JPRN-jRCTs031180397已完成未知
A pilot study for hematopoietic stem cell transplantation with post-transplantation cyclophosphamide and anti-thymoglobulin from HLA-mismatched related donor for non-malignant diseases
Kato Motohiro0 个研究点目标入组 6 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
Hematopoietic cell transplantation with PTCy and low-dose ATG from HLA-mismatched related donors was feasible to control GVHD for non-malignant diseases in the children.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 至 < 25age old（—）
- 性别
- All
入选标准
- •1) Diagnosed as bone marrow failure, immunodeficiency, or inborn errors of metabolism
- •2) Fanconi anemia is excluded for bone marrow failure.
- •3) No HLA 5/6 (A, B, DR) or more matched related donor
- •4) No HLA 6/6 (A, B, DR) matched unrelated donor
- •5) Transplantation from 2- or more-antigen mismatched related donor
- •6) Age at transplantation <25 years
- •7) ECOG Performance status: 0-2
- •8) Sufficient organ function, as follows;
- •a. T-Bil <= 1.5 mg/dl
- •b. Serum creatinine <= 0.8 mg/dl (age <5y), <= 1.2 mg/dl (age 5-9y), <= 1.5 mg/dl (10y or older)
- •c. Ejection fraction 45% or better, and QTfc <0.45 sec
- •9) Obtained informed consent from a guardian of the patient
排除标准
- •1. Effusion with grade 2 or worse at CTCAE ver 4.0
- •2. Uncontrolled infection
- •3. Severe psychological disorders
- •4. Pregnant or suspected pregnancy
- •5. Not eligible for this study at the discretion of the investigator.
研究者
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A pilot study for hematopoietic stem cell transplantation with post-transplantation cyclophosphamide and anti-thymoglobulin from HLA-mismatched related donor for non-malignant diseases (Halo-NM)on-malignant diseases (bone marrow failure, immunodeficiency, inborn errors of metabolism)JPRN-UMIN000026159ational Center for Child Health and Development9
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