Actively Recruiting
RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
Led by Novartis Pharmaceuticals · Updated on 2025-12-23
40
Participants Needed
4
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated Patient Informed Consent Form obtained
- Male or female patients 18 years of age or older diagnosed with Philadelphia chromosome-positive Chronic Myelogenous Leukemia in chronic phase
- Less than 15% blasts in peripheral blood and bone marrow
- Less than 30% blasts plus promyelocytes in peripheral blood and bone marrow
- Less than 20% basophils in peripheral blood
- Platelet count of 50 x 10^9/L (50,000/mm3) or higher
- Prior treatment with at least 2 Tyrosine Kinase Inhibitors including imatinib, dasatinib, nilotinib, bosutinib, or ponatinib
- Currently receiving asciminib as per approved local label, started no more than 6 months before enrollment
You will not qualify if you...
- Asciminib treatment used as first or second line therapy
- Currently participating in any other clinical trials
- Refusal to sign informed consent
- Considered unlikely by the investigator to provide accurate medical history or long-term follow-up due to unavailability or severe illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Novartis Investigative Site
Dammam, Saudi Arabia, 15215
Actively Recruiting
2
Novartis Investigative Site
Jeddah, Saudi Arabia, 21423
Actively Recruiting
3
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
4
Novartis Investigative Site
Riyadh, Saudi Arabia, 11426
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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