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.
Study Type
OBSERVATIONAL
Enrollment
40
This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.
Novartis Investigative Site
Dammam, Saudi Arabia
RECRUITINGNovartis Investigative Site
Jeddah, Saudi Arabia
RECRUITINGNovartis Investigative Site
Riyadh, Saudi Arabia
RECRUITINGNovartis Investigative Site
Riyadh, Saudi Arabia
RECRUITINGMajor 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.
Time frame: Month 12
Frequency and severity of hematologic and non-hematologic AEs
Frequency and severity of hematologic and non-hematologic AEs
Time frame: Up to 12 months
Major Molecular Response (MMR) Rate
MMR is defined as a BCR-ABL1 transcript level ≤0.1%.
Time frame: Baseline, month 6, month 12
Deep Molecular Response (DMR) Rate
Percentage of participants with MR4.0 and MR4.5: * MR4.0 \[ BCR-ABL1 transcript level ≤0.01%\] * MR4.5 \[ BCR-ABL1 transcript level ≤0.0032%\]
Time frame: Month 6, month 12
Cytogenetic Response (CCyR) Rate
Assessment of CCyR and/or \[BCR-ABL1 transcript level ≤1%\]
Time frame: Month 6, month 12
Duration of MMR
Assess the duration of MMR in participants.
Time frame: 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.
Time frame: Month 6, month 12
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