NCT05762211招募中2 期
A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
MaaT Pharma54 个研究点 分布在 6 个国家目标入组 387 人开始时间: 2023年10月31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
- 招募中
- 发起方
- 入组人数
- 387
- 试验地点
- 54
- 主要终点
- Overall survival
研究概览
简要总结
This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years old
- •Presence of a hematologic malignancy for which an alloHCT is indicated with a reduced toxicity or reduced intensity conditioning regimen
- •Patients with polynuclear neutrophils > 0.5 G/L
- •Patients having received wide spectrum antibiotics within the last 90 days prior to inclusion
- •Karnofsky index ≥ 70%
- •Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor
- •Written informed consent
排除标准
- •Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent)
- •Patients planned to receive a conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kg IV) + high dose cyclophosphamide)
- •Patients receiving a manipulated graft (in-vitro T-cell depletion)
- •Patients planned to receive a conditioning regimen with alemtuzumab
- •Patients planned to receive alloHCT with cord blood cells
- •Patients planned to receive alloHCT from unrelated donor with >= 3/10 HLA-mismatches
- •Patients receiving a large spectrum antibiotic at time of randomization
- •Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
- •Creatinine clearance <30 mL/min
- •Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
- •Cardiac ejection fraction less than 40%
- •Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
- •Pregnancy
- •Confirmed or suspected intestinal ischemia
- •Confirmed or suspected toxic megacolon or gastrointestinal perforation
- •Any history of gastro-intestinal surgery in the past 3 months
- •Any history of chronic digestive disease (Crohn's disease, ulcerative colitis, inflammatory bowel disease or other relevant digestive condition according to physician's judgement)
- •Known allergy or intolerance to trehalose or maltodextrin
- •Patients with EBV-IgG negative serology
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- •Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
研究组 & 干预措施
Oral pooled fecal microbiotherapy - MaaT033
Experimental
3 capsules per day
干预措施: Pooled allogeneic fecal microbiotherapy (Drug)
Placebo capsule
Placebo Comparator
3 capsules per day
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: 12 months post alloHCT
To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT
次要结局
- Proportion of patients who have discontinued immune suppression therapies(12 months after alloHCT)
- GRFS(12 months post alloHCT)
- Quality of life questionnaire(12 months post alloHCT)
- Proportion of patients with severe infections(6 months after alloHCT)
- Restoration of gut microbiota diversity(12 months post alloHCT)
- grade 3-4 acute GvHD(12 months post alloHCT)
- Non-relapse mortality(12 months post alloHCT)
- GvHD-related mortality(12 months post alloHCT)
- Time to platelet engraftment(12 months after alloHCT)
- grade 2-4 acute GvHD(6 months post alloHCT)
- Time to neutrophil engraftment(12 months after alloHCT)
- Safety: incidence of AEs(12 months after alloHCT)
- Infectious-related mortality(12 months post alloHCT)
研究者
研究点 (54)
Loading locations...
相似试验
已完成
2 期
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)Moderate-to-severe Atopic DermatitisNCT04805411Keymed Biosciences Co.Ltd120
终止
2 期
A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPCProstate Cancer MetastaticNCT02378870DexTech Medical AB3
撤回
2 期
A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung CancerCarcinoma, Non-Small Cell LungNCT04611776Hoffmann-La Roche
已完成
2 期
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)NCT04906421Sagimet Biosciences Inc.168
招募中
2 期
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus, SLENCT05688696Beijing InnoCare Pharma Tech Co., Ltd.186