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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | 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. |
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Inclusion Criteria
Exclusion Criteria
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CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Approximately 3, 6, and 12 months |
| Incidence of AEs Leading to Dose Modifications | Dose modifications include treatment interruptions and dose reductions. | 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 |
| Time to Treatment Discontinuation due to Adverse Events (TTDAE) | 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 | 3 months |
| Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment | 6 months |
| MMR in Patients Aged > 40 years | MMR is defined as BCR::ABL1 IS ≤ 0.1%. | Approximately 12 months |
| Rate of Deep Molecular Response | Deep molecular response includes:
| Approximately 12 months |
| Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment | Up to 12 months prior to Baseline |
| Duration of CML at Time of Asciminib Treatment Initiation | Baseline |
| Asciminib Starting Dose | Baseline |
| Number of Patients With Dose Modifications | Number of patients with dose modifications including up titration or dose reduction. | Approximately 3, 6, and 12 months |
| Number of Treatment Interruptions | Approximately 3, 6, and 12 months |
| Duration of Treatment Interruptions | Approximately 3, 6, and 12 months |
| Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching | Approximately 3, 6, and 12 months |
| Number of Patients by Reason for Treatment Switch | Approximately 3, 6, and 12 months |
| Number of Patients by Clinicopathological Characteristics | Clinicopathological characteristics include:
| Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |