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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Major molecular response (MMR)
研究概览
简要总结
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.
详细描述
Patients who have been receiving asciminib for up to 6 months prior to study start will be enrolled over a period of approximately 6 months and followed up for 12 months to assess study outcomes.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Major molecular response (MMR)
时间窗: Month 12
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.
次要结局
- Frequency and severity of hematologic and non-hematologic AEs(Up to 12 months)
- Major Molecular Response (MMR) Rate(Baseline, month 6, month 12)
- Deep Molecular Response (DMR) Rate(Month 6, month 12)
- Cytogenetic Response (CCyR) Rate(Month 6, month 12)
- Duration of MMR(Up to 12 months)
- Simplified Medication Adherence Questionnaire (SMAQ) score.(Month 6, month 12)