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.
Study Type
OBSERVATIONAL
Enrollment
80
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
Incidence of Adverse Events (AEs)
Time frame: 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.
Time frame: Approximately 3, 6, and 12 months
Incidence of AEs Leading to Dose Modifications
Dose modifications include treatment interruptions and dose reductions.
Time frame: Approximately 3, 6, and 12 months
Number of Treatment Interruptions Due to AEs
Time frame: Approximately 3, 6, and 12 months
Duration of Treatment Interruptions Due to AEs
Time frame: Approximately 3, 6, and 12 months
Time to Treatment Discontinuation due to Adverse Events (TTDAE)
Time frame: 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
Time frame: 3 months
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment
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Time frame: 6 months
MMR in Patients Aged > 40 years
MMR is defined as BCR::ABL1 IS ≤ 0.1%.
Time frame: 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.
Time frame: Approximately 12 months
Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment
Time frame: Up to 12 months prior to Baseline
Duration of CML at Time of Asciminib Treatment Initiation
Time frame: Baseline
Asciminib Starting Dose
Time frame: Baseline
Number of Patients With Dose Modifications
Number of patients with dose modifications including up titration or dose reduction.
Time frame: Approximately 3, 6, and 12 months
Number of Treatment Interruptions
Time frame: Approximately 3, 6, and 12 months
Duration of Treatment Interruptions
Time frame: Approximately 3, 6, and 12 months
Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching
Time frame: Approximately 3, 6, and 12 months
Number of Patients by Reason for Treatment Switch
Time frame: 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)
Time frame: Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline