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NCT Number: NCT07681258

A 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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Approximately 3, 6, and 12 months

  2. 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.

  3. Incidence of AEs Leading to Dose Modifications

    Time frame: Approximately 3, 6, and 12 months

    Dose modifications include treatment interruptions and dose reductions.

  4. Number of Treatment Interruptions Due to AEs

    Time frame: Approximately 3, 6, and 12 months

  5. Duration of Treatment Interruptions Due to AEs

    Time frame: Approximately 3, 6, and 12 months

  6. Time to Treatment Discontinuation due to Adverse Events (TTDAE)

    Time frame: Approximately 3, 6, and 12 months

  7. Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 10% After 3 Months of Treatment

    Time frame: 3 months

  8. Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment

    Time frame: 6 months

  9. MMR in Patients Aged > 40 years

    Time frame: Approximately 12 months

    MMR is defined as BCR::ABL1 IS ≤ 0.1%.

  10. 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.

  11. Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment

    Time frame: Up to 12 months prior to Baseline

  12. Duration of CML at Time of Asciminib Treatment Initiation

    Time frame: Baseline

  13. Asciminib Starting Dose

    Time frame: Baseline

  14. 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.

  15. Number of Treatment Interruptions

    Time frame: Approximately 3, 6, and 12 months

  16. Duration of Treatment Interruptions

    Time frame: Approximately 3, 6, and 12 months

  17. Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching

    Time frame: Approximately 3, 6, and 12 months

  18. Number of Patients by Reason for Treatment Switch

    Time frame: Approximately 3, 6, and 12 months

  19. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region

Acronym: ASC4Young

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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