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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological, Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
Pennsylvania
Abramson Cancer Center, University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Rachel Lundberg, PA-C
rachel.lundberg@pennmedicine.upenn.edu
215-615-5858
Backup
Megan Jones, MPH
megan.jones1@pennmedicine.upenn.edu
Time Frame
Start Date: 2026-05-29
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 14
Treatments
Experimental: vancomycin, radiation therapy, and CAR-T
vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells
Sponsors
Leads: Abramson Cancer Center at Penn Medicine
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov