Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 163
- 试验地点
- 4
- 主要终点
- 1 year-cumulative relapse rate
研究概览
简要总结
Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Myelodysplastic syndromes;
- •Between 15 and 70 years old;
- •Subjects are able to provide written informed consent.
排除标准
- •Subjects who cannot comply with the study;
- •Patient has severe cardiac (ejection fraction <50%), hepatic (total bilirubin >34μmol/L, ALT, AST >2x upper limit of normal) or renal (blood creatinine >130μmol/L) disease；
- •Uncontrolled serious infection;
- •Other conditions that do not tolerate transplantation or other therapies.
研究组 & 干预措施
MDS-EB
干预措施: Detection of MDS-SC using MFC (Other)
结局指标
主要结局
1 year-cumulative relapse rate
时间窗: through study completion, an average of 1 year
Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.
次要结局
- Cumulative positive rate of measurable residual disease (MRD) after transplantation(through study completion, an average of 1 year)
- Disease-free survival (LFS)(through study completion, an average of 1 year)
- Overall survival (OS)(through study completion, an average of 1 year)
- Non-recurrent death (NRM)(through study completion, an average of 1 year)
- Transplant-related death (TRM)(through study completion, an average of 1 year)
- Acute graft-versus-host disease (GVHD)(through study completion, an average of 1 year)
- Chronic graft-versus-host disease (GVHD)(through study completion, an average of 1 year)
研究者
Chang Yingjun
Professor and Chief Physician
Peking University People's Hospital