NCT07478848招募中1 期
A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- VRE
研究概览
简要总结
This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female subject aged ≥ 18 years.
- •Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T
- •ECOG Performance Status ≤
- •Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T
- •Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites
- •Subjects must have at least one site of measurable disease based on CT or FDG PET
- •Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma
- •For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.
- •The following age-specific requirements apply:
- •Women < 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses >1 year ago; or had chemotherapy-induced menopause with last menses >1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug
- •Known history of vancomycin resistant enterococcus (VRE)
- •Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis
- •History of radiation pneumonitis or other grade 4 radiation-related adverse event
- •Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.
- •Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.
- •Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.
- •Active infection that required the use of antibiotics within 4 weeks prior to registration
- •Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
研究组 & 干预措施
vancomycin, radiation therapy, and CAR-T
Experimental
vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells
干预措施: Radiation Therapy (Radiation)
vancomycin, radiation therapy, and CAR-T
Experimental
vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells
干预措施: CAR-T (Biological)
vancomycin, radiation therapy, and CAR-T
Experimental
vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells
干预措施: Vancomycin 125mg (Drug)
结局指标
主要结局
VRE
时间窗: start of vancomycin to day 28 after CAR-T infusion
rate of vancomycin-related enterococcus
Cytokine release syndrome
时间窗: date of CAR-T infusion to 28 days after infusion
rate of CART-related cytokine release syndrome
Severe adverse events
时间窗: CAR-T infusion to 28 days after infusion
rate of grade ≥ 3 adverse events attributed to vancomycin or radiation
Adverse Events
时间窗: start of vancomycin until day 28 after CAR-T infusion
rate of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Best overall response rate(CAR-T infusion to 12 months after CAR-T infusion)
- Complete response rate(CAR-T infusion to 12 months after CAR-T infusion)
研究者
研究点 (1)
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