2024-512969-14-01招募中2 期
Fecal Microbiota Transplantation in the prevention of complications after allogeneic hematopoietic stem cell transplantation for hematologic malignancy
CHU Gabriel-Montpied17 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2024年11月18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
- 165
- 试验地点
- 17
- 主要终点
- GRFS (Graft-versus-host disease and Relapse-Free Survival) rate at 1 year post-allograft.
研究概览
简要总结
To evaluate the effect of allogeneic FMT compared with no treatment on graft-versus-host disease-free, relapse-free survival (GRFS) at one year post-transplant in patients treated with myeloablative conditioning (MAC) allo-HSCT for haematological malignancy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent allo-HSCT for a controlled haematological malignancy
- •Patients aged ≥ 18 years old
- •Patients affiliated with a social security organization
- •Patients who had signed informed consent
- •With myelo-ablative type conditioning
- •With an allogeneic peripheral stem cell transplant, regardless of the type of donor (except cord blood)
排除标准
- •Patient with tumor progression status at the time of allo-HSCT
- •History of another progressive cancer or one occurring in the previous 3 years (excluding basal cell carcinoma)
- •Faecal incontinence
- •Allograft of HSC from bone marrow
- •Patient suffering from a serious and uncontrolled concomitant condition (severe cardiac, renal, hepatic or respiratory failure, serious sepsis)
- •Patient under guardianship, curatorship or safeguard of justice
结局指标
主要结局
GRFS (Graft-versus-host disease and Relapse-Free Survival) rate at 1 year post-allograft.
GRFS (Graft-versus-host disease and Relapse-Free Survival) rate at 1 year post-allograft.
次要结局
- Survival at 1 and 2 years (overall and progression-free)
- Evaluation of hematological criteria
- Assessment of GVHD
- Incidence of infectious complications
- Tolerance and safety of post-allo-HSCT FMT
- Evolution of the composition and diversity of the microbiota
- Quality of life
研究者
Lise laclautre
Scientific
CHU Gabriel-Montpied
研究点 (17)
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