NCT06918834招募中2 期
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial
Institute of Hematology & Blood Diseases Hospital, China5 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2025年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 5
- 主要终点
- 2-year Disease-Free Survival (DFS) post-HSCT
研究概览
简要总结
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
详细描述
A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years
- •High relapse risk MDS, defined by:
- •IPSS-R score ≥3.
- •IPSS-M stratification as intermediate-high, high, or very high risk.
- •Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
- •Karnofsky Performance Status (KPS) ≥
- •Signed informed consent.
排除标准
- •Severe organ dysfunction:
- •Left ventricular ejection fraction <50%.
- •Oxygen supplementation requirement.
- •Serum bilirubin >1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT >5x upper limit of normal.
- •Estimated glomerular filtration rate (eGFR) <50 mL/min.
- •History of prior allogeneic HSCT.
- •Any condition deemed unsuitable by the investigator.
研究组 & 干预措施
Immediate HSCT Group
Experimental
干预措施: Immediate HSCT Group (Other)
Bridging Therapy Group
Active Comparator
干预措施: Bridging Therapy Group (Other)
结局指标
主要结局
2-year Disease-Free Survival (DFS) post-HSCT
时间窗: 2-year
Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment
次要结局
- Cumulative Incidence of Allogeneic HSCT(The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.)
- Complete Remission (CR) or CR Equivalent Rate from Randomization(2-year)
- 2-year Overall Survival (OS) post-HSCT(2-year)
- 2-year Leukemia-Free Survival (LFS) from Randomization(2-year)
- 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization(2-year)
- Molecular Clearance Rate(2-year)
- Complete Remission (CR) or CR Equivalent Rate from Randomization(2-year)
- Cumulative Incidence of Allogeneic HSCT(The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.)
- 2-year Overall Survival (OS) post-HSCT(2-year)
- 2-year Leukemia-Free Survival (LFS) from Randomization(2-year)
- 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization(2-year)
- Molecular Clearance Rate(2-year)
研究者
研究点 (5)
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