NCT06684964Recruiting
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)
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 11 Nov 2024
- Start date
- 24 Mar 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06684964
What you commit to
- Study type: Observational
- Planned participants: 40
- From 24 Mar 2025 to the primary completion date, 30 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Dammam | Saudi Arabia | Recruiting |
| - Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Recruiting |
| - Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.