NCT07552649尚未招募2 期
MATCH-Treg: Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia
Antonio Pierini2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants free from disease 2 years after HSCT
研究概览
简要总结
The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML with adverse genetic mutations in Complete Remission (CR) or incomplete (i) CR according to ELN 2022 recommendations with or without MRD positivity at the time of the HSCT procedure;
- •Diagnosis of AML with intermediate genetic mutations in Complete remission (CR) or incomplete (i) CR according to ELN 2022 with MRD positivity at the time of the transplant;
- •Fitness to undergo allo-HCT with myeloablative conditioning regimens according to center policy;
- •Availability of a family HLA-matched hematopoietic stem cell donor suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
- •Age ≥ 18 and ≤ 70 years
- •HCT-CI ≤ 4
- •Signature of the informed consent
排除标准
- •Prior allo-HSCT
- •AML with favorable genetic abnormalities
- •AML with intermediate genetic risk with MRD negativity
- •Active disease at transplant (> 5% bone marrow infiltration)
- •Availability of a haploidentical or matched unrelated donor (MUD)
- •Age < 18 years or > 70 years
- •ECOG > 2
- •Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- •Uncontrolled bacterial, viral, or fungal infections at time of enrollment
- •Pregnancy
- •No signature of the informed consent
研究组 & 干预措施
Myeloablative contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation
Experimental
All enrolled patients will receive a myeloablative conditioning regimen followed by the infusion of HLA-matched donor graft and Treg/Tcon adoptive immunotherapy
干预措施: HSCT with Treg/Tcon adoptive immunotherapy (Biological)
结局指标
主要结局
Number of participants free from disease 2 years after HSCT
时间窗: 2 years
The primary objective of the study is to reduce the incidence of disease relapse after myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched donors in high-risk AML patients.
次要结局
- Number of participants that have reached engraftment 45 days after HSCT(45 days)
- Number of participants that developed grade ≥ 2 acute GvHD(100 days)
- Number of participants free from chronic GvHD 2 years after HSCT(2 years)
- Number of participants who died for transplant related mortality after HSCT(2 years)
- Number of patients free from ≥ 2 acute GvHD and/or moderate/severe chronic GvHD and/or relapse(2 years)
- Number of patients free from moderate/severe chronic GvHD and relapse(2 years)
- Number of patients alive after 2 years after allogeneic transplant(2 years)
研究者
Antonio Pierini
Sponsor-Principal Investigator
University Of Perugia
研究点 (2)
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