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
- 否
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
研究点 (1)
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