NCT06684964 RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
| NCT ID | NCT06684964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Chronic Myelogenous Leukemia in Chronic Phase |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-03-24 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06684964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Myelogenous Leukemia in Chronic Phase. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06684964 currently recruiting?
Yes, NCT06684964 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06684964 trial being conducted?
This trial is being conducted at Dammam, Saudi Arabia, Jeddah, Saudi Arabia, Riyadh, Saudi Arabia, Riyadh, Saudi Arabia.
Who is sponsoring the NCT06684964 clinical trial?
NCT06684964 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 40 participants.
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