RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
NCT ID: NCT06684964
Last Updated: 2025-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-03-24
2026-07-30
Brief Summary
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Detailed Description
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Each patient will be followed from baseline up to the earliest of death, loss to follow-up or end of the 12-month follow-up.
The study aims to enrol approximately 40 patients in a single arm design from a total of 6 centers in Kingdom of Saudi Arabia (KSA) over an enrollment period of approximately 6 months. These patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. The prescription of asciminib should align with its approved label use. Importantly, the decision to prescribe asciminib to these patients should have been made independently by the physician and not influenced by the study. Data will be collected from patient electronic medical records in the sites chosen.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asciminib
Patients who have been receiving asciminib for up to 6 months prior to study start
asciminib
This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.
Interventions
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asciminib
This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.
Eligibility Criteria
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Inclusion 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
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.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Jeddah, , Saudi Arabia
Novartis Investigative Site
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CABL001ASA01
Identifier Type: -
Identifier Source: org_study_id