JPRN-UMIN000011192已完成2 期
Hematopoietic stem cell transplantation from a related donor with HLA-1 Ag mismatch in the graft-versus-host direction using anti-thymocyte globulin as a GVHD prophylaxis: multicenter phase II trial. - HSCT from a related donor with HLA-1 Ag mismatch using ATG
HLA Working Group, the Japan Society for Hematopietic Cell Tranplantation. Research Grant for Allergic Disease and Immunology (H23-009) from the Japanese Ministry of Health, Labor, and Welfare.0 个研究点目标入组 39 人开始时间: 2013年7月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
39 patients were eligible for the analysis. The 1-year GRFS was 47%. The 3-year OS was 57%. Age of less than 50 years was associated with better OS. OS in patients with high/very high refined disease risk indexes (rDRIs) was comparable to that in those with low/intermediate rDRIs. The 100-day cumulative incidences of grades II-IV and III-IV acute GVHD were 45% and 18%, respectively. Three-year cumulative incidences of moderate to severe or severe chronic GVHD were 13% and 3%, respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients with positive donor-specific HLA antibodies 2. Patients with HBs antibody positive 3. Patients with HIV antibody positive 4. Patients with serious mental disorder who are likely unable to participate in the study 5. Patients who are pregnant, nursing, or possibly pregnant 6. Patients with coexistence of malignancy 7. Patients with poorly controlled active infection 8. Patients who are allergic to ATG 9. Patients who have a history of receiving allogeneic stem cell transplantation once or more or a history of receiving autologous stem cell transplantation twice or more
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