Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
研究概览
简要总结
The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML patients in China in the real-world clinical practice setting.
详细描述
Breakpoint cluster region (BCR)
Abelson murine leukemia viral oncogene homolog 1 (c-ABL)
Chronic myeloid leukemia (CML)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Because this is a product registry study, it will include adult CML patients in any phase treated with dasatinib in China if they meet the following criteria:
- •Willing and able to provide written informed consent
- •≥18 years of age
- •Confirmed diagnosis of CML patients by attending physician
- •Naive to dasatinib before enrollment in study treatment or have received <3 months of dasatinib treatment
- •Plan to or are receiving dasatinib therapy based on physician's clinical judgment
- •Administered dasatinib after imatinib-resistance or intolerance
排除标准
- •Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies
研究组 & 干预措施
CML patients treated with dasatinib
Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel)
干预措施: Dasatinib (Drug)
结局指标
主要结局
Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
时间窗: Upto 2 years
Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow
Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase
时间窗: Upto 2 years
Molecular response is defined as no detectable BCR-ABL observed through Quantitative polymerase chain reaction (Q-PCR) (International Scale) using an assay with a sensitivity of at least 4.5 logs below the standardized baseline
Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase
时间窗: Upto 2 years
Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood
次要结局
- Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire(Upto 2 years)
- Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire(Upto 2 years)
- Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib(Upto 2 years)
- Progression-free survival (PFS)(Upto 2 years)
- Overall survival (OS)(Upto 2 years)
- Safety of dasatinib measured by incidence and severity of adverse events(Upto 2 years)