Observational study on the effectiveness of asciminib for chronic myelogenous leukemia in Saudi Arabia

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)

This study is testing how well the drug asciminib works for people in Saudi Arabia with chronic myelogenous leukemia who have already tried other treatments.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: imatinib, dasatinib, nilotinib, bosutinib, ponatinib, asciminib
• Locations: 4 sites (Dammam and 3 other locations)
• Trial ID: NCT06684964 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the real-world effectiveness, tolerability, adherence, healthcare resource utilization, and patient-reported outcomes of asciminib in patients with Ph+ Chronic Myelogenous Leukemia in chronic phase who have previously been treated with at least two tyrosine kinase inhibitors. The study will enroll approximately 40 patients over a 6-month period from six centers in Saudi Arabia, following them for 12 months. Data will be collected from electronic medical records, and the decision to prescribe asciminib will be made independently by physicians.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Ph+ Chronic Myelogenous Leukemia in chronic phase who have been treated with at least two prior tyrosine kinase inhibitors and are currently receiving asciminib.

Not a fit: Patients who have not been prescribed asciminib or those who have not received at least two prior tyrosine kinase inhibitors will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and tolerability of asciminib, potentially improving treatment strategies for patients with chronic myelogenous leukemia.

How similar studies have performed: While this study focuses on real-world data, similar studies evaluating the effectiveness of asciminib have shown promising results, indicating a potential for success.

Eligibility criteria

Inclusion Criteria:

Patients eligible for inclusion in this study must meet all the following criteria:

1. Signed and dated Patient Informed Consent Form obtained.
2. Male or female patients with a diagnosis of Ph+ CML-CP ≥18 years of age with the following laboratory values:

   1. \<15% blasts in peripheral blood and bone marrow
   2. \<30% blasts plus promyelocytes in peripheral blood and bone marrow
   3. \<20% basophils in the peripheral blood
   4. ≥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:

1. Asciminib based treatment regimen in first or second line.
2. Patients are currently participating in any other clinical trials.
3. Patients who refused to sign informed consent.
4. 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.

Where this trial is running

Dammam and 3 other locations

• Novartis Investigative Site — Dammam, Saudi Arabia (Recruiting)
• Novartis Investigative Site — Jeddah, Saudi Arabia (Recruiting)
• Novartis Investigative Site — Riyadh, Saudi Arabia (Recruiting)
• Novartis Investigative Site — Riyadh, Saudi Arabia (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Chronic Myelogenous Leukemia in Chronic Phase; Chronic Myelogenous Leukemia in chronic phase; CML-CP; Asciminib