Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia in Chronic Phase | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| asciminib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Asciminib
- description
- Patients who have been receiving asciminib for up to 6 months prior to study start
- interventionNames
- Other: asciminib
Primary outcomes (1)
- measure
- Major molecular response (MMR)
- timeFrame
- Month 12
- description
- MMR is defined as a breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 protein (BCR-ABL1) transcript level ≤0.1%, at 12 months.
Secondary outcomes (6)
- measure
- Frequency and severity of hematologic and non-hematologic AEs
- timeFrame
- Up to 12 months
- description
- Frequency and severity of hematologic and non-hematologic AEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available