Antileukemic Activity of Allogeneic Hematopoietic Stem Cell Transplantation With Fractionated Total Body Irradiation or Total Marrow and Lymph Node Irradiation Followed by Adoptive Immunotherapy With Regulatory and Conventional T Cells
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- chronic GvHD/relapse-free survival
研究概览
简要总结
To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk acute leukemias or other hematologic malignancy where HSCT is indicated.
详细描述
Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated with the use of a regulatory T cell based protocol. Hyper-fractionated Total Body Irradiation or Total Marrow and Lymphoid Irradiation based conditioning will be followed by the infusion of T regulatory and T conventional cell adoptive immunotherapy and a purified CD34+ hematopoietic stem cell graft. Incidence of Non Relapse Mortality, Relapse, acute Graft versus Host Disease, chronic Graft versus Host Disease, as well as probability of cGvHD/disease free survival will be assessed in patient subpopulations separated according to HLA-matching with the donor (HLA-matched HSCT and HLA-haploidentical HSCT) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML and ALL in complete remission and with high-risk of relapse
- •AML and ALL primarily chemoresistant or relapsed;
- •Chronic Myeloid Leukemia in accelerated or blastic phase;
- •Patients affected by
- •Multiple myeloma,
- •Non Hodgkin lymphoma,
- •Hodgkin lymphoma,
- •Chronic myeloproliferative syndrome,
- •Chronic Lymphoid Leukemia,
- •Other Hematological malignancy at high-risk of relapse or detectable disease and where a HSCT is indicated.
- •Age <75 years
- •Acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric diseases
- •Signature of the informed consent
排除标准
- •Age >75 years
- •ECOG > 2
- •Not acceptable lung, liver, kidney, and heart function and presence of relevant psichiatric diseases
- •Pregnancy
- •No signature of the informed consent
结局指标
主要结局
chronic GvHD/relapse-free survival
时间窗: 2 years
To evaluate if irradiation based myeloablative conditioning followed by Treg/Tcon adoptive immunotherapy improve chronic GvHD/relapse-free survival (GRFS) after allogeneic HSCT in patients affected by acute leukemias or other hematologic malignancies where HSCT is indicated. GRFS will be assessed in subgroups of patients separated according to HLA-matching with the donor and type of disease (acute myeloid lekemia, acute lymphoid leukemia, other)
次要结局
- full donor-type engraftment(30 days)
研究者
Andrea Velardi
Full Professor
University Of Perugia