Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin 125mg, Radiation Therapy, CAR-T.
- Who it may be relevant to
- Registry conditions: Large B Cell Lymphoma, Non Hodgkin Lymphoma (NHL), Diffuse Large B Cell Lymphoma (DLBCL), Diffuse Large B Cell Lymphoma Refractory. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy
Overview
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
Interventions
- Drug Vancomycin 125mg
oral - Radiation Radiation Therapy
Radiation Therapy - Biological CAR-T
standard of care anti-CD19 CAR-T
Primary outcome measures
- Cytokine release syndrome [Time frame: date of CAR-T infusion to 28 days after infusion]
- Severe adverse events [Time frame: CAR-T infusion to 28 days after infusion]
- VRE [Time frame: start of vancomycin to day 28 after CAR-T infusion]
- Adverse Events [Time frame: start of vancomycin until day 28 after CAR-T infusion]
Secondary outcome measures (2)
- Best overall response rate [Time frame: CAR-T infusion to 12 months after CAR-T infusion]
- Complete response rate [Time frame: CAR-T infusion to 12 months after CAR-T infusion]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Abramson Cancer Center, University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07478848 · UPCC 69425 · 858761