A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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≥ 18 years
- •Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).
- •* Any intensive regimen with planned ~4 weeks of inpatient stay
- •Cohort B: Allo-HCT patients
- •* Any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)
- •Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo
- •Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
排除标准
- •Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC > 1,000)
- •Patients who are currently receiving or recently received (within 28 days) other investigational agents.
- •Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
研究组 & 干预措施
AML Patients undergoing Intensive Chemotherapy
干预措施: Fecal Microbiota Transplant (FMT) (Biological)
Patients undergoing Allo-HCT Patients
干预措施: Fecal Microbiota Transplant (FMT) (Biological)
Patients undergoing Allo-HCT Patients Control
干预措施: Placebo (Other)
AML Patients undergoing Intensive Chemotherapy Control
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
时间窗: 4 Months
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
次要结局
- FMT Engraftment(4 Weeks after first FMT treatment)
- Number of Bacterial Infections(4 Months after first FMT treatment)
- Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)(Day 180 post-HCT, up to 7 months)
- Number of BSI of Suspected Gut Origin(1 week after first FMT treatment)
- Number of Fungal Infections(4 Months after first FMT treatment)
- Number of Viral Infections(4 Months after first FMT treatment)
- FMT Engraftment(2 Weeks after first FMT treatment)