NCT06845592招募中不适用
SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 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 monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML patients
- •Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
- •Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
- •Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) 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 ≤ 65 years
- •HCT-CI ≤ 4 (51,52)
- •Absence of relevant psychiatric diseases
- •Signature of the informed consent
- •ALL patients
- •Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
- •Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
- •Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) 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 ≤ 65 years
- •HCT-CI ≤ 4
- •Absence of relevant psychiatric diseases
- •Signature of the informed consent
排除标准
- •AML patients
- •AML in CR MRD-
- •AML with > 5% peripheral blasts or bone marrow infiltration ≥ 30%
- •Age < 18 years or > 65 years
- •ECOG > 2
- •Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- •Pregnancy
- •No signature of the informed consent
- •ALL patients
- •ALL with > 5% peripheral blasts or bone marrow infiltration ≥30%
- •Philadelphia positive ALL
- •Age < 18 years or > 65 years
- •ECOG > 2
- •Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- •Pregnancy
- •No signature of the informed consent
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 irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched or haploidentical donors in high-risk acute leukemia 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(2 years)
- Number of participants free from chronic GvHD 2 years after HSCT(2 years)
研究者
Antonio Pierini
Principal Investigator
University Of Perugia
研究点 (2)
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