A Randomized Open Label Pilot Study of Clostridium Butyricum MIYAIRI 588 (CBM588) in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This pilot trial studies the side effects and how well CBM588 works in improving clinical outcomes in patients who have undergone donor hematopoietic stem cell transplant. Gut microbiota (formerly called gut flora) is the name given to the microbe (bacteria) population living in the intestine. Gut bacteria help the body to digest certain foods that the stomach and small intestine have not been able to digest. CBM588, may increase gut bacteria biodiversity, prevent recurrent symptoms of gastrointestinal toxicity (ranging from diarrhea to life-threatening inflammation of the colon).
详细描述
PRIMARY OBJECTIVES:
I. In patients with hematologic malignancies who are undergoing standard reduced intensity conditioning regimen (RIC) prior to allogeneic stem cell transplantation, to evaluate the safety and feasibility of Clostridium butyricum CBM 588 probiotic strain (CBM588) treatment by assessing:
Ia. Type, frequency, severity, attribution, time course and duration of adverse events, including diarrhea, bloodstream/intestinal infections.
Ib. Patient compliance, the patients' ability to take CBM588 during the treatment period.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Documented informed consent of the participant and/or legally authorized representative.
- •Assent, when appropriate, will be obtained per institutional guidelines.
- •Willingness to be followed for the planned duration of the trial (2 years).
- •Karnofsky performance status must be >= 60%.
- •Any hematologic disorders receiving allogeneic hematopoietic stem cell transplant with reduced intensity conditioning.
- •Planned 8/8 or 7/8 (human leukocyte antigens [HLA]-A, B, C, DR) related or unrelated donor hematopoietic cell transplantation (HCT).
- •Clinical Laboratory and Organ Function Criteria: Consistent with City of Hope (COH) standard operating procedure (SOP) for "patient evaluation for selection for hematopoietic cell transplantation.
- •Patient is eligible to receive allogeneic hematopoietic cell transplantation with reduced intensity conditioning.
- •Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy.
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).
排除标准
- •Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study. A legal guardian may substitute for the research participant.
- •Refusing to use contraception up to 90 days post-HCT.
- •Pregnant and/or breast feeding if a female recipient.
- •Patients with history of chronic intestinal disease (e.g., Crohn's disease, ulcerative colitis).
- •In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment.
- •Research participants receiving any other investigational agents.
- •Known or documented history of hypersensitivity to all the listed antibiotics, used for severe infections related to CBM588:
- •Ampicillin.
- •Chloramphenicol.
- •Clindamycin.
- •Erythromycin.
- •Metronidazole.
- •Tetracycline.
- •Vancomycin.
- •Research participants with presence of other active malignancy within 2 years of study entry. Participants with history of prior malignancy treated with curative intent who achieved complete response (CR) more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (i.e., research participants whom are severe lactose intolerance or intolerance to milk products).
- •Research participants having any uncontrolled illness including ongoing or active infection. Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections.
- •Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
研究组 & 干预措施
Arm I (CBM588)
Patients receive standard peri-/post-transplant supportive care and CBM588 PO BID from day of admission to day 28 in the absence of disease progression or unacceptable toxicity.
干预措施: Best Practice (Other)
Arm I (CBM588)
Patients receive standard peri-/post-transplant supportive care and CBM588 PO BID from day of admission to day 28 in the absence of disease progression or unacceptable toxicity.
干预措施: Clostridium butyricum CBM 588 Probiotic Strain (Drug)
Arm II (standard of care)
Patients receive standard peri-/post-transplant supportive care.
干预措施: Best Practice (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: From initiation of treatment until end of treatment assessed up to 100 days
Will be scored according to the modified Bearman Scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 scale. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Feasibility of CBM588
时间窗: During the safety lead-in phase
Will be evaluated by assessment of patients' ability to take half of the specified dose.
次要结局
- Cumulative incidence (CI) of chronic graft versus host disease (cGVHD)(Up to 2 years)
- Incidence and severity of adverse events(Up to 2 years)
- Overall survival(Up to 2 years)
- CI of acute graft versus host disease (aGVHD)(Up to 2 years)
- CI of relapse/progression of disease(Up to 2 years)
- Non-relapse mortality(Up to 2 years)