JPRN-jRCTs031220607招募中2 期
Phase II study of salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure - JSCT Salvage PTCy-Haplo
Onizuka Makoto0 个研究点目标入组 20 人开始时间: 2023年2月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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 <= 70age old（—）
- 性别
- All
入选标准
- •1. primary engraftment failure after allogeneic hematopoietic stem cell transplantation for hematological disease, primary immunodeficiency, and congenital metabolic disorder
- •2. any stage and disease status
- •3. Age <= 70
- •4. PS 0-3
- •5. any history of autologous or allogeneic stem cell transplantation
- •6. no evidence of severe organ dysfunction (ejection fraction >=50, total bilirubin <=2.0, CCr >=30, SpO2 >=90% (O2 <=4L/min)
- •7. consent to join this study
- •8. a HLA haploidentical donor is available
排除标准
- •1. positive anti-HIV antibody
- •2. active cancer
- •3. need for vasopressor
- •4. pregnancy
- •5. allergic to cyclophosphamide, melphalan, fludarabine, tacrolimus, and mycophenolate Mofetil
- •6. need for chemotherapy before protocol therapy
- •7. concomitant relapse of primary malignancy
- •8. recurrent engraftment failure
- •9. presence of donor-specific anti-HLA antibody
- •10. judgment by physician
研究者
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