RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)

Official title

Real-World Evidence Non-interventional Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib After Two Previous TKIs in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) in Saudi Arabia. (ASC4REAL)

Overview

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.

Detailed description

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.

Interventions

• Other asciminib
  This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.

Primary outcome measures

• Major molecular response (MMR) [Time frame: Month 12]

Secondary outcome measures (6)

• Frequency and severity of hematologic and non-hematologic AEs [Time frame: Up to 12 months]
• Major Molecular Response (MMR) Rate [Time frame: Baseline, month 6, month 12]
• Deep Molecular Response (DMR) Rate [Time frame: Month 6, month 12]
• Cytogenetic Response (CCyR) Rate [Time frame: Month 6, month 12]
• Duration of MMR [Time frame: Up to 12 months]
• Simplified Medication Adherence Questionnaire (SMAQ) score. [Time frame: Month 6, month 12]

Eligibility criteria

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:

• <15% blasts in peripheral blood and bone marrow
• <30% blasts plus promyelocytes in peripheral blood and bone marrow
• <20% basophils in the peripheral blood
• ≥50 x 109/L (≥50,000/mm3) platelets

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:

• Asciminib based treatment regimen in first or second line.
• Patients are currently participating in any other clinical trials.
• Patients who refused to sign informed consent.
• According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Saudi Arabia · 4 centers

• Novartis Investigative Site — Dammam
• Novartis Investigative Site — Jeddah
• Novartis Investigative Site — Riyadh
• Novartis Investigative Site — Riyadh

Identifiers

NCT: NCT06684964 · CABL001ASA01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗