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临床试验/NCT03232268
NCT03232268已完成1 期

HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment

研究概览

简要总结

This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
  • HLA-partially matched family donors
  • Affiliated to(or beneficiary of) the Social Security
  • Informed consent signed

排除标准

  • Previous Hematopoietic Stem Cell TRansplantation
  • Uncontrolled infection -PS>3 -Other progressive cancer
  • Psychiatric disease
  • Vulnerable person or unable to provide informed consent
  • Emergency
  • Unable to comply with required study follow up

研究组 & 干预措施

HLA-mismatched microtransplantation

Experimental

HLA-mismatched microtransplantation without immunosuppressive treatment

干预措施: HLA-mismatched microtransplantation (Biological)

结局指标

主要结局

Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment

时间窗: 100 days after transplantation

Cumulative incidence of acute GVH (grade 1 to 4)

次要结局

未报告次要终点

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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