NCT03359980已完成2 期
Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer
MaaT Pharma16 个研究点 分布在 3 个国家目标入组 24 人开始时间: 2018年8月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 16
- 主要终点
- Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion
研究概览
简要总结
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.
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
- •Patients who develop a first episode of Stage 2 to 4 Gastro-intestinal Acute Graft-versus-Host (GI-aGVHD) with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose) (SR GI-aGVHD)
- •Age ≥ 18 years old
- •Allogeneic Hematopoietic stem cell transplantation (Allo-HSCT) with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- •Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT
- •Signature of informed and written consent by the subject or by the subject's legally acceptable representative
排除标准
- •Grade IV hyper-acute GVHD
- •Overlap chronic GVHD
- •Acute GVHD after donor lymphocytes infusion
- •Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- •Active uncontrolled infection according to the attending physician
- •Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs already being used for GVHD prevention (eg. calcineurin inhibitors) are allowed.
- •Absolute neutrophil count < 0.5 x 10^9 /L
- •Absolute platelet count < 10 000
- •Patient Epstein-Barr Virus (EBV) negative
- •Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray
- •Known allergy or intolerance to trehalose or maltodextrin
- •Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential
- •Other ongoing interventional protocol that might interfere with the current study primary endpoint.
研究组 & 干预措施
treated patients
Experimental
Treated with Fecal Microbiota Transfer (FMT)
干预措施: fecal microbiota transfer (Drug)
结局指标
主要结局
Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion
时间窗: up to 4 weeks post inclusion
Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR)
次要结局
- Number of patients with Chronic GVHD(through study completion, an average of six months)
- Gastrointestinal GVHD overall response rate at D28 post inclusion(Day 28)
- Number of multidrug resistant bacteria in faeces(through study completion, an average of six months)
- Safety of FMT in patients with SR-GI-aGVHD(through study completion, an average of six months)
- Number of patients with infectious disorders(through study completion, an average of six months)
研究者
研究点 (16)
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