安全地提供有针对性的高剂量照射，然后采用调节性和常规T细胞的继发性免疫疗法，以增加高危急性白血病中造血干细胞移植的效力 (SHARP)
2025年3月1日 更新者：Antonio Pierini、University Of Perugia
敏锐的 - 安全地传递的有针对性的高剂量照射，然后采用调节性和常规T细胞的过养免疫疗法，以增加高危急性急性白血病中造血干细胞移植的效力
这项研究是一项单中心的介入研究，该研究评估了同种异体HLA匹配或单倍性移植的功效，该移植包括基于辐射的调节方案以及供体Treg/TCON收养免疫疗法对高危急性白血病患者的疗效。
研究概览
研究类型
介入性
注册 (估计的)
51
阶段
- 不适用
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：Antonio Pierini
- 电话号码：+39 +393355477611
- 邮箱：antonio.pierini@unipg.it
研究联系人备份
- 姓名：Loredana Ruggeri
- 电话号码：+39 +393388953982
- 邮箱：loredana.ruggeri@ospedale.perugia.it
学习地点
-
-
PG
-
Perugia、PG、意大利、06100
- 招聘中
- Università degli Studi di Perugia
-
接触：
- Antonio Pierini, MD, PhD
- 电话号码：3355477611
- 邮箱：antonio.pierini@unipg.it
-
-
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
纳入标准：
AML患者
- 与同种异体造血细胞移植有关AML的诊断。
- 在移植手术过程中，诊断不良遗传风险白血病或存在MRD或活性疾病（骨髓浸润5-30％）的诊断。
- 适用于患者的造血干细胞供体（家族或与患者无关的HLA匹配或HLA-Haploidentical）的可用性，适用于用G-CSF（10 mcg/kg/die）治疗的最多7天，并能够耐受2或更多的白细胞。
- 年龄≥18岁和≤65岁
- ECOG≤2
- HCT-CI≤4（51,52）
- 缺乏相关的精神病
- 知情同意的签名
所有患者
- 诊断所有T或B（费城负）或混合表型的诊断，表明同种异体移植
- MRD或活动疾病（骨髓浸润5-30％）或移植手术时患有≥第二完全血液学缓解的患者。
- 适用于患者的造血干细胞家族供体（家族或与患者无关的HLA匹配或HLA-Haploidentical）适用于使用G-CSF（10 mcg/kg/die）治疗的最多7天，并能够耐受2或更多的liukaphereses。
- 年龄≥18岁和≤65岁
- ECOG≤2
- HCT-CI≤4
- 缺乏相关的精神病
- 知情同意的签名
排除标准：
AML患者
- AML在mrd中
- AML具有> 5％的外围爆炸或骨髓浸润≥30％
- 年龄<18岁或> 65岁
- ECOG> 2
- 根据临床判断
- 怀孕
- 没有知情同意的签名
所有患者
- 全部> 5％的外围爆炸或骨髓浸润≥30％
- 费城积极
- 年龄<18岁或> 65岁
- ECOG> 2
- 根据临床判断
- 怀孕
- 没有知情同意的签名
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 |
|---|---|
|
实验性的：同种异体细胞移植中基于TMLI的扭曲和TREG/TCON收养免疫疗法
所有注册的患者将接受20GY-TMLI的调节方案，然后输注供体移植和Treg/TCON收养免疫疗法
|
在同种异体细胞移植中，将20 Gy TMLI与Treg/TCON收养免疫疗法组合
|
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 |
|---|---|---|
|
HSCT 2年后，没有疾病的参与者人数
大体时间：2年
|
该研究的主要目的是减少基于辐照的调节方案和TREG/TCON继发性免疫疗法后的疾病复发的发生率，这些基于HLA匹配或单倍型供体在高风险急性白血病患者中的同种异体移植。
|
2年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HSCT后45天植入的参与者人数
大体时间：45天
|
该研究还将评估具有基于辐照的调节方案和TREG/TCON继发性免疫疗法对高风险急性白血病患者（例如完全捐助者类型的高风险移植）的主要移植结果的同种异体匹配或单倍型供体对主要移植结果的影响。
|
45天
|
|
发展≥2级急性GVHD的参与者数量
大体时间：2年
|
该研究还将评估具有基于辐照的调节方案和TREG/TCON继发性免疫疗法对高风险急性白血病患者的主要移植结果的同种异体匹配或单倍型供体的同种异体移植物的影响。
|
2年
|
|
HSCT 2年后，没有慢性GVHD的参与者数量
大体时间：2年
|
该研究还将评估具有基于辐照的调节治疗方案和TREG/TCOR收养免疫疗法对高风险急性急性白血病患者的主要移植结果的同种异体匹配或单倍型供体的影响。
|
2年
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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)
2025年2月25日
初级完成 (估计的)
2029年1月1日
研究完成 (估计的)
2031年1月1日
研究注册日期
首次提交
2025年2月14日
首先提交符合 QC 标准的
2025年2月19日
首次发布 (实际的)
2025年3月25日
研究记录更新
最后更新发布 (实际的)
2025年3月25日
上次提交的符合 QC 标准的更新
2025年3月1日
最后验证
2025年2月1日
更多信息
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