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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Young Adults Cohort
Group B: Older Adults Cohort

Trial outcomes

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%.

Time frame
Approximately 12 Months

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

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.

Time frame
Approximately 3, 6, and 12 months
3

Incidence of AEs Leading to Dose Modifications

Dose modifications include treatment interruptions and dose reductions.

Time frame
Approximately 3, 6, and 12 months
4

Number of Treatment Interruptions Due to AEs

Time frame
Approximately 3, 6, and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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