Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas

Официальное название

A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy

Обзор

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

Вмешательства

• Препарат Vancomycin 125mg
  oral
• Лучевая терапия Radiation Therapy
  Radiation Therapy
• Биопрепарат CAR-T
  standard of care anti-CD19 CAR-T

Первичные конечные точки

• Cytokine release syndrome [Срок оценки: date of CAR-T infusion to 28 days after infusion]
• Severe adverse events [Срок оценки: CAR-T infusion to 28 days after infusion]
• VRE [Срок оценки: start of vancomycin to day 28 after CAR-T infusion]
• Adverse Events [Срок оценки: start of vancomycin until day 28 after CAR-T infusion]

Вторичные конечные точки (2)

• Best overall response rate [Срок оценки: CAR-T infusion to 12 months after CAR-T infusion]
• Complete response rate [Срок оценки: CAR-T infusion to 12 months after CAR-T infusion]

Критерии участия

Критерии включения

• Male or female subject aged ≥ 18 years.
• Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T
• ECOG Performance Status ≤ 2.
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Abramson Cancer Center, University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07478848 · UPCC 69425 · 858761

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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