Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT
2026年9月14日 更新者：Xiao-Jun Huang、Peking University People's Hospital
Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation
This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation.
After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged <55 years) followed by unified post-transplant immunosuppression and supportive care.
The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.
研究概览
研究类型
介入性
注册 (估计的)
120
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yu Wang
- 电话号码：8610-8832-6005
- 邮箱：ywyw3172@sina.com
学习地点
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-
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Beijing、中国
- 招聘中
- Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University
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接触：
- Xiaojun Huang
- 电话号码：8610-8832-6005
- 邮箱：huangxiaojun@bjmu.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation
Exclusion Criteria:
- Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Age-Stratified Conditioning Regimen
MDS patients without identical sibling donor or unrelated donor would receive haplo-HSCT.
Participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged <55 years) followed by unified post-transplant immunosuppression and supportive care.
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RTC preconditioning regimen consisted of cytarabine (2g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m2/day, days -6 to -2), semustine (250 mg/m2, day-3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
Bu/Cy preconditioning regimen consisted of tandard institutional myeloablative busulfan + cyclophosphamide + rabbit ATG regimen per department routine dosing guidelines.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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transplant-related mortality (TRM)
大体时间：Participants will be followed for an expected average of 1 years
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Death without disease progression or relapse
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Participants will be followed for an expected average of 1 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hematopoietic engraftment
大体时间：Day 30 and Day 90 post-transplantation
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Neutrophil engraftment is defined as the first day of sustained absolute neutrophil count (ANC) ≥0.5×10⁹/L for 3 consecutive days; platelet engraftment is defined as the first day of sustained platelet count (PLT) ≥20×10⁹/L without transfusion support for 7 consecutive days.
Cumulative incidence of neutrophil engraftment at Day 30 and platelet engraftment at Day 90 will be calculated.
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Day 30 and Day 90 post-transplantation
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Cumulative incidence of graft-versus-host disease (GVHD)
大体时间：Day 100 and 3 years after transplantation
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Cumulative incidence of Grade II-IV and Grade III-IV acute GVHD at Day 100, as well as chronic GVHD and moderate-severe chronic GVHD within 3 years after transplantation, graded per Seattle criteria.
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Day 100 and 3 years after transplantation
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Cumulative incidence of CMV and EBV reactivation
大体时间：1 year after transplantation
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Defined as any detectable CMV or EBV viral load elevation requiring clinical intervention within 1 year after transplantation.
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1 year after transplantation
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Cumulative incidence of hematologic relapse
大体时间：1 year after transplantation
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Defined as bone marrow blast recurrence or extramedullary disease relapse within 1 year after transplantation.
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1 year after transplantation
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Disease-free survival (DFS)
大体时间：1 year after transplantation
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Defined as the time from transplantation until hematologic relapse or death from any cause.
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1 year after transplantation
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Overall survival（OS）
大体时间：1 year after transplantation
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Defined as the time from treatment until death from any cause or the last follow-up.
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1 year after transplantation
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Conditioning-related organ toxicities
大体时间：From conditioning start to Day 30 post-transplantation
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Incidence of grade 1-4 cardiac, renal, hepatic, gastrointestinal and oral mucosal toxicities from conditioning initiation to Day +30 post-transplantation, with separate analysis of Grade 3-4 severe organ injury, hepatic veno-occlusive disease (VOD), and conditioning-related death, graded per WHO organ toxicity scale.
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From conditioning start to Day 30 post-transplantation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiao-Jun Huang、Peking University Institute of Hematology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月15日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年6月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年6月30日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.