NCT05288595撤回2 期
TCR Alpha/Beta and CD19-depleted Allogeneic Hematopoietic Cell Transplant for Malignant and Non-Malignant Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Incidence of severe (grade III-IV) acute graft-versus-host disease (GVHD) at day 100 after infusion of a TCRαβ+/CD19+ negative, peripheral blood stem cell (PBSC) product without additional GVHD prophylaxis.
研究概览
简要总结
This is an open label, interventional, non-randomized, phase II trial of TCR alpha/beta and CD19-depeleted allogeneic HCT in pediatric patients with hematologic disease.
详细描述
This is a single-site, open label, interventional, non-randomized, phase II trial of TCRαβ/CD19 deplete allogeneic HCT as donor source and sole GVHD prophylaxis in pediatric patients with either malignant or non-malignant hematologic disease who are eligable for allogeneic HCT, but lack a HLA-matched sibling donor.
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
- 31 Days 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 31 days to <30 years
- •Have a malignant or non-malignant hematologic disease, defined as disease resulting from abnormal function of a cell of the hematopoietic stem cell lineage, that could benefit from an allogeneic HCT. Examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias/marrow failure, white blood cell abnormalities, red blood cell abnormalities, and platelet abnormalities.
- •Clinical remission for patients with acute leukemia (MDS/AML excluded) or lymphoma
- •Lack a healthy and willing HLA-identical related donor, with the exception of patients with FA who will be eligible with a willing HLA-identical related donor given the standard use of T-cell depletion in matched sibling donor HCT in FA
- •Have a related or an unrelated donor who meets the donor selection criteria, is healthy, willing, and able to receive GCSF with or without Plerixafor, and undergo apheresis through placement of catheters in the antecubital veins or a temporary central venous catheter
- •Able to give informed consent if ≥ 18 years, or with legal guardian capable of giving informed consent if < 18 years
- •Provision of signed and dated informed consent form
排除标准
- •Uncontrolled, active infection at time of HCT
- •HIV positivity
- •Cardiac ejection fraction <45%
- •Creatinine clearance <60 mL/min/1.72 mL
- •Pulmonary diffusion capacity (adjusted for hemoglobin), FEV1, or FVC <60% of predicted or an O2 saturation <94% on room air if unable to perform pulmonary function testing
- •Serum ALT >5x upper limit of normal or bilirubin >2
- •Performance score (Lansky or Karnofsky) <50
- •Pregnant or lactating females, as many medications necessary for a successful HCT are potentially harmful to unborn babies and infants.
结局指标
主要结局
Incidence of severe (grade III-IV) acute graft-versus-host disease (GVHD) at day 100 after infusion of a TCRαβ+/CD19+ negative, peripheral blood stem cell (PBSC) product without additional GVHD prophylaxis.
时间窗: 5 years
Grade to be determined using Acute GVHD Staging Scale
次要结局
- Number of patients with non-engraftment(100 days)
- Post-HCT infections(100 days)
- Number of patients with relapse(1 year)
- Number of treatment-related mortality (TRM)(1 year)
- Disease-free Survival (DFS) measured in days(1 year)
- Overall Survival (OS) measured in days(1 year)
- Immune Reconstitution(1 year)
研究者
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