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