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