Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)Cells After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Safety Measures
研究概览
简要总结
The purpose of the Phase IIA study are to:
- define the safety profile
- evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular, cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The progression free survival and the overall survival after the sequential infusion of Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.
详细描述
This study is an open-label, multicenter, exploratory phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro expanded Cytokine Induced Killer(CIK) cells.
Two infusions of unmanipulated donor lymphocytes (1x106/Kg each) will be given with a minimum interval of 3 weeks. Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). In presence of grade 2 or more acute graft versus host disease(GVHD), the patient will not receive the next scheduled infusion. Only grade 4 acute graft versus host disease (aGVHD) is considered for the dose limiting toxicity (DLT). Once identified the maximally tolerated dose (MTD), this same combination of doses will be administered up to 24 patients in a two-stage minimax design.
Primary Endpoints
The primary endpoints of the Phase IIA study are:
- the Maximally Tolerated Dose (MTD) - (safety end-point)
- the cumulative incidence of molecular, karyotypic or haematologic responses at day +100 after the end of the cell therapy program - (efficacy end-point)
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
- •Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with a molecular, cytogenetic or haematologic relapse after allogeneic transplantation.
- •Patients with an available donor willing to donate peripheral blood lymphocytes
- •Immunosuppression must be withdrawn at the beginning of the cell therapy program
- •Written informed consent prior to any study procedures being performed
排除标准
- •Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis
- •Patients with active acute or chronic Graft versus host disease (GvHD)
- •Patients with rapidly progressive disease or not controlled by palliative supportive treatments including chemotherapy and with a life expectancy less than 8 weeks
- •Patients with severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study
研究组 & 干预措施
Cytokine Induced Killer
Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)
干预措施: in vitro expanded Cytokine Induced Killer (CIK) cells (Biological)
结局指标
主要结局
Safety Measures
时间窗: Clinical response was measured at 100 days after the completion of the cell therapy program.
The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale
次要结局
- Efficacy Measures(The clinical response will be registered at day +100 after the last Cytokine Induced Killer (CIK) cell infusion)
研究者
Rambaldi Alessandro
Prof
A.O. Ospedale Papa Giovanni XXIII