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This is a non-interventional, prospective, observational single arm study describing the real-world effectiveness, tolerability, adherence, Healthcare Resource Utilization (HCRU) and Patient-Reported Outcome (PRO) data of asciminib in patients with Ph+ Chronic Myelogenous Leukemia - Chronic Phase (CML-CP) previously treated with ≥2 Tyrosine Kinase Inhibitor (TKIs) in routine clinical practice in Kingdom of Saudi Arabia.
Patients who have been receiving asciminib for up to 6 months prior to study start will be enrolled over a period of approximately 6 months and followed up for 12 months to assess study outcomes.
Each patient will be followed from baseline up to the earliest of death, loss to follow-up or end of the 12-month follow-up.
The study aims to enrol approximately 40 patients in a single arm design from a total of 6 centers in Kingdom of Saudi Arabia (KSA) over an enrollment period of approximately 6 months. These patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. The prescription of asciminib should align with its approved label use. Importantly, the decision to prescribe asciminib to these patients should have been made independently by the physician and not influenced by the study. Data will be collected from patient electronic medical records in the sites chosen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asciminib | Patients who have been receiving asciminib for up to 6 months prior to study start |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asciminib | Other | This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major molecular response (MMR) | MMR is defined as a breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 protein (BCR-ABL1) transcript level ≤0.1%, at 12 months. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of hematologic and non-hematologic AEs | Frequency and severity of hematologic and non-hematologic AEs | Up to 12 months |
| Major Molecular Response (MMR) Rate | MMR is defined as a BCR-ABL1 transcript level ≤0.1%. |
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Inclusion Criteria:
Patients eligible for inclusion in this study must meet all the following criteria:
Signed and dated Patient Informed Consent Form obtained.
Male or female patients with a diagnosis of Ph+ CML-CP ≥18 years of age with the following laboratory values:
4. Prior treatment with a minimum of 2 prior TKIs: e. First-generation TKI imatinib f. 2G-TKI dasatinib, nilotinib and bosutinib g. 3G-TKI ponatinib 4. Patients are currently receiving asciminib as per approved local label and independently of study participation. Patients must have started asciminib therapy no more than 6 months prior to their enrollment in the study.
Exclusion Criteria:
Patients meeting ANY of the following criteria are not eligible for participation:
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Patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. Patients will be included in the study regardless of their MMR status at the initiation of asciminib treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Dammam | 15215 | Saudi Arabia | ||
| Novartis Investigative Site |
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| Baseline, month 6, month 12 |
| Deep Molecular Response (DMR) Rate | Percentage of participants with MR4.0 and MR4.5:
| Month 6, month 12 |
| Cytogenetic Response (CCyR) Rate | Assessment of CCyR and/or [BCR-ABL1 transcript level ≤1%] | Month 6, month 12 |
| Duration of MMR | Assess the duration of MMR in participants. | Up to 12 months |
| Simplified Medication Adherence Questionnaire (SMAQ) score. | SMAQ assesses adherence to medication. It is a 6-item questionnaire that evaluates different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and omissions. A patient is classified as non-compliant if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. | Month 6, month 12 |
| Recruiting |
| Jeddah |
| 21423 |
| Saudi Arabia |
| Novartis Investigative Site | Recruiting | Riyadh | 11211 | Saudi Arabia |
| Novartis Investigative Site | Recruiting | Riyadh | 11426 | Saudi Arabia |
| ID | Term |
|---|---|
| C000621806 | asciminib |
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