Low-Dose Radiation Therapy for Diffuse Large B-Cell Lymphoma

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Overseen ByIIT Office Clinical Trails Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Nebraska
Must be taking: R-chemoimmunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. Researchers aim to determine if low-dose radiation therapy (LDRT) combined with standard chemoimmunotherapy can effectively target remaining cancer cells. The trial will test this approach on patients whose cancer appears in blood tests after initial treatment, while those without detectable cancer will continue regular treatment. This trial may suit adults newly diagnosed with DLBCL who plan to undergo chemoimmunotherapy. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial protocol 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 low-dose radiation therapy is safe for patients with diffuse large B-cell lymphoma?

Research has shown that low-dose radiation therapy (LDRT) is generally safe for patients with certain types of lymphoma, such as diffuse large B-cell lymphoma (DLBCL). One study found that using LDRT at doses like 2 × 2 Gy (a measure of radiation) effectively treated slower-growing lymphomas without major side effects. Another study found that LDRT at a dose of 8 Gy, administered in two parts, performed similarly to other radiation schedules but was less effective in preventing disease progression over time. Overall, studies have demonstrated that LDRT is a safe option, making it a promising choice for those with DLBCL.12345

Why are researchers excited about this trial's treatment strategy for DLBCL?

Most treatments for diffuse large B-cell lymphoma (DLBCL) involve chemotherapy and immunotherapy, typically working to kill cancer cells throughout the body. However, low-dose radiation therapy (LDRT) offers a unique approach by targeting specific sites with cancer activity, as identified by PET scans. This precision allows LDRT to focus on areas where residual disease is still present after initial treatment cycles, potentially improving outcomes without affecting the entire body. Researchers are excited because this targeted method may enhance the effectiveness of standard treatments while minimizing side effects.

What evidence suggests that low-dose radiation therapy might be an effective treatment for diffuse large B-cell lymphoma?

Studies have shown that low-dose radiation therapy (LDRT) can effectively treat diffuse large B-cell lymphoma (DLBCL). Research indicates that a lower radiation dose of about 20 Gy can still be effective for this type of lymphoma. In some cases, patients experienced high rates of cancer not returning in the treated area, with rates of 98.7% and 97.4% at 3 and 5 years after treatment, respectively. Additionally, the rates of patients living without cancer worsening were 91.7% and 87.2% at these same time points. In this trial, participants with detectable circulating tumor DNA minimal residual disease (ctDNA MRD) after cycle 2 of frontline chemoimmunotherapy and residual PET-avid disease may receive LDRT in addition to standard systemic therapy. This suggests that LDRT could be a promising option for managing DLBCL when guided by specific testing methods.26789

Who Is on the Research Team?

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Snegha Ananth, MBBS

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults (19+) with newly diagnosed diffuse large B-cell lymphoma or related subtypes who are starting standard chemoimmunotherapy. Participants must have measurable disease and enough tumor tissue for testing.

Inclusion Criteria

I am 19 years old or older.
I have a new diagnosis of large B-cell lymphoma and can get or have had one R-chemoimmunotherapy cycle.
I am planning to start R-chemoimmunotherapy as my first treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive frontline chemoimmunotherapy with MRD testing and interim PET imaging after two cycles. Patients with detectable MRD may receive low-dose radiation therapy.

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival assessments.

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Dose Radiation Therapy (LDRT)

Trial Overview

The study tests if using blood and scan results to guide adding low-dose radiation therapy to standard chemoimmunotherapy is safe and practical. Only patients with signs of remaining cancer after initial treatment get the extra radiation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm- A: MRD-Detectable with Protocol-Directed LDRT ConsiderationExperimental Treatment2 Interventions
Group II: Arm- B: MRD-Undetectable Standard TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Citations

Radiation Therapy for Relapsed or Refractory Diffuse Large B ...

A low-dose regimen of 8 Gy in 2 fractions was associated with similar ORR compared with other fractionation schema but trended towards inferior TTLF.

Long-term Update of a Phase 2 Study of Dose-Reduced ...

Long-term results of this phase 2 study, with a median follow-up of 9 years, did not demonstrate late local failures when patients received ∼20 Gy ...

Validity of reduced radiation dose for localized diffuse large B ...

There were no statistically significant differences between the lower and higher dose groups in progression-free survival, locoregional progression-free ...

Low Dose Radiation for Diffuse Large B Cell Lymphoma

Radiotherapy in younger patients · with advanced aggressive B-cell lymphoma-long-term results from the · phase 3 R-MegaCHOEP trial. Leukemia 2024;38:1099-1106 ...

Radiotherapy May Boost Survival for Certain Patients With ...

Patients had a lower risk of their diffuse large B-cell lymphoma (DLBCL) progressing if they had consolidative radiotherapy, a new report shows.

NCT05621096 | Low Dose Radiation as Bridging Therapy ...

This is a pilot study to evaluate the feasibility of low-dose radiation therapy in the bridging period between chimeric antigen receptor (CAR) T-cell collection ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27781290/

Low-dose radiotherapy in diffuse large B-cell lymphoma

Low-dose radiotherapy (LDRT) given in 2 × 2 Gy is a highly effective and safe treatment for palliation of indolent lymphomas.

Low‐dose radiotherapy in diffuse large B‐cell lymphoma

Low-dose radiotherapy (LDRT) given in 2 × 2 Gy is a highly effective and safe treatment for palliation of indolent lymphomas.

Validity of reduced radiation dose for localized diffuse large B ...

The results of this trial indicated that 30 Gy had the same efficacy as 40–50 Gy in cases of aggressive NHL. These results were convincing due to the large ...