Chronic Myeloid LeukemiaASC4YoungNCT07681258
A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2026to 30 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.
Who may be able to join
- 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)
Who cannot join
- Patients who do not meet the eligibility criteria specified above
- Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
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
- Chronic Myeloid Leukemia
- Keywords
- Asciminib, Chronic Myeloid Leukemia, Young Adults, Real-world Evidence, Efficacy and Safety, Major Molecular Response, Unmet Medical Need, Gulf Region
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
Major Molecular Response (MMR) Rate in Young Adults
MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
Measured: Approximately 12 Months
Secondary outcomes (19)
Incidence of Adverse Events (AEs)
Measured: Approximately 3, 6, and 12 months
Number of Patients by Type and Severity of AEs
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.
Measured: Approximately 3, 6, and 12 months
Incidence of AEs Leading to Dose Modifications
Dose modifications include treatment interruptions and dose reductions.
Measured: Approximately 3, 6, and 12 months
Number of Treatment Interruptions Due to AEs
Measured: Approximately 3, 6, and 12 months
Duration of Treatment Interruptions Due to AEs
Measured: Approximately 3, 6, and 12 months
Time to Treatment Discontinuation due to Adverse Events (TTDAE)
Measured: Approximately 3, 6, and 12 months
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 10% After 3 Months of Treatment
Measured: 3 months
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment
Measured: 6 months
MMR in Patients Aged > 40 years
MMR is defined as BCR::ABL1 IS ≤ 0.1%.
Measured: Approximately 12 months
Rate of Deep Molecular Response
Deep molecular response includes:
- Molecular response (MR) 4.0 (BCR::ABL1 IS ≤ 0.01%), and
- MR4.5 (BCR::ABL1 IS ≤ 0.0032%), where available.
Measured: Approximately 12 months
Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment
Measured: Up to 12 months prior to Baseline
Duration of CML at Time of Asciminib Treatment Initiation
Measured: Baseline
Asciminib Starting Dose
Measured: Baseline
Number of Patients With Dose Modifications
Number of patients with dose modifications including up titration or dose reduction.
Measured: Approximately 3, 6, and 12 months
Number of Treatment Interruptions
Measured: Approximately 3, 6, and 12 months
Duration of Treatment Interruptions
Measured: Approximately 3, 6, and 12 months
Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching
Measured: Approximately 3, 6, and 12 months
Number of Patients by Reason for Treatment Switch
Measured: Approximately 3, 6, and 12 months
Number of Patients by Clinicopathological Characteristics
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)
Measured: Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start29 Oct 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681258
- Sponsor's protocol ID
- CABL001J1AE01
- Acronym
- ASC4Young
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Individual data sharing
- No