A Multi-center Prospective Clinical Study in China Using CliniMACS TCRα/β+ and CD45RA+ T Cell Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Stem Cell Transplantation in Children With Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Log number of In Vitro T cells depletion
研究概览
简要总结
This is a multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.
详细描述
This clinical study will the CliniMACS TCRα/β and CD45RA Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donors to treat pediatric patients who were suffuring form relapsed or refactory leukemia.
Aming to evaluate the safety/tolerability and feasibility of haploidentical PBSC grafts depleted of TCRα/β+ and CD45RA+ cells using the CliniMACS TCRαβ/CD45RA System in pediatric patients with hematological malignancies diseases. And the incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation of this new In Vitro T cell depletion technology in China.
The investigators will monitor the incidence of grade I acute GVHD until Day 100 post-transplantation, incidence and severity of chronic GVHD after 1 year and 2 years, incidence of NRM at all visits throughout the study, and graft failure from Day 0 to Day 28 at the same time.
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
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- •Acute myeloid leukemia (AML):
- •Patients with high-risk AML in CR1 Patients with relapsed or primary therapy-refractory AML
- •Acute lymphoid leukemia (ALL):
- •Patients with high-risk ALL in CR1 Patients with relapsed or primary refractory ALL
排除标准
- •Age >18 years or <8 weeks
- •Patients with progressive disease prior HCT
- •<3 months after preceding hematopoietic cell transplantation (HCT)
- •History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection)
- •Fungal infections with radiological and clinical progression
- •Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
- •Chronic active viral hepatitis
- •Ejection fraction <40% or shortening fraction <25% on echocardiography
- •Patients with > grade II hypertension by Common Toxicity Criteria (CTC)
- •Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard
- •Respiratory failure necessitating supplemental oxygen
- •HIV infection
- •Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study
- •Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- •Patients unwilling or unable to comply with the protocol or unable to give informed consent
- •Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP)
结局指标
主要结局
Log number of In Vitro T cells depletion
时间窗: One week
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Incidence of grade II-IV acute GVHD
时间窗: up to 3 months
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
次要结局
- NRM(1 year)
- cGVHD(2 years)
- Grade I aGVHD(up to 3 months)
- Graft failure(1 month)