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

Recruitingn/aAges 18 Years - 99 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ2 Tyrosine Kinase Inhibitor (TKIs) in routine clinical practice in Kingdom of Saudi Arabia.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 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. โ‰ฅ50 x 109/L (โ‰ฅ50,000/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.
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What it tests

  • asciminib
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Where

4 sites
Novartis Investigative Site
Dammam, Saudi Arabia
Novartis Investigative Site
Jeddah, Saudi Arabia
Novartis Investigative Site
Riyadh, Saudi Arabia
Novartis Investigative Site
Riyadh, Saudi Arabia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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