Radiation Therapy for Non-Hodgkin's Lymphoma

Overseen By Sarah Neufeld

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Auto-immune disease, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-arm open-label phase I/II trial studying the safety and efficacy of focal 're-priming' radiation therapy (RT) to FDG-avid residual sites of disease in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) patients with incomplete response (IR) to CAR T-cell therapy (CAR-T) by day 30 post-CAR-T PET/CT. We hypothesize that focal 're-priming' RT will be safe (phase I) and improve conversion to metabolic complete response (CR) by day 90 post-CAR-T PET/CT from 29% (historical control) to 58% (phase II).

Research Team

Kiran Kumar, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

Adults over 18 with certain types of non-Hodgkin lymphoma who didn't fully respond to previous CAR T-cell therapy can join. They must be in relatively good health, understand the study, and agree to use birth control. People with brain involvement by cancer, severe side effects from prior treatments, very short life expectancy or conditions that could limit following the trial rules cannot participate.

Inclusion Criteria

I have previously received a CD19 CAR T-cell therapy.

I have a confirmed diagnosis of a specific type of aggressive lymphoma.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

I've had specific radiation therapy for areas where my cancer didn't fully respond after CAR-T treatment.

Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

I do not have severe side effects from CAR-T therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive focal radiation therapy to all residual FDG-avid sites as noted on day 30 post-CAR-T PET/CT scan

4 months

Regular visits for radiation therapy administration

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, including assessment of metabolic complete response at day 90 post-CAR-T PET/CT

1 year

Follow-up visits at day 90 and 1 year post-CAR-T

Treatment Details

Interventions

• Focal radiation therapy (RT)

Trial Overview The trial is testing if adding focal radiation therapy to areas where cancer remains after CAR T-cell treatment helps patients achieve a complete response. It's an early phase trial aiming to see if this approach is safe and more effective than past results without radiation.

Participant Groups

Group I: Radiation Therapy to all residual FDG-avid sites* Experimental Treatment 1 Intervention

All patients enrolled in the trial will receive focal radiation therapy (RT) to all\* residual FDG-avid sites per Lugano criteria (Lugano 4-5) as noted on day 30 post-CAR-T PET/CT scan. \*If \>5 distinct sites, physician discretion will be allowed as to how many sites are treated, with recommendation that at least all symptomatic and bulky (\>=7.5 cm in largest dimension) sites be treated.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+