RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
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)
Novartis Pharmaceuticals
40 participants
Mar 24, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- 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
- \. 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 Criteria5
- 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.
Interventions
This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06684964