2024-511651-17-00招募中2 期
A phase II multicenter single-armed study using subject-specific minimal residual minimal disease markers to adopt treatment after allogeneic stem cell transplantation for subjects with myleodysplastic syndrome - MDS
Karolinska University Hospital11 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2024年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1)
研究概览
简要总结
To prevent clinical events (relapse or non-relapse death) in minimal residual disease (MRD) positive subjects
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age ≥ 18 years
- •Subjects eligible for stem cell transplantation
- •Subjects having the disease myelodysplastic syndrome (MDS), mixed myelodysplastic/myeloproliferative syndrome or acute myeloid leukemia (AML) with myelodysplasia related dysplasia and 20-29% marrow blasts
- •All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study
排除标准
- •No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
- •Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
- •Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
结局指标
主要结局
The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1)
The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1)
次要结局
- MRD positive cohort: Relapse-free survival
- MRD positive cohort: GVHD and relapse-free survival
- MRD positive cohort: Proportion of MRD positive subjects achieving MRD-negativity
- MRD positive cohort: Incidence and severity of GVHD
- MRD positive cohort: Safety in MRD positive subjects subjected to MRD-guided clinical intervention
- Whole study cohort: Relapse-free survival
- Whole study cohort: GVHD and relapse-free survival
- Whole study cohort: Incidence and severity of GVHD
- Whole study cohort: Overall survival
研究者
Magnus Tobiasson
Scientific
Karolinska University Hospital
研究点 (11)
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