2022-501831-18-00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
Maat Pharma56 个研究点 分布在 5 个国家目标入组 374 人开始时间: 2023年3月3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
- 374
- 试验地点
- 56
- 主要终点
- Parameter: Overall survival (OS). For this endpoint, OS is defined as the time from the date of alloHCT to the date of death from any cause.
研究概览
简要总结
To compare the efficacy of MaaT033 with its placebo on overall survival at 12 months after alloHCT
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase II evaluating of oral pooled fecal microbiotherapy MaaT033 to prevent alloHCT complications
- 盲法
- Double (Subject, Monitor, Investigator, Carer, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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. Note: - Reduced toxicity or reduced intensity conditioning regimen is defined as any conditioning regimen that does not fit the definitions provided in the exclusion criteria. - Subjects planned to receive sequential protocols combining salvage chemotherapy with reduced intensity conditioning (RIC) and alloHCT can be included in the trial.
- •Polynuclear neutrophils > 0.5 G/L.
- •Received wide spectrum antibiotics within the last 90 days prior to inclusion. Note: Use of wide spectrum antibiotic is defined as use of at least 3 days of antibiotics within the last 90 days prior to inclusion, which is defined as randomization. For the list of wide spectrum antibiotics, refer to section 5.1 of Protocol.
- •Karnofsky index ≥ 70%.
- •Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor.
- •Signature of informed and written consent by the subject or by the subject’s legally acceptable representative for subjects under guardianship or trusteeship.
排除标准
- •Planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent).
- •Documented bilirubin or amino-transferases abnormalities contra-indicating alloHCT. Note: Bilirubin > 3 x Upper normal limits (ULN), or Aspartate Transaminase / Alanine Transaminase (AST/ALT) > 5 x ULN to be considered as an exclusion criterion.
- •Documented cardiac ejection fraction less than 40%. Note: The most recent cardiac ejection fraction measured in the previous 6 months prior screening documenting values below 40%.
- •Documented pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO). Note: The most recent DLCO measured in the previous 6 months prior screening documenting values below 50%.
- •Pregnancy and breastfeeding (urine or serum pregnancy test within 72 hours prior to randomization). Subjects (males and females of childbearing potential) should be willing to use an acceptable method of birth control such as hormonal contraception (progestogen-only may be sufficient), male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide for the course of the study (up to M12). A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable. A female is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 Months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 Months of amenorrhea, a single FSH measurement is insufficient.
- •Documented confirmed or suspected intestinal ischemia.
- •Documented confirmed or suspected toxic megacolon, bowel obstruction or gastrointestinal (GI) perforation.
- •Any documented history of GI surgery in the past 3 months.
- •Any documented history of chronic digestive disease (Crohn’s disease, ulcerative colitis (UC), inflammatory bowel disease or other relevant digestive condition according to physician’s judgement).
- •Known allergy or intolerance to trehalose or maltodextrin.
- •Negative EBV-IgG serology.
- •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).
- •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 subjects such as: persons deprived of liberty, persons in Intensive Care Unit (ICU) unable to provide ICF prior to the intervention, persons under legal protection according to the national law.
- •Other ongoing interventional protocol that might interfere with the current study’s primary endpoint. Note: Subjects previously included in interventional trials and no longer receiving the previous study medication but in follow-up, can participate in the PHOEBUS trial with a wash-out period of 5 half-lives of previous study medication as long as they meet all respective inclusion and none of the exclusion criteria.
- •Receiving a manipulated graft (in-vitro T-cell depletion).
- •Planned to receive a conditioning regimen with alemtuzumab (CAMPATH®).
- •Planned to receive alloHCT with cord blood cells.
- •Planned to receive alloHCT from unrelated donor with ≥ 3/10 HLA-mismatches.
- •Receiving a large spectrum antibiotic at time of randomization.
- •Planned to receive vedolizumab or abatacept for GvHD prophylaxis.
- •Documented creatinine clearance <30 mL/min.
结局指标
主要结局
Parameter: Overall survival (OS). For this endpoint, OS is defined as the time from the date of alloHCT to the date of death from any cause.
Parameter: Overall survival (OS). For this endpoint, OS is defined as the time from the date of alloHCT to the date of death from any cause.
次要结局
- See table 1 of the protocol for details
研究者
Head of Clinical Development Department
Scientific
Maat Pharma
研究点 (56)
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