NCT07073690已完成不适用
Real-World Treatment Patterns and Outcomes of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes (LR-MDS) in China ('REACH' Study)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年4月18日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Participant red blood cell transfusion independence
研究概览
简要总结
The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participants ≥ 18 years of age.
- •Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice)
- •Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status.
- •Historical documentation of anemia before luspatercept treatment.
排除标准
- •Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
- •Received stem cell transplant prior to luspatercept treatment initiation.
研究组 & 干预措施
Participants receiving luspatercept treatment
干预措施: Luspatercept (Drug)
结局指标
主要结局
Participant red blood cell transfusion independence
时间窗: Up to 12-weeks
Participants mean hemoglobin (Hb) increase ≥1.5 g/dL
时间窗: Up to 12-weeks
次要结局
- Participant transfusion independence and increase in hemoglobin (Hb)(Up to 48 weeks)
- Duration of luspatercept monotherapy treatment(Up to 48 weeks)
- Health Care Resource Utilization (HCRU)(Up to 48 weeks)
研究者
研究点 (1)
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