A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 17
- 主要终点
- Rate of discontinuation of index TKI due to AEs
研究概览
简要总结
This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of Ph+-CML-CP diagnosis.
- •Receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy.
- •Receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic).
- •Signed informed consent form (ICF) prior to participation in the study including agreement to be tokenized so that the patient's anonymized RWD (EMRs and/or claims data) can be accessed.
排除标准
- •Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease.
- •Currently being treated with a CML TKI in 3L or beyond.
- •Known presence of T315I mutation.
- •Currently in TFR phase and are not on active CML TKI therapy.
- •Previously received treatment with a prior stem cell transplant
- •Pregnant or nursing (lactating) female.
研究组 & 干预措施
Nilotinib
Patients who started 1L or 2L nilotinib on or after Oct-2021
干预措施: TKIs (Other)
Imatinib
Patients who started 1L or 2L imatinib on or after Oct-2021
干预措施: TKIs (Other)
Asciminib
Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care
干预措施: TKIs (Other)
Bosutinib
Patients who started 1L or 2L bosutinib on or after Oct-2021
干预措施: TKIs (Other)
Dasatinib
Patients who started 1L or 2L dasatinib on or after Oct-2021
干预措施: TKIs (Other)
结局指标
主要结局
Rate of discontinuation of index TKI due to AEs
时间窗: Up to 5 years
Rate of discontinuation of index Tyrosine kinase inhibitor (TKI) due to Adverse Events (AEs)
次要结局
- Overview of AEs(Up to 5 years)
- Rate and time to switches in TKI(Up to 5 years)
- Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio(Up to 5 years)
- Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to 5 years)
- Functional Assessment of Chronic Illness Therapy - Item-GP5 (FACIT GP5)(Up to 5 years)
- Distributions of the PRO instrument Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-GH-10)(Up to 5 years)
- Distributions of the PRO instrument Medication Adherence Report Scale - 10 (MARS-10)(Up to 5 years)
- Rates of molecular responses at/by specified timepoints(Up to 5 years)
- Duration of molecular responses(Up to 5 years)
- Rates of complete hematological response (CHR) at/by specified timepoints(Up to 5 years)
- Failure-free survival (FFS)(Up to 5 years)
- Progression-free survival (PFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)