JPRN-jRCTs032230287招募中2 期
Clinical trial for HLA-haploidentical transplantation using alpha-beta T cell and B cell depletion
Iguchi Akihiro0 个研究点目标入组 3 人开始时间: 2023年8月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 18age old（—）
- 性别
- All
入选标准
- •1)Patients with Fanconi anemia or severe combined immunodeficiency who are difficult to receive allogeneic hematopoietic stem cell transplantation (HSCT) using PTCY.
- •2)At time of registration, patients who require allogeneic HSCT, but HLA7/8 antigen (A, B, C, DRB1) matched or 8/8 antigen matched donor is not available. Therefore, the intended donor is one of the following.
- •a. HLA4/8 antigen (A, B, C, DRB1) matched related donor.
- •b. HLA5/8 antigen (A, B, C, DRB1) matched related donor.
- •c. HLA6/8 antigen (A, B, C, DRB1) matched related donor.
- •3)Patients under 18 years of age at the time of HSCT.
- •4)Patients with an ECOG performance status (PS) score of 0-2 at enrollment.
- •5)Patients with adequate organ function who meet the following criteria at the time of enrollment. Laboratory findings must be within 30 days prior to enrollment.
- •a.Serum direct bilirubin <1.5mg/dL
- •b.Serum creatinine
- •<5 years old, <0.8mg/dL
- •5-9 years old, <1.2mg/dL
- •>10 years old, <1.5mg/dL
- •c.Ejection fraction>45% and QTc<0.45sec
- •6)Patients whose written consent from legal representative have been obtained to participate in this study.
排除标准
- •1) Patients who had received prior HSCT.
- •2) The donor is unable to use G-CSF due to allergy or other reasons.
- •3) Patients who have uncontrollable infection.
- •4) Patients with severe mental disorder.
- •5) Patients with pregnant or likely to be pregnant.
- •6) Patients who are ineligible by physician
研究者
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