NCT06218602招募中2 期
Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.
详细描述
Primary Objectives
- To assess the toxicity of combination of FMT with anti-CD19 Axicabtagene ciloleucel therapy and compare it with standard of care Arm B with anti-CD19 CAR-T arm
- To assess the response in participants treated with the combination of FMT and Axicabtagene ciloleucel CAR T-cell therapy at day 30 and compare it with standard of care Arm B with anti-CD19 CAR-T arm.
Secondary Objectives
- To assess PFS and OS among participants with and without FMT.
- To assess changes in gut microbiome of lymphoma participants after FMT.
- To assess dynamic changes in serum and stool metabolites after FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •At least 18 years of age on the day of signing informed consent.
- •Histologically/cytologically confirmed diagnosis of B-cell lymphomas.
- •Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.
- •Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam.
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Evaluation of ECOG is to be performed within 7 days prior to the date of signing study consent.
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Absolute neutrophil counts should be greater than 1000/ul at the time of administration of fecal enema.
- •Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed], an AST, level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN
- •Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.
- •Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first study-drug administration, for the duration of trial treatment, and for at least for 12 months after treatment for females and 4 months after treatment for males. Should a female patient (or male participant's sexual partner) become pregnant or should either the female patient (or male participant's partner) suspect she is pregnant while the participant's study-participation is ongoing, the treating physician should be informed immediately.
排除标准
- •If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- •Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- •Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the study subject's best interest to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Pregnant or nursing women
- •For women of childbearing age, a serum pregnancy test will be required within 72 hours prior to enrollment. If the serum test is positive, patient will not be allowed to enroll in the trial.
- •Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial.
- •Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)
研究组 & 干预措施
Arm A
Experimental
Will receive FMT therapy (both as a colonoscopy / FMT procedure and as capsules taken by mouth) plus the scheduled chemotherapy and CAR-T cell therapy.
干预措施: Fecal Microbiota Transplantation (Drug)
Arm A
Experimental
Will receive FMT therapy (both as a colonoscopy / FMT procedure and as capsules taken by mouth) plus the scheduled chemotherapy and CAR-T cell therapy.
干预措施: CAR-T Therapy (Procedure)
Arm B
Experimental
Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy.
干预措施: CAR-T Therapy (Procedure)
Arm A
Experimental
Will receive FMT therapy (both as a colonoscopy / FMT procedure and as capsules taken by mouth) plus the scheduled chemotherapy and CAR-T cell therapy.
干预措施: Chemotherapy (Procedure)
Arm B
Experimental
Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy.
干预措施: Chemotherapy (Procedure)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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