported in this registry record.
Asciminib Starting Dose
Time frame: Baseline
Not reported in this registry record.
Number of Patients With Dose Modifications
Time frame: Approximately 3, 6, and 12 months
Number of patients with dose modifications including up titration or dose reduction.
Number of Treatment Interruptions
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Duration of Treatment Interruptions
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Number of Patients by Reason for Treatment Switch
Time frame: Approximately 3, 6, and 12 months
Not reported in this registry record.
Number of Patients by Clinicopathological Characteristics
Time frame: Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline
Clinicopathological characteristics include:
- Demographics (gender, ethnicity, nationality, smoking status, and insurance status)
- Clinical presentation (signs and symptoms of disease)
- Laboratory parameters (lipid panel, complete blood count, clinical chemistry, kidney, liver and pancreas function tests)
- Molecular findings (BCR::ABL1 transcript types, additional cytogenetic abnormalities, and other reported mutations)
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Novartis Pharmaceuticals
- Study start
- Dec 1, 2026 Estimated
- Primary completion
- Sep 1, 2027 Estimated
- Study completion
- Sep 1, 2027 Estimated
- First posted
- Jul 2, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026