NCT02323867进行中（未招募）2 期
UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC MALIGNANCIES
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
研究概览
简要总结
This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Leukemias/lymphomas
- •Acute myeloid leukemia, primary or secondary Disease status: remission or <10% bone marrow blasts
- •Myelodysplasia
- •Acute lymphoblastic leukemia Disease status: in hematologic remission
- •Chronic myelogenous leukemia Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
- •Mixed lineage or biphenotypic acute leukemia
- •Lymphoblastic lymphoma Disease status: remission
- •Burkitt's lymphoma/leukemia: Disease status- in remission
- •Acceptable organ status clearance
- •No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
- •Signed informed consent.
- •Negative pregnancy test for females of childbearing potential.
排除标准
- •Patients who do not meet disease, organ or infectious criteria.
- •No suitable donor
- •Received previous allogeneic transplant
- •Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.
结局指标
主要结局
Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
时间窗: 1 year
次要结局
- Severe acute and chronic graft versus host disease (GVHD)(1 year)
研究者
Timothy Olson
Medical Director, Hematopoietic Stem Cell Transplantation (HSCT) Program
Children's Hospital of Philadelphia
研究点 (2)
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