Radiation Therapy for Non-Hodgkin's Lymphoma

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KD
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Overseen BySarah Neufeld
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new radiation therapy for treating non-Hodgkin's lymphoma (a type of blood cancer) in patients who didn't fully respond to previous CAR T-cell therapy. The goal is to determine if this treatment is safe and can help more patients achieve complete remission (no signs of cancer) by targeting specific cancer sites. This trial is open to those diagnosed with high-grade non-Hodgkin’s lymphoma who have undergone CAR T-cell therapy but still show signs of cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this radiation therapy is safe for non-Hodgkin's lymphoma patients?

Research has shown that radiation therapy is generally safe for people with non-Hodgkin's lymphoma. One study found that using radiation therapy before CAR T-cell therapy was both safe and effective. Most patients achieved excellent local control, meaning the cancer remained controlled where the radiation was applied. Another study found that radiation therapy alone yielded good results for non-Hodgkin's lymphoma patients. Although radiation can cause side effects, these studies suggest it is well-tolerated in similar situations.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Non-Hodgkin's Lymphoma, which often include chemotherapy, immunotherapy, or whole-body radiation, this investigational approach involves focal radiation therapy. This treatment is unique because it targets only the residual FDG-avid sites, as identified by PET/CT scans, rather than the entire body. This precision means that it can potentially minimize side effects and focus on areas that are still active after initial treatments. Researchers are excited because this method could offer a more tailored treatment option, especially for patients with specific symptomatic or bulky lesions.

What evidence suggests that focal radiation therapy is effective for relapsed/refractory non-Hodgkin's lymphoma?

Research has shown that radiation therapy can help treat non-Hodgkin's lymphoma (NHL). Studies have found that adding radiation therapy to treatment plans for diffuse large B-cell lymphoma, a type of NHL, can lead to better outcomes. In this trial, all participants will receive focal radiation therapy, which targets specific areas of the disease, at all residual FDG-avid sites. This approach may increase the chances of a full response in patients who haven't fully responded to other treatments, such as CAR T-cell therapy. Overall, evidence suggests that radiation therapy can be a beneficial addition for managing NHL that has returned or is not responding to other treatments.13678

Who Is on the Research Team?

KK

Kiran Kumar, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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
See 4 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Radiation Therapy to all residual FDG-avid sites*Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

Comparative efficacy of different chemotherapies for non- ...This network meta-analysis (NMA) was conducted to integrate different chemotherapeutic regimens for non-Hodgkin lymphoma (NHL) patients.
Reduced dose hypofractionated radiotherapy (3 Gy x ...While standard RT doses (24 Gy in 12 fractions) provide excellent disease control, they are associated with toxicity.
Radiotherapy for non-Hodgkin lymphomas: 2020 State of the ...Radiation therapy improves treatment outcome in patients with diffuse large B-cell lymphoma. Leukemia & Lymphoma 2011;52(10):1867–72. [DOI] ...
Single-agent rituximab and ultra-low-dose adaptive ...Indolent non-Hodgkin lymphomas (iNHLs) make up over 80% of all NHL cases (1). Focal radiation therapy (RT) is an effective treatment for ...
The Evolving Role of Radiation Therapy in DLBCLWith the addition of RT, the 5-year PFS rate was 86%, similar to that among patients who had a negative interim PET-CT. Only 2 of these patients ...
Outcomes of patients with R/R B-cell NHL and limited (<5 sites ...Bridging radiotherapy (BRT) before CART infusion has shown to be safe and effective with excellent local control (LC) rates >80%.11 It helps ...
Stable use of radiotherapy in lymphoma patients over time ...The use of RT in first-line lymphoma treatment was stable over calendar time. RT monotherapy is associated with encouraging outcomes among patients with NHL ...
or whole brain radiotherapy in patients with primary CNS ...Median overall survival (OS) from diagnosis was 24.1 months (95 % CI: 14.7–33.4), and median survival after RT was 7.2 months (95 % CI: 4.5–10.0) ...
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