A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region

NCT07681258 | Not Yet Recruiting

• 1 other identifier: CABL001J1AE01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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%.

  Approximately 12 Months

Secondary Outcomes (19)

• Incidence of Adverse Events (AEs)

  Approximately 3, 6, and 12 months

• Number of Patients by Type and Severity of AEs

  Approximately 3, 6, and 12 months

• Incidence of AEs Leading to Dose Modifications

  Approximately 3, 6, and 12 months

• Number of Treatment Interruptions Due to AEs

  Approximately 3, 6, and 12 months

• Duration of Treatment Interruptions Due to AEs

  Approximately 3, 6, and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.

You may qualify if:

• 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)

You may not qualify if:

• Patients who do not meet the eligibility criteria specified above
• Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share