RecruitingNCT06684964

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

40 participants

Start Date

Mar 24, 2025

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world observational study looking at how well asciminib — a newer targeted drug for a type of leukemia called chronic myeloid leukemia (CML) — works in patients in Saudi Arabia in everyday clinical practice. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (CML-CP) - You have already been treated with at least 2 prior targeted therapies (TKIs) - You are currently taking asciminib as prescribed by your doctor, and started it no more than 6 months ago **You may NOT be eligible if...** - Asciminib is your first or second treatment for CML - You are already enrolled in another clinical trial - You refused to sign the consent form - Your doctor believes you would not be able to provide reliable medical history or attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERasciminib

This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.


Locations(4)

Novartis Investigative Site

Dammam, Saudi Arabia

Novartis Investigative Site

Jeddah, Saudi Arabia

Novartis Investigative Site

Riyadh, Saudi Arabia

Novartis Investigative Site

Riyadh, Saudi Arabia

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NCT06684964