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

Launched by NOVARTIS PHARMACEUTICALS · Nov 11, 2024

Keywords

ClinConnect Summary

The ASC4REAL trial is a study looking at how well a medication called asciminib works for patients with a type of blood cancer known as Chronic Myelogenous Leukemia (CML) who are already in a chronic phase of the disease. This study will gather information from patients in Saudi Arabia who have tried at least two other treatments before starting asciminib. The goal is to understand how effective the medication is, how well patients can tolerate it, and how committed they are to taking it as prescribed.

To be eligible for this study, patients must be at least 18 years old, have specific lab results showing their CML is stable, and currently be using asciminib as part of their treatment. Participants will be observed in their regular healthcare settings, and their experiences and health outcomes will be documented over time. It’s important to note that this study is not yet recruiting participants, and those who are interested or think they might qualify will need to provide their consent before joining.

Gender

ALL

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.