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New treatment option for Large B Cell Lymphoma
Official title Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
ClinicalTrials.gov ID: NCT07478848
What this study is testing
What is Vancomycin 125mg?
Vancomycin 125mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female subject aged ≥ 18 years.
- Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T
- ECOG Performance Status ≤ 2.
- people must be clinically eligible to receive standard of care anti-CD19 CAR-T
- people must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites
You likely can't join if
- 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...
- 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 how well it works...
- Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.
See the full eligibility 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.
- people must be clinically eligible to receive standard of care anti-CD19 CAR-T
- people must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites
- people must have at least one site of measurable disease based on CT or FDG PET
- people must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma
- For female people: 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...
- 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
- 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 how well it works 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.