Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Grade III-IV acute graft versus host disease (GVHD)
研究概览
简要总结
This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.
详细描述
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups.
GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.
After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).
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
- •Signed informed consent
- •Able to take oral medications
- •Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed
- •Planned GVHD prophylaxis using one of the following regimens:
- •Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate
- •Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF)
- •Sirolimus plus cyclosporine plus MMF
- •Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF or sirolimus)
- •One of the following HCT donor types:
- •Human leukocyte antigen (HLA)-matched sibling donor
- •9/10 or 10/10 HLA-matched unrelated donor
- •HLA- haploidentical donor
- •Cord blood
- •Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after
- •Not pregnant or breast feeding
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: Absolute neutrophil count (ANC) recovery to > 0.5 x 10^9/L from nadir, without ongoing growth factor support
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: Discontinuation of all antibacterial antibiotics (except those used for Pneumocystis jiroveci prophylaxis) for 2 days
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade II-IV acute GVHD
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: No moderate to severe chronic GVHD
- •ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibiotics to treat infections. Prophylactic antiviral and antifungal antibiotics used to prevent infections are allowed
排除标准
- •Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
- •History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
- •Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD. The use of other experimental agents is prohibited unless approved by the principal investigator (PI) of the other trial
研究组 & 干预措施
Group I (fecal microbiota transplant)
Patients receive fecal microbiota capsules PO QD for 7 days
干预措施: Fecal Microbiota Transplantation Capsule (Drug)
Group II (Placebo)
Patients receive placebo PO QD for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Grade III-IV acute graft versus host disease (GVHD)
时间窗: Up to 6 months post hematopoietic cell transplantation (HCT)
Based on International Blood and Marrow Transplantation Research (IBMTR) criteria and measured as a probability
次要结局
- Grade II-IV acute GVHD(Up to 180 days post HCT)
- Non-relapse mortality(Up to 180 days post HCT)
- Clostridium difficile diarrhea(Up to 180 days post HCT)
- Chronic GVHD(At 12 months post-HCT)